2016/2057(INI) | [ParlTrack]

Draft opinion
Paragraph 1

1. Believes that the opinions of European citizens voiced by petitioning the European Parliament are fundamentally important in signalling to the European legislator issues that citizens feel concerned about, particularly the lack of access to, high prices of and inadequate distribution of medicines, the impact of ~~the economic crisis~~neoliberal policies and of cuts to public investment in health which have increased significantly since the economic crisis, the latter’s impact on medical and pharmaceutical care, and issues regarding marketing procedures and patents for medicinal products;

Amendment 10 #

Draft opinion
Paragraph 1 a (new)

1a. Recognises that the case of the highly priced medicine "sovaldi" for the treatment of hepatitis C has been a determining factor for giving serious consideration to the real difficulty to guarantee access to medicines around the world even in developed countries. In particular medicines to treat rare and oncological diseases;

Amendment 11 #

Draft opinion
Paragraph 1 a (new)

1a. Emphasises its concern at the burgeoning increase in the price of medicines, for example for Hepatitis C, which is taxing countries’ ability to maintain healthcare spending in the long term and ensure access to treatment for their citizens;

Amendment 12 #

Pál CSÁKY, Peter JAHR, Jarosław WAŁĘSA

Draft opinion
Paragraph 2

2. Calls for universal access to good quality, free public health services to be ensured in the Member States as the sole way of ensuring a high level of human health protection ~~to be ensured~~for the whole population in the definition and implementation of all the Union’s policies and activities, as required by Article 35 of the Charter of Fundamental Rights of the European Union;

Amendment 13 #

Draft opinion
Paragraph 2

2. ~~Calls for~~Points out that a high level of human health protection has to be ensured in the definition and implementation of all the Union’'s policies and activities, as enshrined in Article 168 of the Treaty on the Functioning of the European Union and required by Article 35 of the Charter of Fundamental Rights of the European Union;

Amendment 14 #

Draft opinion
Paragraph 2

2. Calls for a high level of human health protection to be ensured in the definition and implementation of all the Union’s policies and activities, as required by Article 168 of the Treaty on the Functioning of the European Union and Article 35 of the Charter of Fundamental Rights of the European Union;

Amendment 15 #

Draft opinion
Paragraph 2 a (new)

2a. Reiterates that the right to health is a human right recognised both in the Universal Declaration of Human Rights and in the International Covenant on Economic, Social and Cultural Rights and that this right concerns all Member States given that they have ratified international human rights treaties that recognise the right to health; points out that for this right to be guaranteed, access to medicine, among other factors, has to be ensured;

Amendment 16 #

Draft opinion
Paragraph 2 a (new)

2a. Points to the conclusions of the informal Council meeting of healthcare ministers held in Milan on 22 and 23 September 2014 during the Italian Council Presidency, at which many Member States agreed on the need to make joint efforts to facilitate the sharing of best practices and enable swifter access for patients;

Amendment 17 #

Draft opinion
Paragraph 2 a (new)

2a. Recalls that article 168/4 of the TFEU provides the EU with competences to guarantee that the authorisation of medicines shall ensure high standards of quality, safety and effectiveness. Considers that the European Commission shall develop the principles of safety and efficiency to improve access to high quality medicines in a safe and equitable way;

Amendment 18 #

Draft opinion
Paragraph 2 a (new)

2a. Strongly believes that Member States policies concerning healthcare systems and access to medicines should be designed and implemented to guarantee universal coverage, equality and the respect of the highest human rights standards, combatting the spread of the culture of profits' maximisation;

Amendment 19 #

Pál CSÁKY, Peter JAHR, Jarosław WAŁĘSA, Julia PITERA, György HÖLVÉNYI

Draft opinion
Paragraph 2 a (new)

2a. Welcomes that the Conclusions of the Council on strengthening the balance in the pharmaceutical system in the EU and its Members States outline the most relevant challenges of the pharmaceutical sector and important actions towards a fairer and a more patient-centred healthcare system;

Amendment 2 #

Pál CSÁKY, Peter JAHR, Jarosław WAŁĘSA, Julia PITERA

Draft opinion
Paragraph 1

1. Believes that the opinions of European citizens voiced by petitioning the European Parliament are fundamentally important in signalling to the European legislator issues that citizens feel concerned about, particularly ~~inadequate distribution of medicines, the impact of the economic crisis on medical and pharmaceutical care, and issues regarding marketing procedures and patents for medicinal products;~~ market failures resulting in restricted access to effective and affordable medicines, the impact of the economic crisis on patients' rights and Member States' healthcare systems, and issues regarding marketing procedures and intellectual property rights in the pharmaceutical sector;

Amendment 20 #

Draft opinion
Paragraph 2 b (new)

2b. Stresses that without full transparency of research and development costs to originator companies and information on the actual prices paid for medicines across EU Member States, any discussion on fair medicine prices remains highly problematic;

Amendment 21 #

Draft opinion
Paragraph 2 c (new)

2c. Underlines that Directive 89/105/EC on the transparency of measures regulating the pricing of medicinal products for human use and their inclusion in the scope of national health insurance systems no longer reflects the increased complexity of pricing and reimbursement procedures in the EU Member States;

Amendment 22 #

Draft opinion
Paragraph 2 d (new)

2d. Calls on the Commission to propose a new Directive to replace the Directive 89/105/EC on the transparency of measures regulating the pricing of medicinal products for human use and their inclusion in the scope of national health insurance systems with the aim of ensuring full transparency and effective controls of all procedures used to determine the prices and the reimbursement of medicinal products in the EU Member States;

Amendment 23 #

Draft opinion
Paragraph 2 e (new)

2e. Believes that a strategic breakthrough is needed in the area of disease prevention as it can be considered a key factor to reduce the use of medicines and guarantee at the same time a high level of human health protection; calls on the EU and Member States to reinforce legislation aimed at supporting a sustainable food production and to undertake all necessary initiatives to promote healthy and safe habits such as healthy nutrition;

Amendment 24 #

Draft opinion
Paragraph 3

3. Deplores the fact that there are 18 million people without access to health care or medicines, whose human rights are being violated on a daily basis; finds it alarming that there are 25 000 annual deaths in the EU due to lack of effective antibiotics, vaccines and treatments for rare diseases. Calls for a rethink of (to re- set) research priorities in order to respond to all health challenges. Calls for a review of the incentives put in place to encourage research on "orphan medicines" to see if they are successful, otherwise calls for new incentives;

Amendment 25 #

Draft opinion
Paragraph 3

3. Deplores the fact that there are 18 million people without access to health care or medicines, whose human rights are being violated on a daily basis; finds it alarming that there are 25 000 annual deaths in the EU due to lack of effective antibiotics and that many people die because they do not have access to or cannot pay the high cost of treatments such as the HIV/AIDS antiretroviral drugs or drugs to treat hepatitis C;

Amendment 26 #

Pál CSÁKY, Peter JAHR, Jarosław WAŁĘSA, Julia PITERA

Draft opinion
Paragraph 3

3. Deplores the fact that there is a large ~~18 million people~~number of EU citizens without proper access to health care or medicines, whose human rights are being ~~violated on a daily basis~~threatened; finds it alarming that there are ~~25 000 annual deaths in the EU~~thousands of victims due to lack of new effective antibiotics; and imprudent use of critical antibiotics;

Amendment 27 #

Draft opinion
Paragraph 3

3. Deplores the fact that there are 18 million people without access to health care or medicines, whose human rights are being violated on a daily basis; finds it intensely alarming that there are 25 000 annual deaths in the EU due to lack of effective antibiotics;

Amendment 28 #

Draft opinion
Paragraph 3 a (new)

3a. Calls on the Commission to effectively monitor and assess the implementation of the Directive 2011/24/EU on the application of patients' rights in cross-border healthcare in the EU Member States and to plan and carry out a formal evaluation of it that includes complaints, infringements and all transposition measures;

Amendment 29 #

Draft opinion
Paragraph 3 a (new)

3a. Voices its regret that the economic crisis and memorandum requirements in Greece, have led to drastic cuts in public spending on health care, including medical services and medicines;

Amendment 3 #

Draft opinion
Paragraph 1

1. Believes that the opinions of European citizens voiced by petitioning the European Parliament are of fundamentally importan~~t in signalling to the European legislator issues that citizens feel concerned about, particularly~~ce and should be addressed by the European legislator as a matter of priority; points to the issues raised by the public concerning the inadequate distribution of medicines, the impact of the economic crisis on medical and pharmaceutical care, ~~and~~ issues regarding marketing procedures and patents for medicinal products;

Amendment 30 #

Draft opinion
Paragraph 3 b (new)

3b. Calls on the EU Member States to fairly implement the Directive 2011/24/EU on the application of patients' rights in cross-border healthcare avoiding limitations to the application of the rules on reimbursement of cross-border healthcare, including the reimbursement of medicines, that could constitute a means of arbitrary discrimination or an unjustified obstacle to free movement;

Amendment 31 #

Draft opinion
Paragraph 4

4. Recognises as key obstacles to access to medicines the lack of affordability and availability of medicines, the budgetary cuts resulting from the financial crisis, the high price of medicines ~~and~~, the monopolies of large companies in the market and the impact of austerity measures on employment and the economy;

Amendment 32 #

Draft opinion
Paragraph 4

4. Recognises as key obstacles to access to medicines the lack of affordability and availability of medicines, the budgetary cuts resulting from the financial crisis, the fiscal adjustment programmes, the high price of medicines and the monopolies of large companies in the market;

Amendment 33 #

Pál CSÁKY, Peter JAHR, Jarosław WAŁĘSA, Julia PITERA, György HÖLVÉNYI

Draft opinion
Paragraph 4

4. Recognises ~~as key obstacles to access to medicines~~that the lack of affordability and availability of medicines, the ~~budgetary cuts resulting from~~impact of the financial crisis, the high price of medicines ~~and the~~resulting from monopolies of ~~large~~ companies in the market and the uncontrolled parallel trade constitute considerable obstacles to access to medicines;

Amendment 34 #

Draft opinion
Paragraph 4

4. Recognises as key obstacles to access to medicines the lack of affordability and availability of medicines, the ~~budgetary cuts resulting from the financial crisis, the high price of medicines and the monopolies of large companies in the market~~shortage of medicines and the lack of research on certain diseases;

Amendment 35 #

Draft opinion
Paragraph 4 a (new)

4a. Recalls that in its reply to Petition No 2128/2014 where the petitioner demands the EU to adopt a directive allowing governments to impose compulsory licences and royalty levels on pharmaceutical patents when the general or public interest is at stake, the Commission states that it "has no plans to harmonise this field, given that many Member States, including Spain, already have provisions in national law for compulsory licensing";

Amendment 36 #

Draft opinion
Paragraph 4 a (new)

4a. Calls on the Commission and Member States to adequately tackle all problems related to parallel trade in medicines in the EU adopting measures based on the highest human rights standards in order to guarantee full availability and accessibility for all medicines, with particular attention to those needed for serious diseases such as, inter alia, hepatitis C;

Amendment 37 #

Draft opinion
Paragraph 4 b (new)

4b. Recognises the current market failure to produce medicines patients need, as pointed out in Petition No 2128/2014 where "the petitioner regrets that the medicine Reandron, used by transgenders and patients that were operated for testicular cancer to increase their testosterone levels, was withdrawn from the Spanish market by its exclusive producer, Bayer. Indeed, following the order of the Ministry of Health to decrease its price by 35% to be reimbursed, Bayer estimated it was not profitable anymore. Even though the Ministry assured there are alternatives to this medicine, these alternative are less efficient and require more numerous injections (whereas the Reandron only needs to be injected every three or four months). Thus, it forces the patients to be more dependent on the healthcare, and creates a new burden on the social security system."

Amendment 38 #

Draft opinion
Paragraph 4 b (new)

4b. Urges the Commission to improve the collection of readily and standardised data and statistics concerning access to medicines for EU citizens, in particular focusing on all issues encountered by the most vulnerable and disadvantaged social groups;

Amendment 39 #

Draft opinion
Paragraph 4 c (new)

4c. Recalls the detrimentally high level of public dependency on the will of the private companies to develop life- saving products, as highlighted in Petition n° 0791/2009, where the Commission recalls in its reply that "the pharmaceutical legislation of the EU foresees specific instruments as incentives for the development of innovative medicines, in particular data exclusivity for specific studies, or market exclusivity for certain medicinal products for rare diseases. Within this legal framework, pharmaceutical companies are free to choose which medicinal products they want to develop."

Amendment 4 #

Draft opinion
Paragraph 1

Amendment 40 #

Draft opinion
Paragraph 4 c (new)

4c. Stresses that some Member States should cut the unnecessary red tape with the purpose to reduce the existing differences in the waiting times for the availability of medicines in the EU, making sure in any case that the highest level of human health protection is safeguarded;

Amendment 41 #

Draft opinion
Paragraph 5

5. Highlights the negative impact of ~~5. Member States’ austerity policies and~~austerity policies in the Member States that are urged by the EU and enforced by its policies monitoring Member States’ economies through the European Semester and which promote cuts in public investment and entail debt payment being given priority over all other items in national budgets; stresses that budgetary cuts should not prevent any EU citizen or resident thereof, nor any migrant or asylum seeker, from being able to access medicines;

Amendment 42 #

Draft opinion
Paragraph 5

5. Highlights the negative impact of Member States’ austerity policies and stresses that budgetary cuts should not prevent any EU citizen from being able to access medicines; calls particularly on the Council to consider adopting extraordinary measures and joint cooperation initiatives to remove the differences that exist between countries in terms of purchasing power when accessing medicines;

Amendment 43 #

Draft opinion
Paragraph 5

5. Highlights the negative impact of Member States’' austerity policies ~~and stresses that budgetary cuts should not prevent any EU citizen~~particularly as they hit the poorest, sickest and least healthy regions of the EU hardest, stresses that budgetary cuts invariably have negative health impacts on citizens therefore action is needed to ensure that no EU citizen is prevented from being able to access medicines;

Amendment 44 #

Pál CSÁKY, Peter JAHR, Jarosław WAŁĘSA, Julia PITERA

Draft opinion
Paragraph 5

5. ~~Highlights the negative impact of Member States’ austerity policies and s~~Stresses that budgetary cuts should not prevent any EU citizen from being able to access medicines;

Amendment 45 #

Draft opinion
Paragraph 5

5. ~~Highlights the negative impact of Member States’ austerity policies and stresses that~~Stresses that Member States budgetary cuts should not prevent any EU citizen from being able to access medicines;

Amendment 46 #

Draft opinion
Paragraph 5

5. Highlights the negative impact of ~~Member States’~~the austerity policies inflicted on the Member States and stresses that budgetary cuts should not prevent any EU citizen from being able to access medicines;

Amendment 47 #

Draft opinion
Paragraph 5

5. ~~Highlight~~Emphasises the negative impact of ~~Member States’~~the austerity policies imposed by Member States and stresses that budgetary cuts should not prevent any EU citizen from being able to access medicines;

Amendment 48 #

Draft opinion
Paragraph 5 a (new)

5a. Deplores that while the European Semester thematic analysis on health and health systems 2016 1a identifies that "the most common barriers for access to healthcare resulted from patients' inability and/or unwillingness to pay medical goods and services, while in some countries waiting times or travelling distance were an issue healthcare could also be constrained by insufficient availability of healthcare infrastructure and health workforce", it does not include any explicit recommendation on lowering the prices of medicines and strengthening the budgets for staff and infrastructure; __________________ 1a http://ec.europa.eu/europe2020/pdf/theme s/2016/health_health_systems_201605.pdf

Amendment 49 #

Pál CSÁKY, Peter JAHR, Jarosław WAŁĘSA, Julia PITERA

Draft opinion
Paragraph 5 a (new)

5a. Calls on the Commission to continue assessing the functioning of the European pharmaceutical system in order to deliver data and proposals for solutions to ensure the sustainability of the European pharmaceutical system and Member States' health systems, as well as the developments of new and innovative medicinal products;

Amendment 5 #

Draft opinion
Paragraph 1 – point 1 (new)

(1) Calls on the Commission to make specific policy proposals and changes to EU legislation on intellectual policy in order to step up EU competitiveness in regard to medicines through EU- manufactured or imported generic, affordable versions thereof;

Amendment 50 #

Draft opinion
Paragraph 5 a (new)

5a. Notes that austerity is undermining citizens right to health in Europe, notably by Member States contravening the principle of non- regression with regards to their own health care policies and funding of health care systems;

Amendment 51 #

Draft opinion
Paragraph 5 a (new)

5a. Calls urgently for fresh political impetus for the adoption of the Directive on Transparency in the Prices of Medicinal Products, which is still blocked pending a decision in the Council;

Amendment 52 #

Draft opinion
Paragraph 5 a (new)

5a. Underlines the adverse impact of the policy adopted by the Troika seeking to change the Greek health service;

Amendment 53 #

Draft opinion
Paragraph 5 b (new)

5b. Calls on the Commission to consider resolving the difficulties regarding access to medicines by adopting a uniform price in Europe, in order to avoid disparities being created between the various markets;

Amendment 54 #

Pál CSÁKY, Peter JAHR, Jarosław WAŁĘSA, Julia PITERA

Draft opinion
Paragraph 5 b (new)

5b. Supports the intention of the Member States to improve the voluntary cooperation between the states and at EU level, especially in the area of pricing, reimbursements and information exchange;

Amendment 55 #

Draft opinion
Paragraph 5 c (new)

5c. Calls on the EU institutions and Member States to take the utmost care to prevent the parallel trade in pharmaceutical products in the most profitable markets, which is causing quotas to be established and a consequent shortage of many medicines, and thus creates extreme risks for the health of citizens, who in some cases are even forced to discontinue treatment;

Amendment 56 #

Draft opinion
Paragraph 6

6. Recognises the launch of the United Nations High-Level Panel on Access to Medicines as a ~~global response to the need to~~step towards addressing multifaceted issues in a holistic way;

Amendment 57 #

Draft opinion
Paragraph 6 a (new)

6a. Recalls that EU citizens finance at least 50% of the European pharmaceutical innovation through the public participation in the Innovative Medicines Initiative (IMI), which for the moment contains no provision for unpatentability of the results of publicly funded research 1a; __________________ 1a https://www.imi.europa.eu/content/intellec tual-property-policy

Amendment 58 #

Pál CSÁKY, Peter JAHR, Jarosław WAŁĘSA, Julia PITERA, György HÖLVÉNYI

Draft opinion
Paragraph 7

7. ~~Identifies~~Notes that patent rights a~~s a major~~nd other innovation promotion measures often create obstacles to access to medicines, and urges public policy makers to take proactive steps towards making generic and biosimilar medicines available in a timely manner, always taking into account the need to ensure the same beneficial effects, continuity of patient care and prevention of any risk of abuse or misuse of the regulatory framework;

Amendment 59 #

Draft opinion
Paragraph 7

7. ~~Identifies patent rights as a major obstacle to access to medicines, and u~~Urges public policy makers to take proactive steps towards making generic and biosimilar medicines available, always taking into account the need to ensure the same beneficial effects, continuity of patient care and prevention of any risk of abuse or misuse of the regulatory framework;

Amendment 6 #

Draft opinion
Paragraph 1 – point 2 (new)

(2) Insists on the need for greater transparency concerning the cost of investment in pharmaceutical research, development and innovation, so as to know how much public money is invested in each research project and ensure that in the last analysis the public does not pay twice for the same product; urges the adoption of the measures needed to arrive at a model that will guarantee a return on this investment for public health services;

Amendment 60 #

Draft opinion
Paragraph 7

7. ~~Identifies patent rights as a major obstac~~Recognises the need to review patenting rules to improve access to medicines and incentivise research, and urges public policy makers to take proactive steps towards making generic and biosimilar medicines available, always taking into account the need to ensure the same beneficial effects, continuity of patient care and prevention of any risk of abuse or misuse of the regulatory framework;

Amendment 61 #

Draft opinion
Paragraph 7

7. Identifies patent rights as a major obstacle to access to medicines, and urges public policy makers to take proactive steps towards making ~~generic and~~ biosimilar medicines available, always taking into account the need to ensure the same beneficial effects, continuity of patient care and prevention of any risk of abuse or misuse of the regulatory framework;

Amendment 62 #

Draft opinion
Paragraph 7 a (new)

7a. Also asks the authorities to accept and facilitate reimbursement for natural and efficacious treatments based, for instance, on natural medicines or homeopathy in order to broaden the range of therapies on offer and develop alternatives to conventional medicine approaches;

Amendment 63 #

Draft opinion
Paragraph 7 a (new)

7a. Demands the urgent adoption of new formulas for public patents that would avoid the disproportionate profits made currently by the pharmaceutical industry, such as an EU and worldwide renegotiation of access to medicines, which would include the possibility of mandatory licences;

Amendment 64 #

Draft opinion
Paragraph 7 a (new)

7a. Notes that Member States should enhance measures aimed at avoiding any conflicts of interest between producers and prescribers of medicines;

Amendment 65 #

Draft opinion
Paragraph 7 b (new)

7b. Calls for an investigation to be opened into whether the high prices for new hepatitis C drugs are in breach of EU procurement law;

Amendment 66 #

Draft opinion
Paragraph 7 c (new)

7c. Demands greater transparency in regard to public procurement prices for medicines and proposes that a central purchasing body be established at EU level;

Amendment 67 #

Pál CSÁKY, Peter JAHR, Jarosław WAŁĘSA, Julia PITERA, György HÖLVÉNYI

Draft opinion
Paragraph 8

8. Calls on the Member States to support research and development (R&D) that focuses on the unmet medical needs of all citizens and to guarantee affordable and non-discriminatory access to medical advances in the European Union; emphasizes the importance of further investments through the Horizon2020 and the Innovative Medicines Initiative, as well as the involvement of the European Medicines Agency in the development of innovative medicines;

Amendment 68 #

Draft opinion
Paragraph 8

8. Calls on the Member States to support research and development (R&D) that focuses on the medical needs of all citizens and to guarantee affordable ~~and non-discriminatory~~pricing for citizens, guarantees non-exclusive licensing where R&D is largely publicly funded, and that access to medical advances in the European Union is non- discriminatory;

Amendment 69 #

Draft opinion
Paragraph 8

8. Calls on the Member States to support research and development (R&D) that focuses on the medical needs of all citizens and to guarantee affordable and non-discriminatory access to medical advances in the European Union; Calls on the Member States to make eHealth tools more effective, user/friendly and widely accepted;

Amendment 7 #

Demetris PAPADAKIS, Soledad CABEZÓN RUIZ, Jude KIRTON-DARLING

Draft opinion
Paragraph 1 – point 3 (new)

(3) Highlights the importance of establishing alternative formulas to make it easier to obtain certain medicines; considers that an EU central purchasing body for medicines needs to be set up so as to obtain more competitive prices by profiting from the advantages offered by economies of scale;

Amendment 70 #

Draft opinion
Paragraph 8 – subparagraph 1 (new)

Underlines the importance of information-sharing and cooperation between Member States on pricing, reimbursement and procurement policies, as well as cooperation between stakeholders in order to facilitate better balancing of the value of innovation with equitable, affordable patient access.

Amendment 71 #

Draft opinion
Paragraph 8 – point 1 (new)

(1) Points to the issue of online sales of counterfeit medicines, which poses a grave threat to the health and safety of EU citizens;

Amendment 72 #

Draft opinion
Paragraph 8 a (new)

8a. Calls for a new Transparency Directive following the withdrawal of Directive 89/105/EEC, which aims to ensure the measures established by EU countries to control the pricing and reimbursement of medicinal products are transparent; and ensures that the cost of production of medicines is transparent;

Amendment 73 #

Draft opinion
Paragraph 8 a (new)

8a. Calls on Member States to enhance the protection of life and health by obliging pharmacies to provide consumers with information leaflets on medicines in all most widely used languages of a particular country or region in addition to official language or languages;

Amendment 74 #

Draft opinion
Paragraph 8 b (new)

8b. Calls on the European Commission to promote measures to stimulate the uptake of generic medicines, which can effectively lower costs and reduce overall expenditure on medicines;

Amendment 75 #

Draft opinion
Paragraph 8 c (new)

8c. Calls on member states to investigate the benefits of potential cooperation of lower costs of medicines for citizens via joint purchasing mechanisms;

Amendment 76 #

Draft opinion
Paragraph 8 d (new)

8d. Calls on the European Commission to develop a European framework, to provide reliable, timely and transparent, comparable and transferable information on the relative efficacy of health technologies to support Member States' decisions;

Amendment 77 #

Draft opinion
Paragraph 9

Amendment 78 #

Jarosław WAŁĘSA

Draft opinion
Paragraph 9

Amendment 79 #

Jude KIRTON-DARLING

Draft opinion
Paragraph 9

9. Underlines that free trade agreements such as TTIP and TiSA may seriously damage Member States’ healthcare systems, paving the way for wider liberalisation and privatisation in vital sectors and further undermining the principle of universal access to healthcare; therefore reiterates the European Parliament's call for a full carve out for services of general economic interest including healthcare; from their scope of application;

Amendment 8 #

Draft opinion
Paragraph 1 – point 4 (new)

(4) Calls for the adoption of EU standards for public transparency as regards the prices involved in the public procurement of medicines;

Amendment 80 #

Draft opinion
Paragraph 9

9. Underlines that free trade agreements such as TTIP and TiSA ~~may~~will seriously ~~damag~~jeopardise Member States’ healthcare systems~~, paving the way for wider liberalisation and privatisation in vital sectors and further undermining the principle of universal access to healthcare~~;

Amendment 81 #

Pál CSÁKY, Peter JAHR, Julia PITERA

Draft opinion
Paragraph 9

9. Underlines that ~~free trade agreements such as TTIP and TiSA may seriously damage Member States’ healthcare systems, paving the way for wider liberalisation and privatisation in vital sectors and further undermining~~ the principle of universal access to healthcare should be respected also by trade agreements;

Amendment 82 #

Draft opinion
Paragraph 9

9. Underlines that free trade agreements such as TTIP and TiSA may seriously damage Member States’ healthcare systems, paving the way for wider liberalisation and privatisation in vital sectors and further undermining the principle of universal access to healthcarethe report refers to the medicine policy in the EU, but must ensure that future international trade agreements do not undermine access to medicines;

Amendment 83 #

Draft opinion
Paragraph 9

9. ~~Underlines that free trade agreements such as TTIP and TiSA may seriously damage Member States’ healthcare systems, paving the way for wider liberalisation and privatisation in vital sect~~Calls on the Commission to monitor the impact of trade agreements such as TTIP and TiSA allowing not only for an ex-ante but also fors an~~d further undermining the principle of universal access to~~ ex-post evaluation of Member States' healthcare systems;

Amendment 84 #

Draft opinion
Paragraph 9

9. Underlines that free trade agreements such as TTIP, CETA and TiSA may seriously damage Member States’ healthcare systems, paving the way for wider liberalisation and privatisation in vital sectors and further undermining the principle of universal access to healthcare;

Amendment 85 #

Draft opinion
Paragraph 10

10. Calls on the ~~Member States~~Commission to establish a pooled public platform for R&D financed by all sMember States via a contribution of 0.01 % of their GDP. Considers that this platform should also be able to directly produce life-saving medicines in the EU in case a market failure has been identified.

Amendment 86 #

Draft opinion
Paragraph 10

10. Calls on the Member States to establish a pooled public platform for R&D ~~financed by all states via a contribution of 0.01% of their GDP.~~;

Amendment 87 #

Draft opinion
Paragraph 10

10. ~~Call~~Recommends on the Member States to ~~establish a pooled public platform for R&D financed by all states via a contribution of 0.01 % of their GDP~~develop healthcare reforms in according to their widely assessed healthcare policy in order to ensure better access to health care and medicines for people.

Amendment 88 #

Draft opinion
Paragraph 10

10. Calls on the Member States to establish a pooled public platform for R&D financed by all states ~~via a contribution of 0.01 % of their GDP~~.

Amendment 89 #

Pál CSÁKY, Peter JAHR, Jarosław WAŁĘSA, Julia PITERA

Draft opinion
Paragraph 10

10. ~~Calls on~~Invites the Member States to consider the possibility of establishment of a pooled public platform for R&D ~~financed by all states via a contribution of 0.01 % of their GDP~~.

Amendment 9 #

Draft opinion
Paragraph 1 – point 5 (new)

(5) Calls for an incentive to be provided under the Horizon 2020 programme to produce certain medicines that can be placed on the EU market as generic medicines at a price affordable for the majority of European patients under a socially responsible intellectual property licence;

Amendment 90 #

Draft opinion
Paragraph 10

10. Calls on the Member States to establish a pooled public platform for R&D financed by all states via a minimum contribution of 0.01 % of their GDP.

Amendment 91 #

Draft opinion
Paragraph 10

10. Calls on the Member States to establish a pooled public platform for R&D financed ~~by all states~~ via a contribution ~~of 0.01 % of their GDP~~by all pharmaceutical companies.

Amendment 92 #

Draft opinion
Paragraph 10 a (new)

10а. Emphasises that the Union has competence for taking action to support, coordinate and supplement the actions of the Member States to protect and improve human health; Union action must respect the responsibilities of the Member States for the definition of their health policy and for the organisation and delivery of health services and medical care.

Amendment 93 #

Draft opinion
Paragraph 10 a (new)

10a. Recognizes the value of citizens' initiatives such as the European Charter of Patients' Rights, based on the Charter of Fundamental Rights of the European Union, and the European Patients' Rights Day celebrated every year on 18 April at local and national level in the EU Member States; invites the Commission to institutionalise the European Patients' Rights Day at EU level;

Amendment 94 #

Draft opinion
Paragraph 10 a (new)

10a. Calls on the Commission, in close cooperation with the Member States, to promote information-sharing, participation and coordination in medicine policy, in particular on pricing, reimbursement and procurement policies.

Amendment 95 #

Draft opinion
Paragraph 10 a (new)

10a. Calls for an emergency health recovery fund to be set up at EU level for people in the EU Member States who are suffering from pathologies such as hepatitis C or HIV/AIDS;

Amendment 96 #

Draft opinion
Paragraph 10 b (new)

10b. Urges the establishment of a plan to study and collect data on the prevalence of hepatitis C in the EU, and to promote action in research, funding and recommendations that will enable an early diagnosis thereof at EU level; calls for action in research, funding and recommendations that will ensure early diagnosis, as well as for standards to be adopted and good practices exchanged in the Member States;

Amendment 97 #

Draft opinion
Paragraph 10 c (new)

10c. Proposes that a parliamentary working party be set up to examine the research and development costs of medicines, and their sale price;

source: 582.218

2016/09/07 EMPL 85 amendments...

Amendment 1 #

Draft opinion
Recital A

~~A. whereas guaranteeing universal access to medicines presents a myriad of challenges;~~deleted

Amendment 10 #

Draft opinion
Recital B

B. whereas people living with disabilities ~~are the most vulnerable and need medicines the most~~for which there is no treatment/drug yet or people living with rare disabilities are in a particularly parlous position;

Amendment 11 #

Draft opinion
Recital Β

Β. whereas people living with disabilities are the most vulnerable and are in great need of medicines ~~the most~~;

Amendment 12 #

Draft opinion
Recital B

B. whereas ~~people living with disabilities are the most vulnerable and need medicines the most~~it is those who are the most vulnerable that have the greatest difficulty in accessing medicines;

Amendment 13 #

Draft opinion
Recital C

~~C. whereas the EU will need to oversee improvements in a range of fields that have an impact on how medicines are produced and distributed;~~deleted

Amendment 14 #

Draft opinion
Recital C

~~C. whereas EU decisions will be conditioned by measures to achieve improvements in a range of fields that have an impact on how medicines are produced and distributed;~~deleted

Amendment 15 #

Draft opinion
Recital C

C. whereas the EU will need to oversee improvements in a range of fields that have an impact on how medicines are produced and distributed as well as ensuring the right of patients to all relevant information;

Amendment 16 #

Draft opinion
Recital C

C. whereas the EU will need to oversee improvements in a range of fields that have an impact on how medicines are produced and distributed; calls on the Member States to support research and development (R&D) that focuses on the medical needs of all citizens, through ensuring that the structure for funding the research, development and commercialisation of new medicines is redirected towards the public good and to guarantee affordable and non- discriminatory access to medical advances, examining options such as bulk buying, risk sharing, and state funding of R&D; also calls on Member States to particularly focus on R&D to tackle antimicrobial resistance;

Amendment 17 #

Draft opinion
Recital C a (new)

Ca. whereas the Member States all have different basic set-ups for their social security systems and for funding them, and whereas this opinion has no bearing on them;

Amendment 18 #

Draft opinion
Recital C b (new)

Cb. whereas access to drugs, under certain conditions, can be considered to be of general economic interest within the meaning of Article 106(2) TFEU; whereas Treaty rules, in particular competition rules, can accordingly be disapplied in so far as is necessary to achieve the objective pursued;

Amendment 19 #

Draft opinion
Paragraph 1

1. Stresses the importance ~~of observing the principle of subsidiarity, as each Member State must address any shortcomings on the basis of its own particular requirements~~for each Member State to ensure accessibility of pharmacies, including their density in both urban and rural areas, professional staff number, appropriate opening hours, qualitative advice and counselling service;

Amendment 2 #

Draft opinion
Recital A

~~A. whereas guaranteeing universal access to medicines presents a myriad of challenges;~~deleted

Amendment 20 #

Draft opinion
Paragraph 1

1. Stresses the importance of observing the principle of subsidiarity~~, as each Member State must address any shortcom~~; takes the view, however, that better access to medicinges ~~on the basis of its own particular requirement~~can be achieved through better cooperation between Member States;

Amendment 21 #

Draft opinion
Paragraph 1

1. Stresses ~~the~~how importan~~ce of observing~~t it is that, in keeping with the principle of subsidiarity, as each Member State ~~must~~should address any shortcomings on the basis of its own particular requirements, by optimising the targeting and use of the instruments at its disposal and seeking - above all as regards drugs used to treat rare diseases - to reduce the current substantial differences in cost;

Amendment 22 #

Draft opinion
Paragraph 1

1. Stresses the importance of observing the principle of subsidiarity and proportionality, as each Member State must address any shortcomings on the basis of its own particular requirements; points out that the financial adjustments arbitrarily imposed by the Troika in the Memorandum countries, especially Greece, are making it impossible to address these shortcomings since, as a result of health cuts, medicines are now in woefully short supply;

Amendment 23 #

Draft opinion
Paragraph 1

1. Stresses the importance of observing the principle of subsidiarity, as each Member State must address any shortcomings on the basis of its own particular requirements, strictly adhering to the terms of Article 35 (health care) of the Charter of Fundamental Rights of the EU, regardless of financial indicators;

Amendment 24 #

Draft opinion
Paragraph 1

1. Stresses th~~e importance of observing the principle of subsidiarity, as~~at each Member State must ensure that it addresses any shortcomings on the basis of its own particular requirements;

Amendment 25 #

Laura AGEA, Tiziana BEGHIN, Daniela AIUTO, Piernicola PEDICINI

Draft opinion
Paragraph 1

1. Stresses the importance of observing the principle of subsidiarity, as each Member State must manage its own resources and address any shortcomings on the basis of its own particular requirements;

Amendment 26 #

Draft opinion
Paragraph 1 a (new)

1a. Regards universal access to medicines as essential, all the more so because the economic crisis in Europe has made such access even more of a problem, in particular for the most vulnerable groups in society; urges, therefore, that these groups should be guaranteed access to medicines;

Amendment 27 #

Arne GERICKE

Draft opinion
Paragraph 1 a (new)

1a. Looks to the Member States to establish arrangements making use of the EU internal market with regard to medicines, too, and facilitating patient access throughout Europe to equivalent and, in all cases, the most cost-effective medicines;

Amendment 28 #

Draft opinion
Paragraph 1 a (new)

1a. Calls for EU incentives so as to prompt governments to negotiate jointly with pharmaceuticals - instead of each going it alone - in order to arrive at better prices;

Amendment 29 #

Draft opinion
Paragraph 2

2. Calls for support for the progress achieved by the pharmaceutical industry, hitherto driven by European SMEs, which have transformed the standard of healthcare in Europe and helped to prolong life expectancy;deleted

Amendment 3 #

Draft opinion
Recital A

A. whereas guaranteeing universal access to medicines presents a m~~yriad of~~any challenges but nonetheless must be our common goal;

Amendment 30 #

Romana TOMC

Draft opinion
Paragraph 2

2. ~~Calls for support for the progress achieved by the pharmaceutical industry, hitherto driven by European SMEs, which have~~Stresses the importance of SMEs in transformeding the standard of healthcare in Europe and ~~helped to prolong life expectancy~~calls for further support for their development;

Amendment 31 #

Draft opinion
Paragraph 2

2. Calls for ~~support for the progress achieved by the pharmaceutical industry, hitherto driven by Europe~~backing to be given to European research projects and SMEs~~, which have transformed the standard of healthcare in Europe and helped to prolong life expectancy~~ in order to improve the supply of essential medicines in Europe;

Amendment 32 #

Draft opinion
Paragraph 2

2. Calls for support for the research carried out and the progress achieved by the pharmaceutical industry, hitherto driven by European SMEs, which have transformed the standard of healthcare in Europe and helped to prolong life expectancy;

Amendment 33 #

Draft opinion
Paragraph 2

2. Calls for support for the progress achieved by the pharmaceutical industry, especially the progress hitherto driven by European SMEs, which have transformed the standard of healthcare in Europe and helped to prolong life expectancy;

Amendment 34 #

Draft opinion
Paragraph 2

2. Calls for support for the progress achieved by the pharmaceutical industry, hitherto driven by European SMEs too, which have transformed the standard of healthcare in Europe and helped to prolong life expectancy;

Amendment 35 #

Draft opinion
Paragraph 2

Amendment 36 #

Draft opinion
Paragraph 2 a (new)

2a. Deplores the fact that there are 18 million people across the EU without access to health care; finds it unacceptable that there are 25 000 annual deaths in the EU due to lack of effective antibiotics; also finds it alarming that in a period of prosperity with many advances in healthcare, medicines and technology, there appears to be very little advancement in creating sustainable solutions for those without healthcare or medicines;

Amendment 37 #

Draft opinion
Paragraph 2 a (new)

2a. Emphasises that for the protection of health and life and in the interests of consumer protection information notes accompanying medicines might be provided by retailers in widely used languages of a particular Member State in addition to official language or languages;

Amendment 38 #

Arne GERICKE

Draft opinion
Paragraph 2 a (new)

2a. Stresses the need for access to suitable medicines for children and young people and for research and development in this connection;

Amendment 39 #

Romana TOMC

Draft opinion
Paragraph 2 a (new)

2a. Stresses that everyone should have access to medicines, regardless of their social position;

Amendment 4 #

Draft opinion
Recital Α

Α. whereas ~~guaranteeing~~ universal access to medicines ~~presents a myriad of challenges~~is an indefeasible right;

Amendment 40 #

Draft opinion
Paragraph 3

~~3. Recommends that each Member State should be free to set its own innovation policy in the field of cutting- edge technologies, possibly with the aid of EU funding;~~deleted

Amendment 41 #

Draft opinion
Paragraph 3

~~3. Recommends that each Member State should be free to set its own innovation policy in the field of cutting- edge technologies, possibly with the aid of EU funding;~~deleted

Amendment 42 #

Romana TOMC

Draft opinion
Paragraph 3

3. ~~Recommend~~Stresses that hea~~ch Member State should be free to set its own innovation policy in the field of cutting- edge technologies, possibly with the aid of EU funding~~lthy competition should also be guaranteed in the area of access to medicines, so as to make possible lower prices and higher quality of services for users;

Amendment 43 #

Draft opinion
Paragraph 3

3. ~~Recommends that each Member State should be free to set its own innovation policy in the field of cutting- edge technologies, possibly with the aid of EU funding~~Points out that innovation policy is conducted at Member State level; underlines the importance nonetheless of the EU's supportive and coordinating role; strongly believes that international cooperation and information sharing should be encouraged;

Amendment 44 #

Draft opinion
Paragraph 3

3. ~~Recommends that each Member State should be free to set its own innovation policy in the field of cutting- edge technologies, possibly with the aid of EU funding~~Believes that co-operation between Member States along with the sharing of expertise, leads to greater synergy in the field of innovation policy and recognises the importance of EU funding in supporting such initiatives;

Amendment 45 #

Draft opinion
Paragraph 3

3. Recommends that each Member State should be free to invest and set its own innovation policy in the field of cutting- edge technologies~~, possibly~~ for disease prevention and public health and well- being, in part with the aid of EU funding;

Amendment 46 #

Csaba SÓGOR

Draft opinion
Paragraph 3

3. Recommends that each Member State should be ~~free~~encouraged to set ~~its own~~up innovation ~~policy in the field of~~and cutting- edge technolog~~ies, possibly with the aid of EU funding~~y policies, including in the field of medicines, and to make the best use of available EU funding in this area;

Amendment 47 #

Draft opinion
Paragraph 3

3. Recommends that each Member State should be free to set its own innovation policy in the field of cutting- edge technologies~~, possibly with the aid of~~ by stepping up EU funding;

Amendment 48 #

Draft opinion
Paragraph 3

3. Recommends that each Member State should ~~be free to set~~develop its own innovation policy in the field of cutting- edge technologies, possibly with the aid of EU funding;

Amendment 49 #

Draft opinion
Paragraph 3 a (new)

3a. Takes the view that the development of an international tool for assessing the efficiency/effectiveness of medicines would be a major advance; calls on the EU to promote the importance of scientific evidence that is freed of all political considerations;

Amendment 5 #

Laura AGEA, Tiziana BEGHIN, Daniela AIUTO, Piernicola PEDICINI

Draft opinion
Recital A

A. whereas guaranteeing universal access to medicines presents a myriad of pressing challenges which must have priority;

Amendment 50 #

Draft opinion
Paragraph 3 a (new)

3a. Urges that access to medicines should be guaranteed for people in all countries, not just in those with effective innovation policies; points out that innovation does not always serve to ensure that medicines are more readily available, and indeed may have the opposite effect;

Amendment 51 #

Draft opinion
Paragraph 3 a (new)

3a. Recommends that EU health research programmes should ensure greater knowledge sharing and that the rules for participating in EU research programmes could include possible mandatory conditions for licencing that preserve public policy objectives;

Amendment 52 #

Draft opinion
Paragraph 4

4. Recommends that information sharing ~~and~~, the training of medical professionals ~~be made an immediate priority~~and exchanges of best practice be made an immediate priority with a view to bringing about a gradual but decisive improvement in the provision of healthcare, and emphasises that the development of the instruments which new technologies are now making available in the areas of research, ease of access to patients, also in their own homes, and the sharing of information could play a key role in facilitating the provision of healthcare;

Amendment 53 #

Draft opinion
Paragraph 4

4. ~~Recommends~~Points out that information sharing and ~~the~~high-quality training ofor medical professionals ~~be made~~is an immediate priority; stresses that it is also very important to 'train' patients as regards prevention and get them to take that on board;

Amendment 54 #

Draft opinion
Paragraph 4

4. Recommends that information sharing a~~nd the~~t European level and high-quality training ofor medical professionals be made an immediate priority;

Amendment 55 #

Draft opinion
Paragraph 4

4. Recommends that information sharing and the training of medical professionals and researchers be made an immediate priority;

Amendment 56 #

Draft opinion
Paragraph 4

4. Recommends that information sharing and the training of medical professionals be made an immediate priority, particularly regarding the prevention of incurable diseases and cancer;

Amendment 57 #

Draft opinion
Paragraph 4

4. Recommends that information sharing and the training of medical professionals be made an immediate priority; highlights the negative impact that Member States' austerity policies and budgetary cuts have had on citizens access to healthcare and access to medicines; condemns the situation which has been fostered in healthcare systems whereby the value of a life is equated to wealth, whereby those who are financially better off can get quicker and better treatment than those lesser off;

Amendment 58 #

Arne GERICKE

Draft opinion
Paragraph 4 a (new)

4a. Stresses the importance of comprehensive medicines supply in rural areas, too, and the attendant need to maintain small-scale family-run or owner-managed pharmacies;

Amendment 59 #

Draft opinion
Paragraph 5

5. ~~Urges~~Points out that prevention, health and well-being are fundamental rights and key principles underpinning a social Europe; urges, therefore, that there should be no inequality or discrimination as regards innovation and the provision of healthcare and that universal access to medicines should not be contingent on price, which should reflect a fair balance between the cost of research, industry growth and the need for sustainable welfare systems;

Amendment 6 #

Draft opinion
Recital Α

Α. whereas guaranteeing universal access to medicines presents a myriad of challenges; whereas Article 34 (social security and social assistance) of the Charter of Fundamental Rights of the European Union categorically prohibits exclusion from access to medicines;

Amendment 60 #

Draft opinion
Paragraph 5

5. ~~Urg~~Stresses that ~~universal access to medicines should not be contingent on price, which should reflect a fair balance~~a fair balance must be sought between the cost of research, industry growth and ~~the need for~~ sustainable welfare systems;

Amendment 61 #

Draft opinion
Paragraph 5

5. ~~Urges that universal access to medicines should not be contingent on price, which~~Points out that the cost of medicines should reflect a ~~fair~~ balance between the cost of research, industry growth and the need for sustainable welfare systems; urges that universal access to medicines should not be contingent on price;

Amendment 62 #

Laura AGEA, Tiziana BEGHIN, Daniela AIUTO, Piernicola PEDICINI

Draft opinion
Paragraph 5

5. ~~Urges that~~Calls for universal access to medicines ~~should not be contingent on price, which should reflect a fair balance between the cost of~~and increased funding for investment in research, industry growth and the need for sustainable welfare systems;

Amendment 63 #

Draft opinion
Paragraph 5

5. Urges that universal access to medicines should not be contingent on price, which should reflect a fair balance between the cost of research, industry growth and the need for sustainable welfare systems; urges that a balance should be maintained at all times between research, development and sustainability, with a view to combating the pharmaceutical oligopolies which determine the price of medicines, even when the prices in question are unsustainable for many health systems, and in so doing create vast areas in which people are denied access to medicines;

Amendment 64 #

Draft opinion
Paragraph 5

5. Urges that universal access to medicines should not be contingent on price, which should reflect a fair balance between the cost of research, industry growth and the need for sustainable welfare systems; sees patent rights as an obstacle to access to medicines, and urges public policy makers to take definitive steps towards addressing issues arising around patent rights; calls for greater transparency in public procurement prices for medicines;

Amendment 65 #

Draft opinion
Paragraph 5

Amendment 66 #

Draft opinion
Paragraph 5 a (new)

5a. Recommends that a medicine price negotiation mechanism be devised to ensure greater uniformity at EU level, especially in those cases where the cost of the labour is incompatible with Member States’ welfare systems;

Amendment 67 #

Csaba SÓGOR

Draft opinion
Paragraph 6

Amendment 68 #

Draft opinion
Paragraph 6

Amendment 69 #

Draft opinion
Paragraph 6

6. Reiterates that the stability of European welfare systems, which are one of the cornerstones of EU cooperation and whose budgets differ greatly from one Member State to another, is contingent on people being in employment, and that high levels of unemployment are making it essential to find new means of funding welfareTakes the view that welfare systems must not be contingent solely on people being in employment, but, rather, that they must be funded from other revenue sources;

Amendment 7 #

Draft opinion
Recital A a (new)

Aa. Calls for universal access to quality healthcare in Member States; believes this to be a fundamental right of European citizens; further believes this to be the only way to ensure equality in healthcare for citizens in all European Union Member States.

Amendment 70 #

Draft opinion
Paragraph 6

6. Reiterates that the stability of European welfare systems, which are one of the cornerstones of EU cooperation ~~and whose budgets differ greatly from one Member State to another, is contingent on people being in employment, and that high levels of unemployment are making it essential to find new means of~~, is primarily contingent on people being in employment, and therefore calls for new ways and means to be found so as to be able to continue to fund~~ing~~ welfare systems in Europe;

Amendment 71 #

Draft opinion
Paragraph 6

6. Reiterates that the stability of ~~European~~the welfare systems, which are one of the cornerstones of EU cooperation and whose budgets differ greatly from one Member State to another, is contingent on people being in employment, and that high levels of unemployment are making the very high levels of unemployment in the Member States of southern Europe, such as Greece, Portugal, Italy and Spain, are a reflection of the social inequalit ies~~sential to find new means of funding welfare~~ that exist within the Union;

Amendment 72 #

Draft opinion
Paragraph 6

6. Reiterates that the stability of European welfare systems, which are one of the cornerstones of EU cooperation and whose budgets differ greatly from one Member State to another, is contingent on people being in employment, and that high levels of unemployment are making it essential to find new means of funding welfare; condemns the transforming of health as an inherent right for all people, to a market based commodity that is subject to cost and profiteering which creates a social divide by promoting differential treatment based on a patient's ability to pay;

Amendment 73 #

Draft opinion
Paragraph 7

~~7. Reiterates that part of the reason why businesses are becoming less competitive and why welfare spending is so high is that EU rules – including rules on drug pricing – are too burdensome.~~deleted

Amendment 74 #

Draft opinion
Paragraph 7

Amendment 75 #

Draft opinion
Paragraph 7

Amendment 76 #

Draft opinion
Paragraph 7

Amendment 77 #

Draft opinion
Paragraph 7

Amendment 78 #

Draft opinion
Paragraph 7

Amendment 79 #

Draft opinion
Paragraph 7

Amendment 8 #

Draft opinion
Recital B

~~B. whereas people living with disabilities are the most vulnerable and need medicines the most;~~deleted

Amendment 80 #

Csaba SÓGOR

Draft opinion
Paragraph 7

7. ~~Reiterates that part of the reason why businesses are becoming less competitive and why welfare spending is so high is that EU rules – including rules on drug pricing – are too burdensome~~Stresses the need for EU medicine market regulation to ensure a high degree of consumer safety and health protection, to ensure intellectual property rights and, at the same time a healthy competition through the use of generic medicines.

Amendment 81 #

Laura AGEA, Tiziana BEGHIN, Daniela AIUTO, Piernicola PEDICINI

Draft opinion
Paragraph 7

7. Reiterates that part of the reason why businesses are becoming less competitive and why welfare spending is so high is that EU rules – including rules on drug pricing – are too burdensome, in addition to which, austerity and economic adjustment policies are causing increased unemployment and resulting in welfare cuts.

Amendment 82 #

Draft opinion
Paragraph 7

7. Reiterates that part of the reason why businesses are becoming less competitive and why welfare spending is so high is that EU rules – including rules on drug pricing – are too burdensome.; points out that price of most medicines is out of proportion to the cost of manufacturing them; emphasises, in that connection, that firms' competitive position should have no bearing on the final price of medicines;

Amendment 83 #

Laura AGEA, Tiziana BEGHIN, Daniela AIUTO, Piernicola PEDICINI

Draft opinion
Paragraph 7 a (new)

7a. Points out that it is the pharmaceutical industry which is pressing for the enforcement of the rules on patents and thus preventing the use of generic drugs, which are cheaper and could thus be made more widely available; calls for information and awareness-raising campaigns to encourage the use of generic drugs;

Amendment 84 #

Draft opinion
Paragraph 7 a (new)

7a. Calls on the Commission to find solutions to bring unprofitable but medically necessary drugs in to production;

Amendment 85 #

Draft opinion
Paragraph 7 b (new)

7b. Calls on the Commission to increase research for neglected diseases;

Amendment 9 #

Draft opinion
Recital B

B. whereas people living with B. disabilities, as well as those with long term illnesses that are not life threatening but do hamper and hinder quality of life and make everyday living more difficult than for a person in full health, are the most vulnerable and need medicines the most;

source: 587.640

2016/09/09 DEVE 84 amendments...

Amendment 1 #

Draft opinion
Paragraph 1

1. Recalls thate 2030 Agenda for Sustainable Development Goal 3, with nine quantitative and four qualitative targets, clearly states that by 2030 everyone should have access to good mental and physical health throughout their lives; underlines that, each year, 100 million people fall into poverty because of health costs, adopted by the United Nations on 25 September 2015, and Sustainable Development Goal (SDG) No 3 thereof, to ‘Ensure healthy lives and promote well-being for all at all ages’, under which tar~~e disproportionate to their incom~~get 3b is to ‘provide access to affordable essential medicines, and vaccines’; emphasises that, according to the WHO, over one third of the world’s population, with over 50 % in Africa, does not have access to medicines;

Amendment 10 #

Draft opinion
Paragraph 1 a (new)

1a. Points out that development aid, including for access to medicines, should always entail helping the recipients to help themselves, and that people in developing countries must have the prospect of being able to lead decent lives in the place they come from; points out that the problems in such countries will not be solved by people emigrating to Europe because they do not have adequate access to medicines; calls, therefore, for priority to be given to measures that private companies in the countries concerned can support through investment and in terms of organisation; consequently calls for support to be given, in the context of promoting access to medicines, to projects that the recipient countries or companies based there will be able to carry on independently, without foreign aid, after the project support period ends;

Amendment 11 #

Beatriz BECERRA BASTERRECHEA, Charles GOERENS

Draft opinion
Paragraph 1 a (new)

1a. Stresses that some of the barriers to accessing medicines in developing countries include lack of infrastructure, poor quality pharmaceuticals (which are harmful and foster drug resistance), resource constraints, weak pharmaceutical policies, poorly managed supply chains, lack of trained healthcare workers, pricing and limited access to social protection schemes; underlines therefore that the issue of access to medicines in the developing world has to be seen in a broader context and urges the EU to step up efforts to improve countries capacities and help them design working health systems, that aim at improving access to services, particularly for the vulnerable communities;

Amendment 12 #

Draft opinion
Paragraph 1 a (new)

1a. Notes that Article 25 of the UDHR recognises the right of every person to a 'standard of living adequate for the health and well-being of himself and of his family', and that the World Health Organisation (WHO) constitution states that the enjoyment of the highest attainable standard of health is one of the fundamental rights of every human being without distinction of race, religion, political belief, economic or social condition;

Amendment 13 #

Draft opinion
Paragraph 1 a (new)

1a. Recalls that is the fundamental right of each individual to enjoy the best possible state of health;

Amendment 14 #

Draft opinion
Paragraph 1 a (new)

1a. Recalls that a high level of human health protection shall be ensured in the definition and implementation of all Union policies and activities, as stated by Article 168 of the TFEU;

Amendment 15 #

Louis MICHEL

Draft opinion
Paragraph 1 a (new)

1a. Highlights the need to combat counterfeit and low-quality medicines, which are found particularly in developing countries; stresses that such medicines represent a crime against human safety; stresses the direct connection between counterfeiting and organised crime facilitating money laundering and the financing of dangerous networks; calls on pharmaceutical groups to participate in discussing these problems;

Amendment 16 #

Doru-Claudian FRUNZULICĂ, Norbert NEUSER, Linda McAVAN

Draft opinion
Paragraph 1 a (new)

1a. Recalls that the aim should be reaching people who need health care, when and where they need it while acknowledging that availability of medicines, as well as all the elements of health care systems, are subject to conflicts and emergencies, in which case emergency response systems are deemed necessary to effectively prevent and/or respond to a possible outbreak;

Amendment 17 #

Draft opinion
Paragraph 1 a (new)

1a. Stresses the importance of developing a comprehensive access to medicines policy that ensures that all EU policies (global public health, development, research and trade) are consistent with, and beneficial for, access to affordable medicines for citizens in the EU and low-and middle-income countries alike;

Amendment 18 #

Draft opinion
Paragraph 1 a (new)

1a. Considers that when improving the access to medicines in ACP countries, Union assistance should respect the Declaration of the 21st session of the ACP Parliamentary Assembly (A (2010) 21584 of 20 October 2010);

Amendment 19 #

Draft opinion
Paragraph 1 b (new)

1b. Stresses that building strong surveillance and delivery systems at all levels, from community to district, provincial and national levels supported by high quality laboratory services and strong logistical systems could make access to medicines more feasible; while the transfer of health-related technologies (through licence agreements, provision of information, know-how and performance skills, to technical materials and equipment) to developing countries can enable recipient countries to produce the product locally and may result in increased access to the product and improved health;

Amendment 2 #

Draft opinion
Paragraph 1

1. Recalls that the highest attainable standard of health is a fundamental right of every human being; Recalls that Sustainable Development Goal 3, with nine quantitative and four qualitative targets, clearly states that by 2030 everyone should have access to good mental and physical health throughout their lives; underlines that, each year, 100 million people fall into poverty because of health costs which are disproportionate to their incomes, and that, according to the WHO, over one third of the world’s population, with over 50 % in Africa, does not have access to medicines;

Amendment 20 #

Beatriz BECERRA BASTERRECHEA, Charles GOERENS, Paavo VÄYRYNEN

Draft opinion
Paragraph 1 b (new)

1b. Recalls that SDG target 3.b demands all countries to support the research and development of vaccines and medicines for the communicable and non- communicable diseases that primarily affect developing countries and to provide access to affordable essential medicines and vaccines; calls on EU institutions and Members states to give high priority to these issues;

Amendment 21 #

Draft opinion
Paragraph 1 b (new)

1b. Is of the view that the accomplishment of effective medicine provision in developing countries is still an unresolved challenge; considers that lifesaving medicines aren't just another consumer good, and thus, should not be regulated as such;

Amendment 22 #

Louis MICHEL

Draft opinion
Paragraph 1 b (new)

1b. Highlights the fact that investment in health is a major driver of economic development and a key factor in social cohesion;

Amendment 23 #

Beatriz BECERRA BASTERRECHEA, Charles GOERENS, Paavo VÄYRYNEN

Draft opinion
Paragraph 1 c (new)

1c. Observes that the EU’s current biomedical R&D system based on IP monopolies has proved a failure to deliver accessibility for life saving medicines in the developing world, and that the EU has not received sufficient return on its public investment in biomedical R&D with regards to the property on the outcome of research;

Amendment 24 #

Beatriz BECERRA BASTERRECHEA, Charles GOERENS, Paavo VÄYRYNEN

Draft opinion
Paragraph 1 d (new)

1d. Calls to restructure our biomedical R&D system in order for it to be capable of developing efficient access to medicines policies, within the framework of the EU's development policy, capable of effectively delivering lifesaving drugs to millions in the developing world which are currently excluded from access;

Amendment 25 #

Beatriz BECERRA BASTERRECHEA, Charles GOERENS, Paavo VÄYRYNEN

Draft opinion
Paragraph 1 e (new)

1e. Reminds that the Least Developed Countries are the most affected by poverty-related diseases, especially HIV/AIDS, malaria, tuberculosis, diseases of the reproductive organs and infectious and skin diseases;

Amendment 26 #

Beatriz BECERRA BASTERRECHEA, Charles GOERENS, Paavo VÄYRYNEN

Draft opinion
Paragraph 1 f (new)

1f. Considers that the lack of access to health is the result of both a problem of access to care (owing to a shortage of facilities and health workers but also to the lack of public healthcare systems) and access to treatment;

Amendment 27 #

Doru-Claudian FRUNZULICĂ, Norbert NEUSER, Linda McAVAN

Draft opinion
Paragraph 2

Amendment 28 #

Draft opinion
Paragraph 2

Amendment 29 #

Doru-Claudian FRUNZULICĂ, Norbert NEUSER, Linda McAVAN

Draft opinion
Paragraph 2

2. Urges not to use free trade agreements with low- and middle-income countries (LMICs) to introduce TRIPS- plus intellectual property (IP) rules that extend monopoly protection, and not to introduce new IP enforcement rules or investment protection to the detriment of access to medicinesDraws attention to the Declaration on the TRIPS Agreement and Public Health, adopted on 14 November 2001, which states that the TRIPS Agreement should be implemented and interpreted in a way that is good for public health – encouraging both access to existing medicines and the development of new ones; welcomes in this regard the decision by the World Trade Organisation’s TRIPS Council to extend until January 2033 the derogations for Least Developed Countries (LDCs);

Amendment 3 #

Draft opinion
Paragraph 1

1. Recalls that Sustainable Development Goal 3, with nine quantitative and four qualitative targets, clearly states that by 2030 everyone should have access to good mental and physical health throughout their lives, which cannot be achieved without efficient and effective investment in new improved prevention, treatment and diagnostic tools; underlines that, each year, 100 million people fall into poverty because of health costs which are disproportionate to their incomes, and that, according to the WHO, over one third of the world’s population, with over 50 % in Africa, does not have access to medicines;

Amendment 30 #

Draft opinion
Paragraph 2

2. Urges not to use free trade agreements with low- and middle-income countries (LMICs) to introduce TRIPS- plus intellectual property (IP) rules that extend monopoly protection, and not to introduce new IP enforcement rules or investment protection to the detriment of access to medicinesAcknowledges that intellectual property plays an important role in the development of new medicines and represents therefore a tool to improve availability of medicines; takes the view that the international intellectual property system must reflect in a balanced way the concerns of the least developed countries (LDC) regarding access to medicines; notes the decision of 6 November 2015 of the WTO TRIPS Council to extend drug patent exemption for LDCs until January 2033;

Amendment 31 #

Draft opinion
Paragraph 2

2. Urges not to use free trade agreements with low- and middle-income countries (LMICs) to introduce TRIPS- plus intellectual property (IP) rules that extend monopoly protection and limit people's rights to health, and not to introduce new IP enforcement rules or investment protection to the detriment of access to medicines; calls, in this regard, on the Commission to safeguard the right of countries to regulate and preserve policy space in order to guarantee universal access to medicines; urges the Commission to ensure that trade agreements and policies do not undermine developing countries' strategic policies to guarantee people's right to health;

Amendment 32 #

Draft opinion
Paragraph 2

2. UEmphasises that the IPR regime for pharmaceutical products shall be consistent with international human rights law and public health requirements; accordingly, urges not to use free trade agreements with low- and middle-income countries (LMICs) to introduce TRIPS- plus intellectual property (IP) rules that extend monopoly protection, and not to introduce new IP enforcement rules or investment protection to the detriment of access to medicines; takes the view that LDCs should not be required to implement TRIPS provisions;

Amendment 33 #

Draft opinion
Paragraph 2

Amendment 34 #

Draft opinion
Paragraph 2

Amendment 35 #

Doru-Claudian FRUNZULICĂ, Norbert NEUSER, Linda McAVAN

Draft opinion
Paragraph 2 a (new)

2a. Calls on the EU to actively promote innovative practices in the pharmaceutical sector that give priority to access-oriented pricing strategies in developing countries, and put a greater focus on neglected and non- communicable diseases;

Amendment 36 #

Draft opinion
Paragraph 2 a (new)

2a. Welcomes the option for voluntary licensing that allows to produce generic drugs with allowance and adapted remuneration of the originator at reduced prices; reminds that in case of national emergency or other circumstances of extreme urgency TRIPS allows compulsory licensing as enables developing countries to produce generics without consent of the originator; stresses that originators usually grant waivers to LDCs and low income countries that exempts them from TRIPS provisions;

Amendment 37 #

Beatriz BECERRA BASTERRECHEA, Charles GOERENS, Paavo VÄYRYNEN

Draft opinion
Paragraph 2 a (new)

2a. Calls on the European Union to support developing countries which use the so-called flexibilities built into the TRIPS Agreement in order to be able to provide essential medicines at affordable prices under their domestic public health programs;

Amendment 38 #

Beatriz BECERRA BASTERRECHEA, Charles GOERENS, Paavo VÄYRYNEN

Draft opinion
Paragraph 2 a (new)

2a. Notes with concern that patents hinder innovation regarding medicines for diseases where there is no profitable market; stresses that medical research should focus on the medical needs of all people, including neglected diseases in developing countries;

Amendment 39 #

Draft opinion
Paragraph 2 b (new)

2b. Calls on the European Commission to include the most neglected diseases among its priorities and to ensure that effective, appropriate, easy-to-use medicines are developed and placed on the market in the developing countries at an affordable price;

Amendment 4 #

Draft opinion
Paragraph 1

1. Recalls that Sustainable Development Goal 3, with nine quantitative and four qualitative targets, clearly states that by 2030 everyone should have access to good mental and physical health throughout their lives; underlines that, each year, 100 million people fall into poverty because of health costs which are disproportionate to their incomes, and that, according to the WHO, over one third of the world’s population, with over 50 % in Africa, does not have access to safe, effective and affordable medicines;

Amendment 40 #

Draft opinion
Paragraph 3

3. ~~Supports competition in generic medicines, which allows broad access to medic~~Recognises the importance of generic and biosimilar medicines, which make for more competition and for savinegs in ~~LMICs; calls, in particular,~~the health sector; calls for the EU to support ~~actively~~not only the governments ~~that use the available legal measures, including TRIPS safeguards and flexibilities,~~of developing countries with a view to protecting and promoteing public health; calls also for the EU to immediately stop targeting countries such as India that have implemented progressive TRIPS-compliant IP policies which promote access to medicines, through its watch-list of ‘priority but also the private sector in its initiatives to promote access to medicines in developing countries’;

Amendment 41 #

Doru-Claudian FRUNZULICĂ, Norbert NEUSER, Linda McAVAN

Draft opinion
Paragraph 3

3. Supports competition in generic medicines, which ~~allows~~can contribute to broader access to medicines in LMICs~~; calls, in particular, for the EU to support actively government~~ and encourages tpha~~t use the available legal measures, including TRIPS safeguards and flexibilities, to protect and promote public health; calls also for the EU~~ rmaceutical companies to factor i~~mmediately stop targeting countries such as India that have implemented progressive TRIPS-compliant IP policies which promote access to medicines, through its watch-list of ‘priority countries’~~n their business models the issue of access to medicines in the developing world;

Amendment 42 #

Draft opinion
Paragraph 3

3. Supports competition in generic medicines within the negotiated rules, which allows broad access to medicines in LMICs; calls, in particular, for the EU to support actively governments that use the available legal measures, including TRIPS safeguards and flexibilities, to protect and promote public health; calls also for the EU to immediately stop targeting countries such as India that have implemented progressive TRIPS-compliant IP policies which promote access to medicines, through its watch-list of ‘priority countries’ in case of emergency;

Amendment 43 #

Draft opinion
Paragraph 3

3. Supports competition in generic medicines, which allows broad access to medicines in LMICs; calls, in particular, for the EU to support actively governments that use the available legal measures, including TRIPS safeguards and flexibilities, to protect and promote public health; calls also for the EU to ~~immediately stop targeting countries such a~~soften its approach towards India that have implemented progressive TRIPS- compliant IP policies which promote access to medicines, through its watch-list of ‘'priority countries’';

Amendment 44 #

Ivan JAKOVČIĆ

Draft opinion
Paragraph 3

3. Supports competition in generic medicines, which allows b~~road~~etter access to medicines in LMICs; calls, in particular, for the EU and the Member States to support actively governments that use the available legal measures, including TRIPS safeguards and flexibilities, to protect and promote public health; calls also for the EU to immediately stop targeting countries such as India that have implemented progressive TRIPS- compliant IP policies which promote access to medicines, through its watch-list of ‘priority countries’;

Amendment 45 #

Draft opinion
Paragraph 3

3. Supports competition in generic medicines, which allows broad access to medicines in LMICs; calls, in particular, for the EU to support actively governments that use the available legal measures, including TRIPS safeguards and flexibilities (such as compulsory licencing provisions and parallel imports), to protect and promote public health; calls also for the EU to immediately stop targeting countries such as India that have implemented progressive TRIPS- compliant IP policies which promote access to medicines, through its watch-list of ‘'priority countries’';

Amendment 46 #

Draft opinion
Paragraph 3

3. Supports competition in generic medicines, which allows broad access to medicines in LMICs; calls, in particular, for the EU to support actively governments that use the available legal measures, including TRIPS safeguards and flexibilities, to protect and promote public health; calls also for the EU to immediately stop targeting countries such as India that have implemented progressive TRIPS- compliant IP policies which promote access to quality controlled medicines, through its watch-list of ‘priority countries’;

Amendment 47 #

Draft opinion
Paragraph 3 a (new)

3a. Recognises the importance of developing generic medicines for developing countries while at the same time supporting investment for research and development of new drugs;

Amendment 48 #

Draft opinion
Paragraph 3 b (new)

3b. Believes that achieving access to medicines for all is a shared responsibility between public and private actors; stresses the importance of encouraging multi- stakeholder partnerships and ensuring the full participation of private sector and civil society in the definition of health;

Amendment 49 #

Draft opinion
Paragraph 3 a (new)

3a. Stresses that governments and parliaments of developing countries must retain the right to regulate private investment, including to determine the grounds for granting compulsory licences (as reaffirmed in the 2001 Doha Declaration on TRIPS) and to set conditions on technology transfer that support the country's development; deems essential not to include provisions in investment agreements that allow investor-state-dispute-settlement i.e. with respect to IP or other investment claims based on health products;

Amendment 5 #

Doru-Claudian FRUNZULICĂ, Norbert NEUSER, Linda McAVAN

Draft opinion
Paragraph 1

1. Recalls that Sustainable Development Goal 3, with nine quantitative and four qualitative targets, clearly states that by 2030 everyone should have access to good mental and physical health throughout their lives; underlines that, each year, 100 million people fall into poverty because of health costs which are disproportionate to their incomes, and that, according to the WHO, over one third of the world’s population, with over 50 % in Africa, does not have access to medicines; due to inequalities such as lower education levels, lower incomes and due to limited access to information, limited infrastructure and limited reachability of point of access in rural areas along with lack of diagnosis;

Amendment 50 #

Draft opinion
Paragraph 3 a (new)

3a. Stresses that in LMICs limited accessibility of health medical tools is - next to affordability - also linked to issues such as weak distribution systems and insufficient regulatory capacities, and that for most poverty-related and neglected tropical diseases, acceptable, safe and effective vaccines, drugs and diagnostics are still lacking; calls on the Commission and Member States to step up efforts to address this persisting research gap, and to support LMICs in building respective capacities;

Amendment 51 #

Draft opinion
Paragraph 3 a (new)

3a. Deplores that the current biomedical R&D system has proven, far from presenting incentives for research, to materialise in patent monopolies; compartmentalised and overlapping groups of multiple patents over single goods or technologies (thickets), lack of knowledge transfer and an obscure manipulation of the scientific method, all of which hinders innovation;

Amendment 52 #

Draft opinion
Paragraph 3 b (new)

3b. Recalls that a fair balance must be stroke between innovation and patients' access to affordable medicines; calls on the EU to engage in meaningful technology transfer with LDCs with the aim to reach the SDG 3 objective on health; likewise, calls on the EU to further contribute to the achievement of universal health coverage in developing countries through technical assistance and development aid; more broadly, calls on the EU to encourage policies that "de- link" the financing of R&D from the price of medicines, e.g. through the use of patent pools, open source research, grants, subsidies, etc.;

Amendment 53 #

Draft opinion
Paragraph 4

Amendment 54 #

Doru-Claudian FRUNZULICĂ, Norbert NEUSER, Linda McAVAN

Draft opinion
Paragraph 4

Amendment 55 #

Draft opinion
Paragraph 4

4. Stresses that, without basic transparency of research and development costs to originator companies and information on the actual prices paid for medicines across the EU, ~~any discussion on fair medicine prices remains impossibl~~fair pricing is difficult to determine; recalls the Commission’s commitment to greater transparency of EU positions, specific legal proposals, and negotiating texts in the TTIP negotiations;

Amendment 56 #

Ivan JAKOVČIĆ

Draft opinion
Paragraph 4

4. Stresses that, without information based on transparen~~cy of~~t research and development costs to originator companies and information on the actual prices paid for medicines across the EU, any discussion or conclusions on fair medicine prices remains impossible; recalls the Commission’s commitment to greater transparency of EU positions, specific legal proposals, and negotiating texts in the TTIP negotiations;

Amendment 57 #

Draft opinion
Paragraph 4

4. Stresses that, without transparency of research and development costs to originator companies and information on the actual prices paid for medicines across the EU, any discussion on fair medicine prices remains impossible; recalls the Commission’'s commitment to greater transparency of EU positions, specific legal proposals, and negotiating texts in t~~he TTIP negotiation~~all trade agreements; De-linkage in biomedical R&D shall imply separating research and development costs from the final price of the medicine, thus broadly facilitating access and generic production in the developing world; calls in this regard for enhancing instruments such as price incentives for open source medical research, patent pools, socially responsible licences, imposing strict conditions on the use and exploitation of public research by private corporations to assure a return for public interest, open access to scientific research developed and financed with public funds and transparency on trial results;

Amendment 58 #

Draft opinion
Paragraph 4

4. Stresses that, without transparency of research and development costs to originator companies and information on the actual prices paid for medicines across the EU, any discussion on fair medicine prices remains impossible; stresses equally that the results of clinical trials should be accessible to researchers and the public; recalls the Commission’'s commitment to greater transparency of EU positions, specific legal proposals, and negotiating texts in the TTIP negotiations;

Amendment 59 #

Draft opinion
Paragraph 4

Amendment 6 #

Draft opinion
Paragraph 1

1. Recalls that Sustainable Development Goal 3, with nine quantitative and four qualitative targets, clearly states that by 2030 everyone should have access to good mental and physical health throughout their lives; underlines that, each year, 100 million people fall into poverty because of health costs which are disproportionate to their incomes, and that, according to the WHO, over one third of the world’'s population, with over 50 % in Africa, does not have access to medicines, while an increasing number of sick people in developing countries, especially in Central and South America, are claiming their health rights through the courts;

Amendment 60 #

Draft opinion
Paragraph 4 a (new)

4a. Stresses the need to invest in Research and Development (R&D) with regards to Poverty-related and Neglected Diseases (PRND) in order to achieve affordable, safe and effective medicines and vaccines for all;

Amendment 61 #

Draft opinion
Paragraph 4 a (new)

4a. Deems that TTIP represents a potential threat to developing countries' interest, in a context where TTIP consists of a pioneering effort to strengthen and expand multilateral rules (WTO-Plus) or to generate global standards and norms that will apply to other trade agreements around the world; in particular, notes with concern that TTIP could among others offer new opportunities for the pharmaceutical industry to demand further IP protections and lengthen the period of market exclusivity for its products; emphasises that such move is particularly worrisome for developing countries since it would entail longer monopolies, less generic competition and limits on pricing policies, and therefore damage the public health system of developing countries;

Amendment 62 #

Draft opinion
Paragraph 4 a (new)

4a. Underlines the key role played by public investments in R&D and highlight the importance of implementing measures to ensure a public health return on investments when EU funds are financing medical R&D, including the provision of conditions attached to public R&D funding that ensure biomedical research results in suitable and affordable medicines;

Amendment 63 #

Draft opinion
Paragraph 4 b (new)

4b. Urges towards contributing financially to global initiatives, such as the WHO Global Strategy and Plan of Action on Public Health, Innovation and Intellectual Property that aim at alleviating the access problem through the supply of medicines or capacity building as well as with multi-funder initiatives;

Amendment 64 #

Draft opinion
Paragraph 4 a (new)

4a. Underlines the need for greater transparency and more information on how EU funds are invested in the development of new drugs;

Amendment 65 #

Doru-Claudian FRUNZULICĂ, Norbert NEUSER, Linda McAVAN

Draft opinion
Paragraph 5

5. ~~Urges to take advantage of the ongoing~~Takes notes that the REFIT review process of the EU Tiered Pricing Regulation to repeal it unless it can be amended, in close collaboration with the Commission’s Directorates- General for International Cooperation and Development (DG DEVCO) and for Health and Food Safety (DG SANTÉ), in order to support all measures that countrihas concluded that this legislation still has a role to play in the context of the overall EU strategy to promote an ambitious global health agenda and better access to medicines in poor countries; underlines th~~ave~~ at the~~ir disposal to ensure affordable ac~~ EU Tiered Pricing Regulation remains a valuable instrument to promote lower pricess ~~to medicin~~in developing countries.;

Amendment 66 #

Draft opinion
Paragraph 5

5. Urges to take advantage of the ongoing review process of the EU Tiered Pricing Regulation to repeal it unless it can be amended, in close collaboration with the Commission’s Directorates- General for International Cooperation and Development (DG DEVCO) and for Health and Food Safety (DG SANTÉ), in order to support all measures that countries have at their disposal to ensureopen a broader and transparent discussion on pricing regulation and strategies that improve access to affordable ~~access to~~ medicines.;

Amendment 67 #

Draft opinion
Paragraph 5

5. ~~Urges to take advantage of~~Welcomes the ongoing review process of the EU Tiered Pricing Regulation ~~to repeal it unless it can be amended~~, in close collaboration with the Commission’s Directorates- General for International Cooperation and Development (DG DEVCO) and for Health and Food Safety (DG SANTÉ), in order to ~~support all measures that countries have at their disposal to ensure~~better ensure a worldwide access to affordable ~~access to~~ medicines.;

Amendment 68 #

Draft opinion
Paragraph 5

5. Urges t~~o take~~hat advantage be taken of the ongoing review process of the EU Tiered Pricing Regulation to ~~repeal it unless it~~see if the Regulation can be ~~amend~~revised, in close collaboration with the Commission’s Directorates- General for International Cooperation and Development (DG DEVCO) and for Health and Food Safety (DG SANTÉ), ~~in order~~so as to support all measures that countries have at their disposal to ensure affordable access to medicines.

Amendment 69 #

Draft opinion
Paragraph 5

5. URecalls that tiered pricing doesn't necessarily lead to "affordability". In reverse, experience shows that robust generic competition and technology transfers results in lower prices; urges to take advantage of the ongoing review process of the EU Tiered Pricing Regulation to repeal it unless it can be amended, in close collaboration with the Commission’'s Directorates-General for International Cooperation and Development (DG DEVCO) and for Health and Food Safety (DG SANTÉ), in order to support all measures that countries have at their disposal to ensure affordable access to medicines.;

Amendment 7 #

Draft opinion
Paragraph 1

1. Recalls that Sustainable Development Goal 3, with nine quantitative and four qualitative targets, clearly states that by 2030 everyone should have access to good mental and physical health throughout their lives; underlines that, each year, 100 million people fall into poverty because of health costs which are disproportionate to their incomes, and that, according to the WHO, over one third of the world’s population, with over 50 % in Africa, does not have access to medicines; calls therefore for medicines forthwith to be treated as a public good rather than as commodities;

Amendment 70 #

Draft opinion
Paragraph 5

5. Urges to take advantage of the ongoing review process of the EU Tiered Pricing Regulation to repeal it unless it can be amended, in close collaboration and transparent discussion with the Commission’s Directorates-General for International Cooperation and Development (DG DEVCO) and for Health and Food Safety (DG SANTÉ), in order to support all measures that countries have at their disposal to ensure affordable access to medicines.;

Amendment 71 #

Draft opinion
Paragraph 5

5. Urges to take advantage of the ongoing review process of the EU Tiered Pricing Regulation to repeal it unless it can be amended, in close collaboration with the Commission’s Directorates-General for International Cooperation and Development (DG DEVCO) and for Health and Food Safety (DG SANTÉ), in order to support all measures that countries have at their disposal to ensure affordable access to quality controlled medicines.;

Amendment 72 #

Draft opinion
Paragraph 5 a (new)

5a. Highlights that women and children have less access to medicines in developing countries than adult men due to a lack of availability, accessibility, affordability and acceptability in terms of discrimination based on cultural, religious or social factors, and poor quality of health facilities;

Amendment 73 #

Draft opinion
Paragraph 5 a (new)

5a. The Union, through its assistance, shall ensure that woman's dignity and maternal health is not jeopardized by interventions that compromise prenatal and/or postnatal care;

Amendment 74 #

Draft opinion
Paragraph 5 b (new)

5b. Warms that the global incidence of dengue fever has grown dramatically in recent decades, particularly in tropical and sub-tropical developing countries, and that the lack of proper medication to reduce the symptoms of dengue fever will worsen the situation as early detection and access to proper medical care reduces fatality rates below 1%;

Amendment 75 #

Draft opinion
Paragraph 5 c (new)

5c. Urges the need for an international rapid emergency unit, coordinated between public and private sector, to immediately provide proper medicines for patients in the developing world who are suffering from a viral or bacterial outbreak;

Amendment 76 #

Draft opinion
Paragraph 5 a (new)

5a. Urges the EU to step up its support to the global programs promoting access to medicines in developing countries, whether through the World Health Organization or public-private partnerships such as the Global Fund to fight AIDS, Tuberculosis and Malaria or the Gavi Alliance, which have been instrumental in advancing health goals and greatly improved access to medicines; welcomes, from this perspective, the recently approved increase of the EU contribution to the Global Fund;

Amendment 77 #

Draft opinion
Paragraph 5 a (new)

5a. Considering that tuberculosis has become the world's leading infectious killer and that the most dangerous form of the disease is the multi-drug resistant one, underlines the importance of tackling the emerging antimicrobial resistance crisis, including funding research and development for new tools for vaccines, diagnostics and treatment for tuberculosis, while ensuring sustainable and affordable access for those new tools to make sure no one is left behind;

Amendment 78 #

Charles GOERENS

Draft opinion
Paragraph 5 a (new)

5a. Points out that the European Parliament recognises the universal right to health care, and emphasises that the EU and its Member States have a responsibility to address the needs of patients suffering from rare diseases or living in areas where poverty makes access to medicines very difficult; invites Parliament’s Committee on the Environment, Public Health and Food Safety and its Committee on Development to draw up a report on these problems.

Amendment 79 #

Draft opinion
Paragraph 5 a (new)

5a. Calls on the Commission to implement the principle of delinkage in its research funding whereby the costs of research and development (R&D) is separated from the end price of the product, and implementing the guiding R&D principles adopted by all Member States at the WHO namely that R&D should be needs-driven and ensure affordability, effectiveness, efficiency and equity;

Amendment 8 #

Draft opinion
Paragraph 1 a (new)

1a. Recognises that developing medicines and medical research is a multibillion business which indicates the complexity of providing easy access to medicines for developing countries which requires the need for proper national and international legislation to remove the obstacles for developing countries to have access to medicine;

Amendment 80 #

Draft opinion
Paragraph 5 a (new)

5a. Points out that all those involved in EU efforts to improve access to medicines must respect the social, cultural, political and religious characteristics of the target populations; notes that, to make a success of cooperation for development, it is important that the culture and the social and religious characteristics of developing countries are fully respected.

Amendment 81 #

Draft opinion
Paragraph 5 a (new)

5a. Urges the Commission, as a member of boards of global health organisations that address access to medicines and vaccines, such as WHO, The Global Fund, UNFPA, to actively support their initiatives and to aid in promoting and driving the policy agendas towards that direction;

Amendment 82 #

Draft opinion
Paragraph 5 b (new)

5b. The EU reaffirms the importance of co-financing the access to medicines as facilitating principle that motivates grant beneficiaries to higher accountability and contribution to development effectiveness and improves cooperation of all stakeholders recommended by the Istanbul principles. In this respect, the financial contribution in operating grants from the EU budget to one beneficiary in one calendar year should not exceed 50% of the overall annual budget of that beneficiary. (Istanbul Principles, as agreed at the Open Forum's Global Assembly in Istanbul, September 28 -30, 2010);

Amendment 83 #

Draft opinion
Paragraph 5 b (new)

5b. Highlights the critical need to develop local capacities in terms of pharmaceutical research and medicines production in developing countries; calls for support to innovative ways to address this issue, such as the development of product development partnerships and open centres of research and production in the developing world;

Amendment 84 #

Draft opinion
Paragraph 5 c (new)

5c. In respect to the legally binding international human rights instruments, the EU acquis communautaire and the Union policy competencies in this matter, no reference related to the access to medicines should be interpreted as providing legal basis to fund abortion directly or indirectly. In implementing the specific Cairo International Conference on Population and Development (ICPD) prohibition on coercion or compulsion in sexual and reproductive health matters (A/CONF.171/13, Report of the ICPD, 18 Oct 1994, § 7.24), Union assistance seeking to improve the access to medicines should not be provided to any authority, organisation or programme which promotes, supports or participates in the management of any action which involves such human rights abuses as coercive abortion, forced sterilisation of women and men, determining foetal sex resulting in pre natal sex selection or infanticide, especially where such actions apply their priorities though psychological, social, economic or legal pressure;

Amendment 9 #

Draft opinion
Paragraph 1 a (new)

1a. Notes with concern that according to the WHO, most low- and middle- income countries lack a robust institutional framework to mitigate high prices of patented pharmaceutical products; stresses that human right to health, which includes access to medicine and health technologies, supersedes IPRs; recalls that in line with SDG 3, governments have a duty to develop universal health coverage and to ensure that all people have equitable and affordable access to medicine and health technologies; in particular, deems that all governments have a duty to: i) invest public resources in basic science and in medical R&D; ii) develop norms and systems that prioritize R&D towards patient-driven health needs; iii) promote transparency and coordination of efforts in R&D; iv) ensure affordability and access to medicines; v) and create the necessary legal instruments to monitor and hold accountable pharmaceutical companies in relation to their human rights responsibilities and access to medicines;

source: 589.201

2016/10/04 JURI 93 amendments...

Amendment 1 #

Draft opinion
Recital A

A. whereas protection of health is a fundamental right recognised in Article 35 of the Charter of Fundamental Rights of the European Union and Article 168 of the Treaty on the Functioning of the European Union, and enshrined in the European Convention on Human Rights;

Amendment 10 #

Draft opinion
Recital B

B. whereas EUmany of the EU Member States' public budgets, including those covering health expenditure, are under significant constraints; whereas Member States have exclusive competence to fix the prices of medicinal products;

Amendment 11 #

Draft opinion
Recital B

B. whereas EU public budgets, including those covering health expenditure at national EU Member State level, are under significant constraints;

Amendment 12 #

Draft opinion
Recital B

B. whereas EUthe public budgets of EU Member States such as Greece, including those covering health expenditure, are under significant constraints;

Amendment 13 #

Draft opinion
Recital B

B. whereas EUMember States’ public budgets, including those covering health expenditure, are under significant constraints;

Amendment 14 #

Draft opinion
Recital C

C. whereas the WTO Doha Declaration on the TRIPS Agreement and Public Health acknowledges the role of intellectual property protection in the development of new medicines, while expressing concerns about its effects on prices, while especially keeping in mind drug development cycles;

Amendment 15 #

Draft opinion
Recital C

C. whereas the WTO Doha Declaration on the TRIPS Agreement and Public Health ~~acknowledg~~underlines the role of intellectual property protection in the development of new medicines~~, while expressing concerns about its effects on prices~~;

Amendment 16 #

Draft opinion
Recital C

C. whereas the WTO Doha Declaration on the TRIPS Agreement and Public Health ~~acknowledges the role of~~recognises that intellectual property protection ins important for the development of new medicines, while ~~expres~~recognising concerns about its effects on prices;

Amendment 17 #

Draft opinion
Recital D

D. whereas competition can lower costs, reduce expenditure on medicines and improve access to affordable medicines, with higher quality standards being observed in the research and development process;

Amendment 18 #

Draft opinion
Recital D

D. whereas competition ~~can lower costs, reduce expenditure on medicines~~is an important factor in the overall balance of the pharmaceutical market and may positively affect and improved access to affordable medicines and foster more research and innovation;

Amendment 19 #

Draft opinion
Recital D

D. whereas competition based on smart protectionism can lower costs, reduce expenditure on medicines and improve access to affordable medicines;

Amendment 2 #

Draft opinion
Recital A

A. whereas protection of health is a fundamental right enshrined in the European Convention on Human Rights; whereas also the promotion of health is referred to in Articles 6 and 168 of the Treaty on the Functioning of the European Union;

Amendment 20 #

Draft opinion
Recital D

D. whereas ~~competi~~the legal protection of inventions c~~an lower costs, reduce expenditure on medicines and~~ontribute to the progress of science and technology and therefore improve access to ~~affordable~~ medicines;

Amendment 21 #

Draft opinion
Recital D

D. whereas eco~~mpetition can lower costs, reduce expenditure on medicines and improve access to affordable medicine~~nomic freedom in the pharmaceuticals sector is undermining the fundamental right to health of all citizens;

Amendment 22 #

Draft opinion
Recital D a (new)

Da. whereas the EU will need to oversee improvements in a range of fields that have an impact on how medicines are produced and distributed;

Amendment 23 #

Draft opinion
Recital D b (new)

Db. whereas special consideration should be awarded to access to medicines for patients, particularly in the less developed Member States;

Amendment 24 #

Draft opinion
Recital D c (new)

Dc. whereas it is important for medicines to be made available in a timely manner with a view to facilitating patients’ access to treatment and increasing the efficiency of national health systems;

Amendment 25 #

Draft opinion
Recital E

E. whereas the rationale ofor patent rights is to make investment in innovation possible and attractive and to ensure that the knowledge contained in patent applications is accessible;

Amendment 26 #

Draft opinion
Recital E a (new)

Ea. whereas there is a need to devise a system of high-quality patents, granted through accessible and efficient procedures, which afford all stakeholders the requisite level of legal certainty;

Amendment 27 #

Draft opinion
Recital E b (new)

Eb. having regard to the strong political commitment of the European Parliament, especially since the beginning of the current parliamentary term, in favour of a more open policy on access to medicines;

Amendment 28 #

Luke Ming FLANAGAN

Draft opinion
Recital E c (new)

Ec. whereas cannabis-based medicines are proven safe and effective in the treatment of many serious illnesses, and are legal in many countries (including within the EU);

Amendment 29 #

Draft opinion
Recital E d (new)

Ed. whereas intellectual property protection is essential in the field of access to medicines and whereas there is a need to identify mechanisms that can help combat the phenomenon of counterfeit medicines;

Amendment 3 #

Draft opinion
Recital A

A. whereas protection of health is a fundamental right of all citizens enshrined in the European Convention on Human Rights;

Amendment 30 #

Draft opinion
Paragraph 1

1. Highlights the fact that the WTO TRIPS Agreement provides flexibilities to patent rights, such as compulsory licensing, which have proved to be a major tool in bringing prices to reasonable levels; hopes that the mechanism for granting and issuing compulsory licences is freed from discretionary judgement and bureaucratic constraints in order to encourage those less developed countries which possess suitable capacities to start production of medicines locally, thereby helping to avoid difficulties in accessing medicines to treat the most vulnerable sectors of the population;

Amendment 31 #

Draft opinion
Paragraph 1

1. ~~Highlights the fact~~Notes that the WTO TRIPS Agreement provides flexibilities to patent rights, such as compulsory licensing, which have ~~proved to be a major tool in bringing prices to reasonable levels~~brought prices down; However, underlines that the exclusivity periods granted through patent law and other mechanisms provide incentives to originator companies to continue innovating;

Amendment 32 #

Draft opinion
Paragraph 1

1. Highlights ~~the fact~~ that the WTO TRIPS Agreement provides flexibilities to patent rights, such as compulsory licensing, which ~~have proved to be a major tool in bringing prices to reasonable level~~can be used as an effective tool in exceptional circumstances established by the law of each WTO member to address public health problems;

Amendment 33 #

Draft opinion
Paragraph 1

1. Highlights the fact that the WTO TRIPS Agreement provides flexibilities to patent rights, such as compulsory licensing, which ~~have proved to be a major tool in bringing prices to reasonable levels~~should be used only in exceptional circumstances , when all other alternatives have been exhausted;

Amendment 34 #

Draft opinion
Paragraph 1

1. ~~Highlights the fact that the WTO TRIPS Agreement provides flexibilities to patent rights, such as compulsory licensing, which have proved to be a major tool in bringing prices to reasonable levels;~~(Does not apply to English version)

Amendment 35 #

Draft opinion
Paragraph 1 a (new)

1a. Stresses the importance of observing the principle of subsidiarity, as each Member State must address any shortcomings on the basis of its own particular requirements;

Amendment 36 #

Draft opinion
Paragraph 1 b (new)

1b. Calls for support for the progress achieved by the pharmaceutical industry, hitherto driven by European SMEs, which have transformed the standard of healthcare in Europe and helped to prolong life expectancy;

Amendment 37 #

Draft opinion
Paragraph 2

~~2. Considers that exclusive protection periods granted to pharmaceuticals through patents or other mechanisms hinder competition, lead to high prices and negatively impact access to needed medicines;~~deleted

Amendment 38 #

Angel DZHAMBAZKI

Draft opinion
Paragraph 2

Amendment 39 #

Draft opinion
Paragraph 2

2. Considers that exclusive protection periods granted to pharmaceuticals through patents or other mechanisms hinder competition, lead to high prices and negatively impact access to needed medicines; observes that the EU´s current biomedical R&D system based on IP monopolies has proved a failure to deliver accessible and affordable lifesaving medicines, and that the EU has not received sufficient return on its public investment in biomedical R&D with regards to the property on the outcome of research;

Amendment 4 #

Draft opinion
Recital A

A. whereas protection of health is a fundamental right ~~enshrin~~guaranteed inby the ~~European Convention on Human Right~~Member States;

Amendment 40 #

Draft opinion
Paragraph 2

2. Considers that exclusive protection periods granted to pharmaceuticals through patents or other mechanisms ~~hinder competition, lead to~~may help sustain research and development departments, but lead to a decrease in competition during those periods, with the higher price~~s and negatively impac~~ for medicines, established on the basis of research costs, potentially having an adverse impact on their purchase by consumers, and even acting to limit access to needed medicines;

Amendment 41 #

Draft opinion
Paragraph 2

2. Considers that exclusive protection periods granted to pharmaceuticals through patents or other mechanisms ~~hinder competition, lead to high prices and negatively impact access to needed medicine~~are an important tool to encourage R&D and provide incentives to innovation; acknowledges, at the same time, the importance of promoting competition and preventing cases of market abuse, as well as the need of ensuring access to needed medicines at affordable prices and guaranteeing the sustainability of national healthcare systems;

Amendment 42 #

Draft opinion
Paragraph 2

2. Considers thatere to be a need to rethink the mechanism for granting exclusive protection periods ~~granted~~ to pharmaceuticals through patents or other mechanisms since these currently hinder competition, lead to high prices and negatively impact access to needed medicines;

Amendment 43 #

Draft opinion
Paragraph 2

2. ~~Consider~~Stresses that exclusive protection periods granted to pharmaceuticals through patents or other mechanisms hinder competition, lead to high prices and negatively impact access to needed medicines;

Amendment 44 #

Draft opinion
Paragraph 2

2. ~~Considers that exclusive protection periods granted to pharmaceuticals through patents or other mechanisms hinder competition, lead to high prices and negatively impact access to needed medicines~~Recognises the key contribution of IP-intensive industries such as the pharmaceutical sector in enhancing the competitiveness of European economy and delivering growth and high-quality jobs in the EU;

Amendment 45 #

Draft opinion
Paragraph 2

Amendment 46 #

Draft opinion
Paragraph 2 a (new)

2a. Reiterates that part of the reason why businesses are becoming less competitive and why welfare spending is so high is that EU rules – including rules on drug pricing – are too burdensome;

Amendment 47 #

Draft opinion
Paragraph 2 b (new)

2b. Considers that for a certain time period exclusive protection periods may be necessary in order to not disrupt the drug trial periods and thereby end the drug development cycle;

Amendment 48 #

Draft opinion
Paragraph 2 c (new)

2c. Notes, that awareness and monitoring is an important aspect of the competent authorities and believes, that improved awareness campaigns are a tool to improve a better understanding of the complex drug development processes for both business and consumers;

Amendment 49 #

Draft opinion
Paragraph 3

Amendment 5 #

Draft opinion
Recital A a (new)

Aa. whereas, in accordance with Article 168 of the Treaty on the Functioning of the European Union concerning the protection of public health, a high level of human health protection should be guaranteed in the definition and implementation of all EU policies and activities; whereas, in this respect, the Union and Member States should foster cooperation with third countries and the competent international organisations in the sphere of public health;

Amendment 50 #

Draft opinion
Paragraph 3

3. Recalls that the Pharmaceutical Sector Inquiry Report adopted by the Commission in 2009 showed that manufacturers of medicines have developed abusive strategies in connection with patent claims in order to hinder market entry of generic medicines, which should be avoided; Asks the Commission to act responsibility and in particular to introduce tougher checks on possible cases of infringements of internal market and competition rules;

Amendment 51 #

Draft opinion
Paragraph 3

3. Recalls that the Pharmaceutical Sector Inquiry Report adopted by the Commission in 2009 showed that manufacturers of medicines have developed abusive strategies in connection with patent claims in order to hinder market entry of generic medicines, which should be avoided, while observing that generic medicines respect the requisite quality standards set to ensure effective treatment;

Amendment 52 #

Draft opinion
Paragraph 3

3. Recalls that the Pharmaceutical Sector Inquiry Report ~~adopt~~led by the Commission in 2009 ~~showed that manufactur~~indicated a numbers of ~~medicines have developed abusive strategies in connection with~~problems in companies' practices that, among other factors such as shortcomings in the regulatory framework, paotent ~~claims in order to hinder~~ially contribute to delays to the market entry of generic medicines~~, which should be avoided~~ and emphasised the importance of stronger competition law enforcement;

Amendment 53 #

Draft opinion
Paragraph 3

Amendment 54 #

Draft opinion
Paragraph 3

3. Recalls that the Pharmaceutical Sector Inquiry Report adopted by the Commission in 2009 showed that some manufacturers of medicines have developed abuggressive strategies in connection with patent claims in order to hinder market entry of generic medicines, which should be avoided;

Amendment 55 #

Angel DZHAMBAZKI

Draft opinion
Paragraph 3

3. Recalls that the Pharmaceutical Sector Inquiry Report adopted by the Commission in 2009 showed that some manufacturers of medicines have developed abusive strategies in connection with patent claims in order to hinder market entry of generic medicines, which should be avoided;

Amendment 56 #

Draft opinion
Paragraph 3

3. Recalls that the Pharmaceutical Sector Inquiry Report adopted by the Commission in 2009 ~~showed that manufacturers of medicin~~identified the numerous regulatory obstacles tha~~ve developed abusive strategies in connection with patent claims in order to hinder market entry of generic medicines, which should be avoided~~t need to be addressed to achieve more efficient innovative and off-patent pharmaceutical markets;

Amendment 57 #

Draft opinion
Paragraph 3 a (new)

3a. Notes that certain markets may benefit from more efficient monitoring and training for competent authorities as well as better inter-governmental cooperation in terms of exchange of best- practises;

Amendment 58 #

Draft opinion
Paragraph 4

4. Calls on the Commission to undertake a critical review of the impact of intellectual-property-related incentives on biomedical innovation, to explore alternatives to monopolies for the financing of medical R&D and to evaluate the functioning of the applicable limitations to patent allocations;deleted

Amendment 59 #

Draft opinion
Paragraph 4

Amendment 6 #

Draft opinion
Recital A b (new)

Ab. whereas, under Article 35 of the Charter of Fundamental Rights of the European Union everyone is guaranteed the right to access1a preventive and curative healthcare and to benefit from medical treatment under the conditions established by national laws and practices; __________________ 1a access must correlate to the patient’s financial means, since otherwise the product may be available on the market, but its price will render it inaccessible.

Amendment 60 #

Draft opinion
Paragraph 4

4. Calls on the Commission to ~~undertake a critical review of~~assess the impact of intellectual-property-related incentives on biomedical innovation, and to explore alternatives ~~to monopolies~~ for the financing of medical R&D ~~and to evaluate the functioning of the applicable limitations to patent allocations~~;

Amendment 61 #

Draft opinion
Paragraph 4

4. Calls on the Commission to undertake a critical review of the impact of intellectual-property-related incentives on biomedical innovation, to explore credible and efficient alternatives to ~~monopolie~~patents for the financing of medical R&D ~~and to evaluate the functioning of the applicable limitations to patent allocations~~;

Amendment 62 #

Draft opinion
Paragraph 4

4. Calls on the Commission to undertake a critical review of the impact of intellectual-property-related incentives on biomedical innovation, to explore alternatives to monopolies for the financing of medical R&D and to ~~evaluate the functioning of the applicable limitations to patent allocations~~assess areas where existing legislation may benefit from a modernisation or streamlining approach;

Amendment 63 #

Pascal DURAND, Enrico GASBARRA

Draft opinion
Paragraph 4

4. Calls on the Commission to undertake a critical review of the impact of intellectual-property-related incentives on biomedical innovation, to explore effective alternatives to ~~monopolie~~patents for the financing of medical R&D and to evaluate the functioning of the applicable limitations to patent ~~allocation~~rights;

Amendment 64 #

Draft opinion
Paragraph 4 a (new)

4a. Calls on the Commission to explore the implementation of delinkage mechanisms, characterized by the uncoupling of R&D costs and the end prices of health products, to finance research and development as mentioned in the report of the United Nations Secretary General's high level Panel on access to medicines - Promoting innovation and access to health technologies; 1a __________________ 1a https://static1.squarespace.com/static/562 094dee4b0d00c1a3ef761/t/57d9c6ebf5e23 1b2f02cd3d4/1473890031320/UNSG+HL P+Report+FINAL+12+Sept+2016.pdf

Amendment 65 #

Draft opinion
Paragraph 4 b (new)

4b. Calls on the Commission to implement a coherent policy at EU level that favours the principle of access to medicines in all the various aspects of EU legislation, starting with international trade and a revision of the laws on patents and infringements of copyright;

Amendment 66 #

Draft opinion
Paragraph 4 c (new)

4c. Calls on the Commission to identify the most effective mechanisms to help combat the phenomenon of counterfeit medicines, in order to ensure intellectual property protection and guarantee a high level of health protection;

Amendment 67 #

Emil RADEV

Draft opinion
Paragraph 4 d (new)

4d. Calls on the European Commission and Member States to strike a balance between stimulating innovation, protecting innovators and ensuring that innovations are of maximum benefit to society;

Amendment 68 #

Angel DZHAMBAZKI

Draft opinion
Paragraph 5

5. Calls on the European Patent Office (EPO) and the Member States to grant patents on health products that strictly fulfil the patentability requirements of novelty, inventive step and industrial applicability as enshrined in the European Patent Convention;deleted

Amendment 69 #

Draft opinion
Paragraph 5

5. Calls on the European Patent Office (EPO) and the Member States to grant patents on health products that strictly fulfil the patentability requirements of novelty, inventive step and industrial applicability ~~as enshrined in the European Patent Convention~~;

Amendment 7 #

Draft opinion
Recital A c (new)

Ac. whereas patients who are EU citizens should have access to innovative medicines that are safe in quality terms and sold on the market at an accessible price;

Amendment 70 #

Draft opinion
Paragraph 5

5. Calls on the European Patent Office (EPO) and the Member States to continue to grant patents on health products that strictly fulfil the patentability requirements of novelty, inventive step and industrial applicability as enshrined in the European Patent Convention;

Amendment 71 #

Draft opinion
Paragraph 5

Amendment 72 #

Draft opinion
Paragraph 5

5. Calls on the European Patent Office (EPO) and the Member States to grant patents only on health products that strictly fulfil the patentability requirements of novelty, inventive step and industrial applicability as enshrined in the European Patent Convention;

Amendment 73 #

Draft opinion
Paragraph 5

5. ~~Calls on~~Notes that the European Patent Office (EPO) and the Member States to grant patents on health products that strictly fulfil the patentability requirements of novelty, inventive step and industrial applicability as enshrined in the European Patent Convention;

Amendment 74 #

Draft opinion
Paragraph 6

~~6. Calls on the Commission to encourage Member States to fully implement existing patent limitations and flexibilities when confronted with excessive pricing or abuse of monopoly rights;~~deleted

Amendment 75 #

Draft opinion
Paragraph 6

6. Calls on the Commission to encourage Member States to fully implement existing patent limitations and flexibilities when confronted with excessive pricing or abuse of monopoly rights; underlines the key role played by public investments in R&D and highlight the importance of implementing measures to ensure a public health return on investments when EU funds are financing medical R&D, including the provision of conditions attached to public R&D funding that ensure biomedical research results in suitable and affordable medicine;

Amendment 76 #

Draft opinion
Paragraph 6

6. Calls on the Commission to encourage Member States to fully implement existing patent limitations and flexibilities when confronted with excessive pricing or abuse of monopoly rights; calls in this respect on the Commission to undertake to carry out an analysis of the patent system for medicinal products within the internal market, in particular to check whether patents for drugs facilitate the movement of products in fragile, non-competitive sectors, such as the treatment of rare diseases;

Amendment 77 #

Draft opinion
Paragraph 6

6. Calls on the Commission to encourage Member States to fully implement existing patent limitations and flexibilities ~~when confronted with excessive pricing or abuse of monopoly right~~in duly justified cases, such as cases of national emergencies, other circumstances of extreme urgency or anti- competitive practices;

Amendment 78 #

Emil RADEV

Draft opinion
Paragraph 6

Amendment 79 #

Draft opinion
Paragraph 6

6. Calls on the ~~Commission to encourage Member States to fully implement existing patent limit~~Member States to fully cooperate and exchange informations and ~~flexibilities when confronted with excessive pricing or abuse of monopoly righ~~expertise among each other in order to prevent excessive pricing of medicines and to ensure market access of generic products;

Amendment 8 #

Draft opinion
Recital A d (new)

Ad. whereas there is a need for voluntary cooperation between Member States with a view to increasing the financial accessibility of medicinal products and ensuring EU citizens have suitable access to them;

Amendment 80 #

Draft opinion
Paragraph 7

Amendment 81 #

Draft opinion
Paragraph 7

7. Calls on the Commission to establish full transparency on the results of publicly financed R&D so that patenting and licensing conditions guarantee a public health return on public investments and reflect the structure of R&D funding; Calls on the Commission to introduce best practices so as to encourage a positive conditionality with the aim of promoting forms of sharing and a greater circulation of patents.

Amendment 82 #

Draft opinion
Paragraph 7

7. Calls on the Commission and the Member States to establish full transparency on the results of publicly financed R&D so that patenting and licensing conditions guarantee a public health return on public investments and reflect the structure of R&D funding.

Amendment 83 #

Draft opinion
Paragraph 7

7. Calls on the Commission to establish full transparency and public disclosure on the results of publicly financed R&D so that patenting and licensing conditions guarantee a public health return on public investments and reflect the structure of R&D funding.

Amendment 84 #

Draft opinion
Paragraph 7

7. Calls on the Commission to establish full transparency on the results of publicly financed R&D so that patenting and licensing conditions guarantee a public health return on public investments and reflect the structure of R&D fundingudy the different factors which cause excessive prices, such as national regulatory and economic approaches, and to assess how those issues could be tackled at European level.

Amendment 85 #

Draft opinion
Paragraph 7 a (new)

7a. Stress the importance of developing a comprehensive access to medicines policy that ensures that all EU policies (global public health, development, research and trade) are consistent with, and beneficial for, access to affordable medicines for citizens in the EU and low-and middle-income countries alike, calls on the Commission to further explore the numerous tools providing new incentives for health technology innovation, such as mechanisms delinking the costs of research and development from the end product, as outlined by the World Health Organisation Global Strategy Plan of action (2008) and in the recent United Nations Secretary General's high level Panel on access to medicines - Promoting innovation and access to health technologies

Amendment 86 #

Luke Ming FLANAGAN

Draft opinion
Paragraph 7 b (new)

7b. Calls on the Commission to establish a comprehensive transnational patent drugs price comparison website, so that citizens in individual Member States can see at a glance how and where they are being overcharged for their prescriptions, and to expose all instances of overcharging.

Amendment 87 #

Draft opinion
Paragraph 7 c (new)

7c. The following are prerequisites when it comes to establishing instruments that can lead to transparent assessment of the level of access to medicines: (a) analysis of the relationship between the benefits deriving from the original medicinal products with an impact on European health systems, with reference to the distribution point, and the price, which must be applied on the basis of the research and innovation costs; (b) analysis of whether patients’ access to generic medicines really is of a significantly higher level than for the original products, with a view to ensuring health protection and enhancing consumers’ quality of life; (c) analysis of the risk-benefit ratio for access to generic medicines; (d) assessment of the information communicated both to consumers and to healthcare professionals, and of the provisions attached to the generic medicines process versus that for original products.

Amendment 88 #

Draft opinion
Paragraph 7 d (new)

7d. Calls again on the Commission to give political impetus to the proposal to amend Directive 89/105 in order to obtain more transparent and thus more reasonable prices; asks the Commission to step up efforts, as provided by the law in force, to ensure public access to appropriate information on the safety and effectiveness of medicines;

Amendment 89 #

Draft opinion
Paragraph 7 e (new)

7e. Calls on the Commission to request the Member States to define public policies and produce statistical evidence on the number of chronically ill persons, broken down by illness, and the forecast for the coming 5 to 10 years;

Amendment 9 #

Draft opinion
Recital B

B. whereas ~~EU public budgets, including those covering health expenditure, are under significant constraints~~, also as a result of the economic crisis and austerity policies, European public budgets, in particular for the sectors covering health expenditure, are under significant pressure because of sovereign debts and the requirements to contain spending;

Amendment 90 #

Emil RADEV

Draft opinion
Paragraph 7 f (new)

7f. Stresses the need to establish robust health systems, based on new pricing models.

Amendment 91 #

Draft opinion
Paragraph 7 g (new)

7g. Calls on the Commission to launch discussions on devising a procedure for establishing (on the basis of age, type of chronic illness, income, etc.) the socially-disadvantaged categories to which innovative medicines could be made available, on an exceptional basis, before the patent expires;

Amendment 92 #

Draft opinion
Paragraph 7 h (new)

7h. Asks the Commission to pay particular attention to 'evergreening', i.e. the practice whereby slight modifications of existing products are patented as new inventions in order to perpetuate the patent and the privileges arising therefrom;

Amendment 93 #

Draft opinion
Paragraph 7 i (new)

7i. Calls on the Commission to introduce transparent mechanisms for correctly setting the price of medicines available on the market.

source: 592.063

2016/10/21 ENVI 599 amendments...

Amendment 1 #

Motion for a resolution
Citation 1 a (new)

- having regard to Article 168 of the Treaty on the Functioning of the European Union, a high level of human health protection should be ensured in the definition and implementation of all Union policies and activities,

Amendment 10 #

Motion for a resolution
Citation 3 b (new)

- having regard the Council Conclusions of 1 December 2014 on Innovation for the benefit of patients

Amendment 100 #

Motion for a resolution
Recital E a (new)

Ea. whereas only around 3% of health budgets goes towards measures to prevent and promote public health;

Amendment 101 #

Motion for a resolution
Recital E b (new)

Eb. whereas the private sector currently holds a monopoly on the production facilities and whereas the EU has to face a widely recognised market failure leading to a lack of private investment in R&D in combating non- competitive segments for which the market does not provide sufficient financial return, such as antimicrobial resistance, rare diseases or poverty-related diseases;

Amendment 102 #

Motion for a resolution
Recital E c (new)

Ec. whereas the number of new medicines put on the market has continuously been decreasing in last years and whereas among the new medicines, only 1% were seen as innovative or a real therapeutic advance by Prescrire, an independent critical drug information journal in France;

Amendment 103 #

Motion for a resolution
Recital E d (new)

Ed. whereas the sector inquiry led by the Commission has shown that from 2000 – 2007 originator companies spent on average 17% of their turnover from prescription medicines on R&D worldwide (approximately 1.5% of turnover was spent on basic research to identify potential new medicines and 15.5% of turnover was spent on developing the identified potential medicines through trials into products sufficiently safe and efficacious to be marketed), while expenditure on marketing and promotional activities accounted for 23% of their turnover during the period;

Amendment 104 #

Motion for a resolution
Recital E e (new)

Ee. whereas on 31st August 2016, on the basis of urgent public interest, the German Federal Patent Court issued a compulsory licence for an HIV drug as requested by the company Merck, after the patent holding company Shionogi had rejected Merck's offer for a voluntary worldwide license on the patent; whereas the NGO Médecins du Monde successfully filed a patent opposition to sofosbuvir, the active substance of a new drug against Hepatitis C owned by the company Gilead that was added to the WHO list of essential medicines in 2014, the EPO deciding on 5th October 2016 that Gilead's patent extended beyond the content of the patent application as filed;

Amendment 105 #

Motion for a resolution
Recital C

F. whereas the Commission has ~~had to~~ introduced incentives to promote research in areas such as rare diseases~~, and whereas 25 000 people die each year in the EU owing to lack of access to adequate antimicrobial drugs~~;

Amendment 106 #

Motion for a resolution
Recital F

F. whereas the Commission has had to introduce incentives to promote research in areas such as rare diseases~~, and wher~~; whereas it is estimated that every year in the EU at least 25 000 people die ~~each year in the EU owing to lack of access to adequate antimicrobial drug~~of infections caused by resistant bacteria while only one novel class of antibiotics has been developed in the past 40 years;

Amendment 107 #

Motion for a resolution
Recital F

F. whereas the Commission has had to introduce incentives to promote research in areas such as rare diseases, and whereas 25 000 people die each year in the EU owing to lack of access to adequate antimicrobial drugs; whereas drug-resistant diseases could cause 10 million deaths per annum worldwide by 2050

Amendment 108 #

José Inácio FARIA, Jasenko SELIMOVIC, Anneli JÄÄTTEENMÄKI, Frédérique RIES, Lieve WIERINCK

Motion for a resolution
Recital F

F. whereas the ~~Commission~~EU legislature has had to introduce incentives to promote research in areas such as rare diseases, and whereas 25 000 people die each year in the EU owing to lack of access to adequate antimicrobial drugs with a cost is 1,5 billion euros year;

Amendment 109 #

Motion for a resolution
Recital F

F. whereas the Commission has had to introduce incentives to promote research in areas such as rare diseases and paediatric illnesses, and whereas 25 000 people die each year in the EU owing to lack of access to adequate antimicrobial drugs;

Amendment 11 #

Motion for a resolution
Citation 4

— having regard to ~~the antitrust procedure, Case AT.39612 – Perindopril (Servier), and to~~ paragraphs 249 and 250 of the judgment of the Court of Justice of 14 February 1978 in Case 27/76 on excessive prices,;

Amendment 110 #

Motion for a resolution
Recital F

F. whereas the Commission has had to introduce incentives to promote research in areas such as rare diseases, and ~~whereas~~deploring the fact that 25 000 people die each year in the EU owing to lack of access to adequate antimicrobial drugs;

Amendment 111 #

Lieve WIERINCK, Gesine MEISSNER, Frédérique RIES, Anneli JÄÄTTEENMÄKI, Marian HARKIN, Jana TOOM, Jasenko SELIMOVIC

Motion for a resolution
Recital F

F. whereas the Commission has had to introduce incentives to promote research in areas such as rare diseases, and whereas 25 000 people die each year in the EU owing to lack of ~~access to~~ adequate antimicrobial drugs;

Amendment 112 #

Karl-Heinz FLORENZ, Peter LIESE, Françoise GROSSETÊTE, Norbert LINS, Andrey KOVATCHEV

Motion for a resolution
Recital F a (new)

F a. whereas there are currently no tools that prevent the public from paying medicines twice, via reimbursement guaranteed by the national public health systems and substantial contributions to financing R&D in the pharmaceutical sector through: - public subsidies to research programmes such as Horizon 2020 and Innovative medicines initiatives (IMI) where attribution of funds is not yet subject to any condition regarding local employment and unpatentability of the results - tax credits

Amendment 113 #

Motion for a resolution
Recital F a (new)

Fa. whereas the gap between the growing resistance to antimicrobial agents and the development of new antimicrobial agents is widening, and whereas 25 000 people die each year in the EU owing to lack of access to adequate antimicrobial agents;

Amendment 114 #

Motion for a resolution
Recital F a (new)

Fa. whereas the regulation on rare diseases has provided an important framework for promoting research on orphan drugs, considerably boosting the treatment of those diseases for which previously no alternative existed;

Amendment 115 #

Elisabetta GARDINI

Motion for a resolution
Recital F a (new)

F a. whereas the Advanced Therapy Medicinal Products (ATMPs) have the potential to reshape the treatment of a wide range of conditions, particularly in disease areas where conventional approaches are inadequate, and whereas only few ATMPs have been authorised so far;

Amendment 116 #

Motion for a resolution
Recital F a (new)

Fa. whereas public investments in Research and Development play a key role in the development of innovative medicines;

Amendment 118 #

Motion for a resolution
Recital G

G. whereas the prices of medicines are usually negotiated by means of bilateral and confidential negotiations between the pharmaceutical industry and Member States and whereas strong asymmetry in negotiation powers is to deplore between globalised multinational pharmaceutical companies and individual Member States that are subject to fiscal and social competition among themselves and with third countries in an attempt to foster attractiveness of their labour market, fight against unemployment and resistance to offshoring blackmailing by the private sector;

Amendment 119 #

Motion for a resolution
Recital G

G. whereas the prices of medicines are ~~usually negotiated by means of bilateral and confidential negotiations between the pharmaceutical industry and Member State~~set in accordance with criteria laid out in national pricing and reimbursement regulations;

Amendment 12 #

Mireille D'ORNANO, Jean-François JALKH, Sylvie GODDYN

Motion for a resolution
Citation 4

— having regard to the antitrust procedure, Case AT.39612 – Perindopril (Servier), and to paragraphs 249 and 250 of the judgment of the Court of Justice of 14 February 1978 in Case 27/76 on excessive prices,deleted

Amendment 120 #

Nikolay BAREKOV

Motion for a resolution
Recital G

G. whereas the prices of medicines are usually negotiated by means of bilateral and confidential negotiations between the pharmaceutical industry and Member States; whereas the pharmaceutical industry is usually better informed about prices of medicines in different Member States than Member States themselves;

Amendment 121 #

Motion for a resolution
Recital G

Amendment 122 #

Lieve WIERINCK, Gesine MEISSNER, Frédérique RIES, Anneli JÄÄTTEENMÄKI, Marian HARKIN, Ulrike MÜLLER, Jasenko SELIMOVIC

Motion for a resolution
Recital G

G. whereas the prices of medicines are usually negotiated by means of bilateral and confidential negotiations between the pharmaceutical industry and Member States, following rules set out in national reimbursement and pricing legislation;

Amendment 123 #

György HÖLVÉNYI, Alojz PETERLE, Miroslav MIKOLÁŠIK

Motion for a resolution
Recital G

G. whereas, due to the current international reference pricing system, the prices of medicines are usually negotiated by means of bilateral and confidential negotiations between the pharmaceutical industry and Member States;

Amendment 124 #

Motion for a resolution
Recital G a (new)

Ga. whereas the EU will need to oversee improvements in a range of fields that have an impact on how medicines are produced and distributed as well as ensuring the right of patients to all relevant information; particularly in the case of public health vaccination programmes;

Amendment 125 #

Mireille D'ORNANO, Jean-François JALKH, Sylvie GODDYN

Motion for a resolution
Recital G a (new)

Ga. whereas the Commission can use the joint procurement agreement on drugs, now signed by 20 Member States, to improve access to innovative medicines in more favourable conditions, and whereas that step will bring down the final cost for patients;

Amendment 126 #

Motion for a resolution
Recital H

~~H. whereas the majority of Member States have their own health care assessment agencies with their own standards;~~deleted

Amendment 127 #

Motion for a resolution
Recital H

H. whereas, in the absence of EU fiscal and social integrated policy, the majority of Member States have their own health care assessment agencies with their own standards;

Amendment 128 #

Motion for a resolution
Recital H

H. whereas the majority of Member States have their own health ~~care~~technology assessment agencies with their own ~~standards~~criteria;

Amendment 129 #

Motion for a resolution
Recital I

I. whereas the entry of generics onto the market is an important mechanism to reduce prices, ~~and whereas there are~~remedy distorted competition, reduce expenditure on medicines and improve universal access to affordable medicines, and whereas the Commission expressed clear concerns about the strategies to delay this entry;

Amendment 13 #

Lieve WIERINCK, Gesine MEISSNER, Frédérique RIES, José Inácio FARIA, Anneli JÄÄTTEENMÄKI, Marian HARKIN, Jana TOOM

Motion for a resolution
Citation 5 a (new)

- having regard to the importance of the recommendations of the report prepared by the High-Level Panel on Access to Health Technologies, convened by the United Nations Secretary-General, published in September 2016

Amendment 130 #

Motion for a resolution
Recital I

I. whereas the entry of generics and biosimilars onto the market is an important mechanism to reduce prices, and ~~whereas there are clear concerns about the strategies to delay this entry~~contributes to ensuring the sustainability of healthcare systems, and whereas market entry of generics and biosimilars should not be delayed;

Amendment 131 #

José Inácio FARIA, Jasenko SELIMOVIC

Motion for a resolution
Recital I

I. whereas the entry of generics and biosimilars onto the market is an important mechanism to increase competition, reduce prices, and whereas there are clear concerns about the strategies to delay this entry;

Amendment 132 #

György HÖLVÉNYI, Alojz PETERLE, Miroslav MIKOLÁŠIK

Motion for a resolution
Recital I

I. whereas the entry of generics and biosimilars onto the market is an important mechanism to reduce prices, and whereas there are clear concerns about the strategies to delay this entry;

Amendment 133 #

Motion for a resolution
Recital I

I. whereas the entry of generics and biosimilars onto the market is an important mechanism to reduce prices, and whereas there are clear concerns about the strategies to delay this entry;

Amendment 134 #

Motion for a resolution
Recital I a (new)

Ia. whereas while the organisation of health systems and of pharmaceutical provision, specifically pricing and reimbursement systems, is a national competence, the EU provides legislation on clinical trials, transparency in pricing, intellectual property, pharmacovigilence, authorisation competences and control of competence, and it is the biggest financial backer of public research;

Amendment 135 #

Nikolay BAREKOV

Motion for a resolution
Recital I a (new)

I a. whereas the provision of therapeutic information is essential for medicinal products with self-medication purposes, and whereas existing EU rules lead to a lack of transparency for non- prescription homeopathic medicines;

Amendment 136 #

Mireille D'ORNANO, Jean-François JALKH, Sylvie GODDYN

Motion for a resolution
Recital I a (new)

Ia. whereas access to affordable and suitable diagnostic tests and vaccines is as critical as access to safe, effective and affordable medicines.

Amendment 137 #

Motion for a resolution
Recital I a (new)

Ia. stresses, however, that the generic medicines market share amounts to 48% for the whole European Union;

Amendment 138 #

Mireille D'ORNANO, Jean-François JALKH, Sylvie GODDYN

Motion for a resolution
Recital I b (new)

Ib. stresses that the generic medicines share should be even higher, but the production of new generic medicines is dependent on the formulation of innovative active ingredients;

Amendment 139 #

Motion for a resolution
Recital J

J. whereas under Article 168 of the Treaty on the Functioning of the European Union (TFEU), Parliament and the Council can, in order to meet common safety concerns, adopt measures setting high standards of quality and safety for medicinal products, and whereas, in accordance with Article 114(3) of the TFEU, legislative proposals in the health sector shall take as a base a high level of protection;

Amendment 14 #

Mireille D'ORNANO, Jean-François JALKH, Sylvie GODDYN

Motion for a resolution
Citation 5 a (new)

- having regard to Decision No 1082/2013/EU of the European Parliament and of the Council of 22 October 2013 on serious cross-border threats to health and repealing Decision No 2119/98/EC,1 a __________________ 1a http://ec.europa.eu/health/preparedness_r esponse/docs/decision_serious_crossborde r_threats_22102013_es.pdf

Amendment 140 #

Motion for a resolution
Recital J

J. whereas under Article 168 of the Treaty on the Functioning of the European Union (TFEU), Parliament and the Council can, in order to meet common safety concerns, adopt measures setting high standards of quality and safety for medicinal products, without forgetting that under the terms of the same article, the Member States’ responsibilities include managing health and medical care services, and allocating resources to those services;

Amendment 141 #

Nikolay BAREKOV

Motion for a resolution
Recital J a (new)

Ja. whereas diseases such as Hepatitis C can be successfully combated with early diagnosis combined with new and old medicines, saving millions of people across the EU; whereas patients with hepatic fibrosis diagnosed at stages F1, F2 and F3 in some Member States face huge problems in getting hold of Sofosbuvir, due to its extremely high price in the EU;

Amendment 143 #

Motion for a resolution
Recital J a (new)

Ja. whereas current EU legislation requires the demonstration of efficacy, safety and pharmaceutical quality before a new medicine can be authorized to enter the market; whereas despite this fact adverse drug reactions (ADR) are responsible for 3-10% of hospital admissions and the fifth most frequent cause of death;

Amendment 144 #

Herbert DORFMANN

Motion for a resolution
Recital J a (new)

Ja. whereas certain medicines are not available in some Member States, which can lead to problems with regard to patient care, particularly for patients living in a Member State other than their usual Member State of residence;

Amendment 145 #

Motion for a resolution
Recital J a (new)

Ja. whereas the Regulation on advanced therapy medicinal products was introduced to promote EU-wide innovation in this area while ensuring safety, but only eight novel therapies have been approved to date;

Amendment 146 #

Motion for a resolution
Recital J a (new)

Ja. whereas a shortage of essential medicines is a common problem in the majority of Member States and particularly affects hospitals, along with antibiotics and cancer, emergency and cardiovascular treatments;

Amendment 147 #

György HÖLVÉNYI, Miroslav MIKOLÁŠIK

Motion for a resolution
Recital J a (new)

Ja. whereas the European Medicines Agency launched a pilot project in 2014 known as 'adaptive pathways' which sought to provide access for patients to new medicines, by gathering evidence through real-life use to supplement clinical trials

Amendment 148 #

Motion for a resolution
Recital J a (new)

Ja. Whereas the European Parliament has shown its strong political commitment to this matter, above all by opening its current legislature to a more open policy for access to medicines;

Amendment 15 #

Motion for a resolution
Citation 5 a (new)

- having regard to the Report of the United Nations Secretary-General's High Level Panel on access to medicines – Promoting innovation and access to health technologies – published in September 2016;

Amendment 150 #

Motion for a resolution
Recital J a (new)

Ja. whereas Regulation 141/2000/EC on orphan medicinal products provides extra incentives to develop medicine for medicine for patients with rare diseases;

Amendment 151 #

Motion for a resolution
Recital J a (new)

Ja. whereas the composition of the medicinal products varies across countries and this leads to a discrepancy among medicinal products in the Member States

Amendment 152 #

Motion for a resolution
Recital J b (new)

Jb. whereas people living with disabilities, as well as those with long term illnesses that are not life threatening but do hamper and hinder quality of life and make everyday living more difficult than for a person in full health, are the most vulnerable and need medicines the most;

Amendment 153 #

Motion for a resolution
Recital J b (new)

Jb. whereas while no definition has been adopted in the EU on access to drugs, the WHO provided a definition in ‘Access to new medicines in Europe: technical review of policy initiatives and opportunities for collaboration and research’ (Copenhagen, 2015)

Amendment 154 #

Motion for a resolution
Recital J b (new)

Jb. whereas parallel trade of medicinal products lead to excessive medicines outflow from member states where lower prices are applied.

Amendment 155 #

Motion for a resolution
Recital J b (new)

Jb. Whereas to date the EU has not had a strategic plan for combating HCV;

Amendment 157 #

Motion for a resolution
Paragraph 1

1. Recalls that the EU pharmaceutical industry is one of the most competitive industries in Europe ~~and that~~; stresses that preserving a high quality of innovation is key to ~~improving its competitiveness~~continue addressing patients' needs and to improve the competitiveness of the pharmaceutical industry;

Amendment 158 #

Motion for a resolution
Paragraph 1

1. Recalls that the EU pharmaceutical industry is one of the most competitive industries in Europe and that quality, safety and efficacy of innovation isare key to improving its competitiveness;

Amendment 159 #

Lieve WIERINCK, Gesine MEISSNER, Frédérique RIES, José Inácio FARIA, Marian HARKIN, Jana TOOM, Jasenko SELIMOVIC

Motion for a resolution
Paragraph 1

1. Recalls that the EU pharmaceutical industry is one of the most competitive and strategic industries in Europe and that quality innovation is key to improving its competitiveness;

Amendment 16 #

Motion for a resolution
Citation 5 a (new)

- having regard to the September 2016 United Nations Secretary-General's High-Level Panel on Access to Medicines Report on Promoting Innovation and Access to Health Technologies

Amendment 160 #

Motion for a resolution
Paragraph 1 a (new)

1a. Shares the concern expressed in the 2016 Council Conclusions on strengthening the balance in the pharmaceutical systems in the EU and its Member States, acknowledging an imbalance in the national pharmaceutical systems in the EU due to complex interactions between measures to promote innovation and the assessment of medicinal products, and pricing and reimbursement decisions at national level leading to suboptimal outcomes for patients and society;

Amendment 161 #

Motion for a resolution
Paragraph 1 a (new)

1a. Recalls that under Article 168 of the Treaty on the Functioning of the European Union, a high level of human health protection shall be ensured in the definition and implementation of all Union policies and activities

Amendment 162 #

Frédérique RIES, Françoise GROSSETÊTE

Motion for a resolution
Paragraph 1 a (new)

1a. Stresses the importance of medicines in improving public health enabling patients to live longer and better lives, thereby supporting the productivity of our societies and economic growth.

Amendment 163 #

Motion for a resolution
Paragraph 1 a (new)

1a. Stresses that in a European Union which is suffering deindustrialisation, the pharmaceutical sector remains an important industrial pillar and a driving force for job creation;

Amendment 164 #

Mireille D'ORNANO, Jean-François JALKH, Sylvie GODDYN

Motion for a resolution
Paragraph 1 a (new)

1a. Stresses that the pharmaceutical industry creates some 800 000 jobs in the European Union;

Amendment 165 #

Mireille D'ORNANO, Jean-François JALKH, Sylvie GODDYN

Motion for a resolution
Paragraph 1 b (new)

1b. Stresses, however, that almost 80% of the European pharmaceutical industry’s ingredients for new active substances are imported, above all, from India and China, and that its dependence on imports threatens the self-sufficiency of the European Union and its Member States and, in the long term, European consumers’ health;

Amendment 166 #

Lieve WIERINCK, Gesine MEISSNER, Frédérique RIES, José Inácio FARIA, Ulrike MÜLLER, Jasenko SELIMOVIC

Motion for a resolution
Paragraph 2

~~2. Regrets that the research priorities of the pharmaceutical industry are profit- oriented rather than patient-orien~~deleted;

Amendment 167 #

Motion for a resolution
Paragraph 2

~~2. Regrets that the research priorities of the pharmaceutical industry are profit- oriented rather than patient-orien~~deleted;

Amendment 168 #

Motion for a resolution
Paragraph 2

2. ~~Regret~~Notes that the ~~research priorities of the pharmaceutical industry are profit- oriented rather than patient-oriented~~employees of pharmaceutical companies are primarily interested in medical progress and the well-being of patients, but that pharmaceutical companies ultimately want to make a profit , which means that the political framework has to create the best possible outcome for patients and the general public;

Amendment 169 #

Motion for a resolution
Paragraph 2

2. Re~~gre~~quests that the research priorities of the pharmaceutical industry ~~are profit- oriented rather than patient-or~~be consistently oriented towards making European production competitive as well as sustainable and affordable for the patiented;

Amendment 17 #

Motion for a resolution
Citation 5 a (new)

- having regard to the Council’s conclusions on innovation for the benefit of patients of 1 December 2014 1c, __________________ 1c http://www.consilium.europa.eu/uedocs/c ms_data/docs/pressdata/en/lsa/145978.pdf

Amendment 171 #

Motion for a resolution
Paragraph 2

2. Regrets that the research priorities of the pharmaceutical industry are profit- oriented rather than patient-oriented and condemns the EU’s position in having turned medicine from a public good into a commodity;

Amendment 172 #

Mireille D'ORNANO, Jean-François JALKH, Sylvie GODDYN

Motion for a resolution
Paragraph 2

2. Regrets that as long as medicines are considered to be regular consumer goods, unresolved policy incoherencies between trade and intellectual property rules, public health objectives and international human rights lead to a situation where the research priorities of the pharmaceutical industry are profit- oriented rather than patient-oriented;

Amendment 173 #

Motion for a resolution
Paragraph 2

2. Regrets that the research priorities of the pharmaceutical industry are profit- oriented rather than patient-oriented; points out that public health as a domain can sometimes be irrational; some general and expensive screenings are passing fads, rather than proper, effective screenings, and screenings targeted according to risk and followed up with more comprehensive examinations would be more appropriate;

Amendment 174 #

Françoise GROSSETÊTE, Frédérique RIES, Elisabetta GARDINI, Cristian-Silviu BUŞOI

Motion for a resolution
Paragraph 2

2. ~~Regret~~Notes that the research priorities of the pharmaceutical industry ~~are profit- oriented rather than patient-oriented~~reflect a balance between patient medical needs and the likelihood of generating the return on investment necessary to continue investing in future innovation;

Amendment 175 #

Motion for a resolution
Paragraph 2

2. ~~Regret~~Notes that the research priorities of the pharmaceutical industry ~~are profit- oriented rather than patient-oriented~~encompass ensuring better treatment for patients and generating financial returns;

Amendment 176 #

José Inácio FARIA, Jasenko SELIMOVIC, Marian HARKIN, Jana TOOM

Motion for a resolution
Paragraph 2 a (new)

2a. Notes with concern an increasing number of examples of market failure in a number of Member States, where patients access to effective and affordable essential medicines is endangered by very high and unsustainable price levels, market withdrawal of products that are out-of- patent or when new products are not introduced to national markets for business economic strategies, and that individual governments have sometimes limited influence in such circumstances;

Amendment 177 #

Motion for a resolution
Paragraph 2 a (new)

2a. Notes that over 7000 innovate medicines are in the development pipeline with much expected therapeutic benefit for patients; considers that some current pricing strategies for innovative medicines and their combined budgetary impact pose a threat to the sustainability of health care systems and therefore might not be accessible for those who need it;

Amendment 178 #

Motion for a resolution
Paragraph 2 a (new)

2a. Deplores the fact that there are 18 million people across the EU without access to health care; also finds it alarming that in a period of relative prosperity with many advances in healthcare, medicines and technology, there appears to be very little advancement in creating sustainable solutions for those without healthcare or medicines;

Amendment 179 #

Motion for a resolution
Paragraph 2 a (new)

2a. Criticises the fact that health expenses continue to be seen only as a cost and not as an investment, and that medicine is always the first variable in economic measures in our healthcare systems;

Amendment 18 #

Motion for a resolution
Citation 5 a (new)

- having regard the Council Conclusions of European Health Minister of 16 April 2016

Amendment 180 #

Mireille D'ORNANO, Jean-François JALKH, Sylvie GODDYN

Motion for a resolution
Paragraph 2 a (new)

2a. Stresses that patients' organizations should be better involved in the definition of private and public clinical trials research strategies, to ensure that they meet the true unmet needs of the European patients;

Amendment 181 #

Motion for a resolution
Paragraph 2 a (new)

2a. Points out that the costs of research and development activities are difficult to assess because of the experimental nature inherent in scientific research;

Amendment 182 #

Motion for a resolution
Paragraph 2 a (new)

2a. whereas spending on R&D and private research efforts is important to discovering new treatments and the economic growth of the EU;

Amendment 183 #

Motion for a resolution
Paragraph 2 a (new)

2a. Notes that the research priorities of pharmaceutical industry have to address health patient needs.

Amendment 184 #

José Inácio FARIA, Jasenko SELIMOVIC, Marian HARKIN, Jana TOOM

Motion for a resolution
Paragraph 2 b (new)

2b. Points outs that although pharmaceutical companies often argue that their R+D costs are prohibitively expensive, data shows that these companies' spend on marketing actually far outstrips R+D costs

Amendment 185 #

Motion for a resolution
Paragraph 2 b (new)

2b. Notes with concern the recent scientific trends that lead to investments being steered to low volume, high priced medicines, leaving other important areas neglected;

Amendment 186 #

José Inácio FARIA, Marian HARKIN, Jana TOOM

Motion for a resolution
Paragraph 2 c (new)

2c. Notes that in a context of highly priced medicines in the innovative pharmaceutical sector, market research data show that R&D investment is often substantially lower than sales and marketing expenditure; Highlights the fact that this puts at risk the sustainability of European healthcare systems and indicates the persistence of inappropriate market rewards which should be corrected;

Amendment 187 #

José Inácio FARIA, Jasenko SELIMOVIC, Marian HARKIN, Jana TOOM

Motion for a resolution
Paragraph 2 d (new)

2d. Calls on Member States to build on the example of existing initiatives in Europe to place negative incentives on the marketing expenditure by the pharmaceutical industry such as a contribution system towards an innovation fund aimed at promoting independent research in areas of interest for the National Health Services that are insufficiently addressed by commercial research, (e. g. antimicrobial resistance), and for patient populations normally excluded by clinical studies such as children, pregnant women and the elderly;

Amendment 188 #

Lieve WIERINCK, Gesine MEISSNER, Marian HARKIN, Ulrike MÜLLER, Jana TOOM, Jasenko SELIMOVIC

Motion for a resolution
Paragraph 3

3. Stresses that more transparency ofin the ~~cost of development and clinical trials is crucial in order to set a fair price;~~ proportion of publicly funded research is needed, and that when assessing the total cost of a drug, it is necessary to take into account the costs for research and development, including research failures and clinical trials, and the whole pharmaceutical value chain;

Amendment 189 #

Motion for a resolution
Paragraph 3

~~3. Stresses that transparency of the cost of development and clinical trials is crucial in order to set a fair price;~~deleted

Amendment 19 #

Mireille D'ORNANO, Jean-François JALKH, Sylvie GODDYN

Motion for a resolution
Citation 5 b (new)

- having regard the Council Conclusions of 10 may 2006 on Common Values and Principles in EU Health Systems; the Council Conclusions of European Health Minister of 6 April 2011 and of 10 December 2013 on Health Systems Adequate and Sustainable

Amendment 190 #

Motion for a resolution
Paragraph 3

3. Stresses that transparency of the cost of development and clinical trials is crucial in order to set a fair price, as indicated in Directive 89/105;

Amendment 192 #

Motion for a resolution
Paragraph 3

3. Stresses that transparency of the cost of development and clinical trials, whether ex ante or ex post, is crucial in order to set a fair price;

Amendment 193 #

Motion for a resolution
Paragraph 3

3. Stresses that full transparency of the cost of ~~development and~~research and development, including clinical trials is crucial in order to set a fair price;

Amendment 194 #

Motion for a resolution
Paragraph 3

3. Stresses that transparency of the cost of development of medicines and clinical trials is crucial in order to set a fair price;

Amendment 195 #

Elisabetta GARDINI, Cristian-Silviu BUŞOI, Alojz PETERLE, Françoise GROSSETÊTE, Giovanni LA VIA, Aldo PATRICIELLO, Alessandra MUSSOLINI

Motion for a resolution
Paragraph 3

3. Stresses that full transparency of the cost of ~~development~~R&D and clinical trials is crucial in order to set a fair price;

Amendment 196 #

Motion for a resolution
Paragraph 3 a (new)

3 a. Stresses that patients' organisations should be better involved in the definition of private and public clinical trials research strategies, to ensure that they meet the true unmet needs of European patients;

Amendment 197 #

José Inácio FARIA, Jasenko SELIMOVIC, Anneli JÄÄTTEENMÄKI, Marian HARKIN, Jana TOOM

Motion for a resolution
Paragraph 3 a (new)

3a. Stresses that marketing cost contribute to the price of medicines to a much higher extent than R&D costs.

Amendment 198 #

Motion for a resolution
Paragraph 3 a (new)

3a. Recalls that robust clinical trials are necessary to assess the efficacy and safety of medicines;

Amendment 199 #

Motion for a resolution
Paragraph 4

~~4. Stresses that the interests of the pharmaceutical industry favour short trials and fast access to the market;~~deleted

Amendment 2 #

Motion for a resolution
Citation 1 a (new)

- having regard to the Commission REFIT evaluation of the Council Regulation (EC) 953/2003 to avoid trade diversion into the European Union of certain key medicines (SWD(2016) 125 final})

Amendment 20 #

Motion for a resolution
Citation 5 c (new)

- having regard the Commission Communication on Effective, Available and Robust Health Systems of 4 April 2014 (COM(2014/215))

Amendment 200 #

Motion for a resolution
Paragraph 4

4. Stresses that the ~~interests of~~short trials that allow the pharmaceutical industry fa~~vour short trials~~st access to the market must always be the exception and not the rule for authorising new medicines, must not be motivated by commercial considerations, and famust ~~access~~never sacrifice the rights guaranteed to the mpar~~ket~~ticipants of clinical trials;

Amendment 202 #

Andrey KOVATCHEV, Cristian-Silviu BUŞOI, Kateřina KONEČNÁ

Motion for a resolution
Paragraph 4

4. Stresses that ~~the interests of the pharmaceutical industry~~, as trade and intellectual property rules were not developed with the goal of protecting the right to health, the interests of private patent holders favour short trials and fast access to the market;

Amendment 203 #

Motion for a resolution
Paragraph 4

4. Stresses that ~~the interests of the pharmaceutical industry favour short trials and fast access to the market~~, especially in case of unmet needs, the interests of patients favour more efficient trials and fast access to safe and effective medicines;

Amendment 204 #

Lieve WIERINCK, Gesine MEISSNER, Marian HARKIN, Ulrike MÜLLER, Jana TOOM, Jasenko SELIMOVIC

Motion for a resolution
Paragraph 4

4. Stresses that it is in the interests of the pharmaceutical industry ~~favour short trials and~~and patients to ensure fast access to the market for innovative medicines both in-patent and off-patent;

Amendment 205 #

Françoise GROSSETÊTE, Frédérique RIES, Elisabetta GARDINI, Cristian-Silviu BUŞOI

Motion for a resolution
Paragraph 4

4. ~~Stress~~Notes that the interests of the pharmaceutical industry favour short trials and fast access to the market; stress however the importance to prefer robust clinical trials in order to better assess the efficacy and safety of medicines;

Amendment 206 #

Motion for a resolution
Paragraph 4

4. Stresses that, in case of unmet medical needs, the interests of the patients and the pharmaceutical industry ~~favour~~may require short trials and fast access to the market;

Amendment 207 #

Motion for a resolution
Paragraph 4

4. Stresses that the interests of the pharmaceutical industry favour short trials and fast access to the market; but recalls that clinical trials are necessary to assess the efficacy and safety of medicines;

Amendment 208 #

Motion for a resolution
Paragraph 4

4. Stresses that the interests of the pharmaceutical industry favour short trials and fast access to the market, for example, adaptive licensing;

Amendment 209 #

Motion for a resolution
Paragraph 4

4. Stresses that the interests of the pharmaceutical industry in the Union favour short trials and fast access to the market;

Amendment 21 #

José Inácio FARIA, Jasenko SELIMOVIC, Frédérique RIES, Lieve WIERINCK, Jana TOOM

Motion for a resolution
Citation 5 d (new)

- having regard to the Commission report on Towards Harmonised EU Assessment of Added therapeutic Value of Medicines

Amendment 210 #

Motion for a resolution
Paragraph 4 a (new)

4a. Notes the fragmentation of the pharmaceutical market in the EU and acknowledges the increased administrative burdens and the higher costs that it implies for industry; Highlights that this is an obstacle to the sector's competitiveness and to the expansion of spin-off and young companies seeking to enter the market, pulling away from Europe investment in this innovative sector; Stresses that such barriers bring important delays to patients' access to new medicines;

Amendment 211 #

Lieve WIERINCK, Gesine MEISSNER, Frédérique RIES, Marian HARKIN

Motion for a resolution
Paragraph 4 a (new)

4a. Stresses that the fast-tracking of medicines and the circumvention of the standard risk assessment for licensing a medicine should not become the norm and must be restricted to only a very select number of medicines, for which an objective need must be clearly met. Calls therefore on the European Commission and the European Medicines Agency to precisely define unclear terms upon which the adaptive pathways mechanism is based such as 'unmet medical need'

Amendment 212 #

Motion for a resolution
Paragraph 4 a (new)

4a. Welcomes the adaptive pathways pilot project and the PRIME scheme by the European Medicines Agency as a way to ensure timely access to medicines for patients with unmet medical needs, without compromising on patient safety;

Amendment 213 #

Motion for a resolution
Paragraph 4 a (new)

4a. Underlines the role of European research projects and SMEs in improving the access to medicines at the European level, highlights the role of Horizon 2020 programme in this respect.

Amendment 214 #

Motion for a resolution
Paragraph 4 a (new)

4a. Note with concerns that industry 'interactions with health-sector stakeholders are poorly regulated, which may lead to conflict of interest and biased decisions;

Amendment 215 #

José Inácio FARIA, Jasenko SELIMOVIC, Frédérique RIES, Marian HARKIN, Lieve WIERINCK, Jana TOOM

Motion for a resolution
Paragraph 4 b (new)

4b. Calls on Member States to develop closer collaboration to fight such market fragmentation, namely to develop shared Health Technology Assessment processes and results, and to work on shared criteria to instruct price and reimbursement decisions at national level;

Amendment 216 #

Motion for a resolution
Paragraph 4 b (new)

4b. Notes with concern that 5% of all hospital admissions in the EU are due to an adverse drug reaction (ADR) and ADRs are the 5th leading cause of hospital death

Amendment 217 #

Motion for a resolution
Paragraph 4 c (new)

4c. Highlights the concern expressed by healthcare professionals, civil society organisations and regulators that adaptive pathways which rely on limited preliminary clinical data, surrogate outcomes and observational studies risk incorrect conclusions on the benefit-harm of new drugs; regrets the approach of the EMA in this regard

Amendment 218 #

Motion for a resolution
Paragraph 4 d (new)

4d. Notes with concern that a central element of the adaptive pathways mechanism is reliance upon 'real world data' i.e. observational data instead of data gathered during clinical trials

Amendment 219 #

Motion for a resolution
Subheading 2 a (new)

Points out that innovation should help to improve people’s quality of life by solving their health problems, along with other challenges such as the sustainability of the health systems, and that, in any case, it should not be a factor of inequality in health;

Amendment 22 #

Motion for a resolution
Citation 5 e (new)

- having regard to the Report of WHO Expert Committee "Selection of Essential Drugs" (Geneve 1977) and the review of Geneva of 7 December 2001 (EB109/8); and 2015; and the WHO report on Access to new medicines in Europe (March 2015); and the WHO Report on Priority Medicines for Europe and the world of 28 June 2013

Amendment 220 #

José Inácio FARIA, Jasenko SELIMOVIC, Anneli JÄÄTTEENMÄKI, Frédérique RIES, Marian HARKIN, Lieve WIERINCK, Jana TOOM

Motion for a resolution
Subheading 2 a (new)

Emphasises that research and innovation is crucial for Europe´s growth and development; on health must be focused on safe, qualitative sustainable and affordable medicines.

Amendment 221 #

Motion for a resolution
Paragraph 4 c (new)

4c. Considers innovation in the pharmaceutical sector to be crucial in order to address unmet medical needs;

Amendment 222 #

Motion for a resolution
Subheading 2 b (new)

Recalls intellectual property grants companies the right to a legal monopoly that need to be regulated to avoid the conflict with the right to health protection and that can be compatible with the quality of innovation, competitiveness or public interest

Amendment 223 #

Françoise GROSSETÊTE, Karl-Heinz FLORENZ, Frédérique RIES, Elisabetta GARDINI, Cristian-Silviu BUŞOI

Motion for a resolution
Paragraph 5

5. Recalls that IP rights allows a l~~egal monopol~~imited period of exclusivity, which needs to be carefully regulated to ~~avoid conflict with the right to health protection and to~~ promote quality of innovation and competitiveness;

Amendment 224 #

Motion for a resolution
Paragraph 5

5. Recalls that IP rights ~~allow a legal monopoly, which needs to be carefully regulated~~provide a limited period of exclusivity, which is carefully regulated and monitored by the authorities to avoid conflict with the right to health protection and to promote quality of innovation and competitiveness;

Amendment 225 #

Lieve WIERINCK, Gesine MEISSNER, Marian HARKIN, Jana TOOM

Motion for a resolution
Paragraph 5

5. Recalls that IP rights allow a legal monopoly, which needs to be carefully regulated to avoid conflict with the right to health protection ~~and to promote quality of innovation and competitiveness~~; calls on the competent authorities to carefully apply the principle of the originality of patents, and to therefore avoid pandering to the market strategy (by always giving patents the green light) of pharmaceutical companies to keep a patent for a medicine for as long as possible by making non-essential changes, for example by adding bulking agents, to be able to continue holding the monopoly over that medicine;

Amendment 227 #

5a. To this effect, asks the Commission to commit itself to carrying out an analysis of the patent system for medicines, in particular to check whether patents for medicines obstruct innovation and the movement of products in delicate and non-competitive sectors, such as the treatment of rare diseases;

Amendment 23 #

Motion for a resolution
Citation 5 f (new)

- having regard to the Regulation (EC 141/2000) on Orphan Medicinal Products

Amendment 230 #

Lieve WIERINCK, Gesine MEISSNER, Frédérique RIES, José Inácio FARIA, Marian HARKIN, Ulrike MÜLLER, Jana TOOM, Jasenko SELIMOVIC

Motion for a resolution
Paragraph 5 a (new)

5a. Recognises that a balanced and strong, functioning and effective intellectual property environment, that is line with international commitments of the European Union, is important for supporting and promoting access to innovative, safe, effective and quality medicinal products in the European Union;

Amendment 231 #

Motion for a resolution
Paragraph 5 a (new)

5a. Stresses that research and development is essential to address unmet medical needs, and should be thus incentivized accordingly, to ensure best treatments for patients, and to enhance socio-economic value through job creation and knowledge clusters.

Amendment 232 #

Motion for a resolution
Paragraph 6

~~6. Emphasises that most medicines are not examples of genuine innovation, but often ‘me-too’ or ‘evergreening’ products, which are permitted notably by complementary patent extensions;~~deleted

Amendment 233 #

José Inácio FARIA, Jasenko SELIMOVIC, Marian HARKIN, Jana TOOM

Motion for a resolution
Paragraph 6

Amendment 234 #

Motion for a resolution
Paragraph 6

6. ~~Emphasises that most medicines are not examples of genuine innovation, but often ‘me-too’ or ‘everg~~Recalls that incremental innovation for patented molecules such as repurposing, reformulation and the development of new medicines for the same indication ("me-too" substances) may offer incremen~~ing’ products, whic~~tal value to patients, to patients sub-groups and to health care ~~permitted notably by complementary patent extension~~systems; believes that the added value of such medicines should be carefully assessed and measurable benefits should be demonstrated prior to price and reimbursement decisions; warns against the potential misuse of IP protection rules allowing for the "evergreening" of patent rights;

Amendment 235 #

Elisabetta GARDINI, Cristian-Silviu BUŞOI, Alojz PETERLE, Giovanni LA VIA, Aldo PATRICIELLO, Alessandra MUSSOLINI

Motion for a resolution
Paragraph 6

6. Emphasises that ~~most~~new medicines ~~are not examples of genu~~bringineg in~~novation, but often ‘me-too’ or ‘evergreening’ products, which are permitted notably by complementary patent extens~~sufficient added clinical value do not provide genuine innovations;

Amendment 236 #

Motion for a resolution
Paragraph 6

Amendment 237 #

Motion for a resolution
Paragraph 6

6. Emphasises that most medicines are not examples of genuine innovation, but often ‘me-too’ or ‘evergreening’ products, which are permitted notably by complementary patent extensions; calls on the Commission to propose measures for limiting this phenomenon to the Member States;

Amendment 239 #

Motion for a resolution
Paragraph 6

6. Emphasises that m~~ost~~any medicines are not examples of genuine innovation, but often ‘me-too’ or ‘evergreening’ products, which are permitted notably by complementary patent extensions;

Amendment 24 #

Motion for a resolution
Citation 5 g (new)

- having regard to Articles 168(1), (2), (4) and (7) TFEU on the EU’s health competences,

Amendment 240 #

Lieve WIERINCK, Gesine MEISSNER, Frédérique RIES, José Inácio FARIA, Marian HARKIN, Jana TOOM, Jasenko SELIMOVIC

Motion for a resolution
Paragraph 6 a (new)

6a. Recognises that medical innovation is also coming from known off-patent molecules through finding new indications, drug reformulations or new innovative combinations and stresses the importance to deliver to patients more customized treatments delivering better efficacy, less side effects, better adherence and better quality of life, to avoid disease exacerbations and costly therapeutic escalations;

Amendment 241 #

Motion for a resolution
Paragraph 6 a (new)

6a. Contests the adequacy of secondary patenting where marginal or insignificant changes in therapeutic effect are observed;

Amendment 242 #

Lieve WIERINCK, Gesine MEISSNER, Frédérique RIES, Jasenko SELIMOVIC

Motion for a resolution
Paragraph 7

~~7. Stresses that the high level of public funds used for R&D is not ref~~delected ~~in the pricing;~~

Amendment 243 #

Motion for a resolution
Paragraph 7

~~7. Stresses that the high level of public funds used for R&D is not ref~~delected ~~in the pricing;~~

Amendment 244 #

Motion for a resolution
Paragraph 7

7. Stresses that the high level of public funds used for R&D is not reflected in the pricing; underlines the need to require full transparency and public disclosure of research and development costs when EU funds are invested in the development of new medicines

Amendment 245 #

Motion for a resolution
Paragraph 7

~~7. Stresses that the high level of public funds used for R&D is not ref~~delected ~~in the pricing;~~

Amendment 246 #

Mireille D'ORNANO, Jean-François JALKH, Sylvie GODDYN

Motion for a resolution
Paragraph 7

7. Stresses that the high level of public funds used for R&D is not reflected in the pricing due to the lack of traceability of the public funds in the patenting and licensing conditions, impeding a fair public return on public investment;

Amendment 247 #

Motion for a resolution
Paragraph 7

7. Stresses that the high level of public funds used for R&D is not always reflected in the ~~pricing~~final price of medicines;

Amendment 248 #

Motion for a resolution
Paragraph 7

7. Stresses that the ~~high~~ level of public funds used for R&D is not reflected in the pricing;

Amendment 249 #

Motion for a resolution
Paragraph 7 a (new)

7a. Calls on the Commission to set out a clear definition on added value drugs, as taking that step could result in an increase in R&D investment in Europe;

Amendment 25 #

Motion for a resolution
Citation 5 h (new)

- having regard to the Article 35 of the Charter of Fundamental Rights in the EU and the article 6(1) TEU on right to health protection for European citizens,

Amendment 250 #

Jytte GUTELAND

Motion for a resolution
Paragraph 7 a (new)

7a. Recalls that inequalities between women and men persist in national health systems; stresses the important role of the pharmaceutical industry and national health authorities in ensuring that medicinal research and development does not discriminate diseases where a majority of patients are women.

Amendment 251 #

Motion for a resolution
Paragraph 7 a (new)

7a. Stresses that the provisions in 141/2000/EC should only be applicable for rare diseases, when a substantial development has taken place and other best alternatives are not already available; the legislation should not be misused for driving up prices;

Amendment 252 #

Motion for a resolution
Paragraph 7 a (new)

7a. Highlights the need for greater transparency in communicating research and development costs to the public, above all when public funds, whether these are from the EU or elsewhere, are invested in the development of new medicines.

Amendment 254 #

Motion for a resolution
Paragraph 7 a (new)

7a. Recalls that the WTO TRIPS Agreement provides for flexibilities to patent rights, such as compulsory licensing, which have proven to be a major tool to introduce competition and bring prices to reasonable levels;

Amendment 255 #

Motion for a resolution
Paragraph 7 b (new)

7b. Calls on the Commission to set up an EU easily searchable and regularly updated database on the flexibilities to patent rights requested/used in Member States and on filed patent oppositions and the outcome thereof;

Amendment 256 #

Frédérique RIES, Françoise GROSSETÊTE

Motion for a resolution
Paragraph 7 b (new)

7b. Emphasises that medicinal product innovation, in both molecules and simplification to improve adherence, may boost the public finances of European public health systems;

Amendment 257 #

Motion for a resolution
Paragraph 8

8. ~~Deplores the large number of litigation cases aiming~~Stresses the importance of having generic medicines and biosimilar medicines in good time in order to dhel~~ay generic entry;~~p patients to access pharmaceutical therapies,

Amendment 258 #

Motion for a resolution
Paragraph 8

8. Deplores the large number of litigation cases ~~aiming to delay generic entry~~that delay generic entry; according to the Commission’s report on the pharmaceutical sector published in 2008, the number of litigation cases quadrupled between 2000 and 2007, almost 60% of the cases concerned second generation patents and on average they took two years to be resolved;

Amendment 259 #

Motion for a resolution
Paragraph 8

8. ~~Deplor~~Notes the large number of litigation cases ~~aiming to delay~~on generic ~~entry~~s;

Amendment 26 #

Motion for a resolution
Citation 5 i (new)

- having regard to Articles 101 and 102 TFEU laying down rules on competition,

Amendment 260 #

Motion for a resolution
Paragraph 8

8. ~~Deplore~~Condemns the large number of litigation cases aiming to delay generic entry;

Amendment 261 #

Motion for a resolution
Paragraph 8

8. Deplores the ~~large number of~~ litigation cases aiming to delay generic entry;

Amendment 262 #

José Inácio FARIA, Jasenko SELIMOVIC, Marian HARKIN, Jana TOOM

Motion for a resolution
Paragraph 8 a (new)

8a. Stresses that the development of generic and biosimilar medicines is often the only way to allow poorer parts of the population access pharmaceutical products;

Amendment 263 #

Motion for a resolution
Paragraph 9

9. Stresses that better regulation will promote competitiveness; also recognises the importance and effectiveness of antitrust tools against anti-competitive behaviours such as the abuse or misuse of patent systems and of the system for authorisation of medicines, in violation of Articles 101 and/or 102 of the TFEU; calls on the Commission to carry out an in- depth analysis of the existing Intellectual Property legislation in the pharmaceutical sector with a focus on divergent interpretation and litigation cases and, where necessary, to bring forward a legislative review to ascertain legal clarity and the correct implementation and use of legal provisions in order to safeguard legitimate intellectual property and patent rights, as well as public interest;

Amendment 264 #

José Inácio FARIA, Jasenko SELIMOVIC, Anneli JÄÄTTEENMÄKI, Marian HARKIN, Jana TOOM

Motion for a resolution
Paragraph 9 a (new)

9a. Calls on the Commission to revise the Transparency Directive with a focus on guaranteeing timely entry into the market for generic and biosimilar medicines, ending patent linkage according to Commission's guidelines, accelerating pricing and reimbursement decisions for generics and precluding the multiple reassessment of the elements supporting marketing authorisation; Believes that this will maximise savings for national health budgets, improve affordability, accelerate patient access and prevent administrative burdens for generic and biosimilar companies;

Amendment 265 #

Mireille D'ORNANO, Jean-François JALKH, Sylvie GODDYN

Motion for a resolution
Paragraph 9 a (new)

9a. Points out that biosimilar medicines may provide savings for health systems and help to improve access to medicines for patients, for which their added value and efficiency in the system should be taken into account, their potential impact should analysed and, where appropriate, measures to support their introduction into the market should be studied;

Amendment 266 #

Motion for a resolution
Paragraph 9 a (new)

9a. Stresses, nevertheless, that with regard to the free movement of goods and, in the case in point, of pharmaceutical products, among the Member States, pharmaceutical products imported from another Member State now represent some 30% of sales of pharmaceutical products in the European Union;

Amendment 267 #

Mireille D'ORNANO, Jean-François JALKH, Sylvie GODDYN

Motion for a resolution
Paragraph 9 a (new)

9a. Deplores that a number of drugs shortages occur because of unfair business economic strategies such as "pay for delay" in the pharmaceutical sector;

Amendment 268 #

Motion for a resolution
Paragraph 9 b (new)

9b. Stresses that this significant share of pharmaceutical products moved between Member States on the European pharmaceutical product markets (hereafter ‘parallel trade’) does not lower or level the costs of pharmaceutical products in the European Union and that, on the other hand, the consequence of this parallel trade has been a rise in the number of counterfeit pharmaceutical products recorded in the European Union, and it therefore poses a significant health risk to consumers;

Amendment 269 #

José Inácio FARIA, Jasenko SELIMOVIC, Marian HARKIN, Jana TOOM

Motion for a resolution
Paragraph 9 b (new)

9b. Calls on the Commission to monitor regularly patent settlement agreements that may restrict generic market entry into the market in exchange for benefits transferred from the originator to the generic company;

Amendment 27 #

José Inácio FARIA, Jasenko SELIMOVIC, Frédérique RIES, Marian HARKIN, Lieve WIERINCK

Motion for a resolution
Citation 5 j (new)

- having regard the article 81 of Directive 2001/83/EC on shortages provisions

Amendment 270 #

Motion for a resolution
Paragraph 9 c (new)

9c. Calls on the Commission to introduce a Supplementary Protection Certificate (SPC) manufacturing waiver to Regulation 469/2009 allowing the production of generic and biosimilar medicines in Europe, with the purpose of exporting them to countries without SPCs or where these have expired earlier, without undermining the exclusivity granted under the SPC regime in protected markets; believes that such provisions could have a positive impact on access to high quality medicines in developing and least developed countries and on increasing manufacturing and R&D in Europe, creating new jobs and stimulating economic growth;

Amendment 271 #

Mireille D'ORNANO, Jean-François JALKH, Sylvie GODDYN

Motion for a resolution
Paragraph 9 c (new)

9c. Stresses that for the reasons outlined in paragraphs 9a and 9b of this text, it is important to regulate the parallel trade of pharmaceutical products;

Amendment 272 #

José Inácio FARIA, Anneli JÄÄTTEENMÄKI, Marian HARKIN, Jana TOOM

Motion for a resolution
Paragraph 9 d (new)

9d. Highlights that some Member States have achieved particularly low prices by the use of large-scale tendering in generic medicines; Notes with concern that excessive focus on short-term cost- savings may lead to medium- and long- term unintended consequences such as market concentration in the generic industry, and increased risk of shortages due to lack of redundancy in the system and lack of financial motivation to produce low-profit margin medicines, as well as low-volume drugs;

Amendment 273 #

José Inácio FARIA, Jasenko SELIMOVIC, Jana TOOM

Motion for a resolution
Paragraph 9 e (new)

9e. Highlights that value-based pricing of medicines can be misused as a profit- maximization economic strategy, which in that case leads to the setting of prices that are disproportionate to its cost structure, regardless of an optimal distribution of social welfare

Amendment 274 #

José Inácio FARIA, Marian HARKIN, Jana TOOM

Motion for a resolution
Paragraph 9 f (new)

9f. Considers that pricing and reimbursement decisions need to consider the added value of innovative medicines while avoiding unilateral appropriation of such value; stresses that new and fairer pricing models should aim at shared and balanced stakeholder benefit, by ensuring payers' sustainability, patients' health gains and proportionate industry profits;

Amendment 275 #

Elisabetta GARDINI, Cristian-Silviu BUŞOI, Alojz PETERLE, Giovanni LA VIA, Aldo PATRICIELLO, Alessandra MUSSOLINI

Motion for a resolution
Paragraph 10

10. Stresses that most national assessment agencies are already using clinical, economic and social benefit criteria to assess new drugs in terms of pricing and reimbursement and stresses the importance of increasing collaboration among Member States in the field of pricing and reimbursement of medicinal products to ensure sustainability of the healthcare systems and preserve the rights of the European citizens to access quality healthcare;

Amendment 276 #

Motion for a resolution
Paragraph 10

10. Stresses that most national assessment agencies are already using clinical, economic and social benefit criteria to assess new drugs in terms of pricing and reimbursement and stresses the importance of increasing collaboration among Member States in the field of pricing and reimbursement of medicinal products to ensure sustainability of healthcare systems and preserve the rights of European citizens to access quality healthcare;

Amendment 277 #

Motion for a resolution
Paragraph 10

10. Stresses that most national assessment agencies are already using a large and varied clinical, economic and social benefit criteria to assess new drugs in terms of pricing and reimbursement; to assess the added value of medicines to improve access to medicines and to preserve health systems sustainability.

Amendment 278 #

Mireille D'ORNANO, Jean-François JALKH, Sylvie GODDYN

Motion for a resolution
Paragraph 10

10. Stresses that most national assessment agencies are already using clinical, economic and social benefit criteria to ~~assess~~evaluate new drugs in ~~term~~order to support their decisions ofn pricing and reimbursement;

Amendment 279 #

Motion for a resolution
Paragraph 10 a (new)

10a. Stresses, however, that every Member State has its own evaluation criteria and methods for negotiating tariffs with the pharmaceutical industry, and that the pharmaceutical product tariff differentials between Member State amount to around 25%, and sometimes range from 1 to 16 for generic medicines;

Amendment 28 #

José Inácio FARIA, Anneli JÄÄTTEENMÄKI, Marian HARKIN, Jana TOOM

Motion for a resolution
Citation 5 k (new)

- having regard to the Doha Declaration on the TRIPS Agreement and Public Health (WTO/MIN(01/DEC/2) and Implementation of paragraph 6 of the DOHA Declaration of 1 September 2003 (WTO/L/540)

Amendment 280 #

Motion for a resolution
Paragraph 10 a (new)

10a. Notes with concern that data supporting the assessment of the added value of innovative medicines is often scarce and not sufficiently convincing to support solid decision making on pricing;

Amendment 281 #

Elisabetta GARDINI, Cristian-Silviu BUŞOI, Alojz PETERLE, Giovanni LA VIA, Alberto CIRIO, Aldo PATRICIELLO, Alessandra MUSSOLINI

Motion for a resolution
Paragraph 10 a (new)

10a. points out that competence for pricing and reimbursement decisions falls exclusively to Member States;

Amendment 282 #

Motion for a resolution
Paragraph 10 a (new)

10a. Recognises that pricing and reimbursement of medicinal products are competences of Member States;

Amendment 283 #

José Inácio FARIA, Jasenko SELIMOVIC, Anneli JÄÄTTEENMÄKI, Marian HARKIN, Jana TOOM

Motion for a resolution
Paragraph 10 b (new)

10b. Considers that independent and good quality evidence is crucial to determine the cost-effectiveness of new medicines;

Amendment 284 #

Motion for a resolution
Paragraph 10 c (new)

10c. Notes that more dynamic pricing models such as outcomes-based pricing or managed entry agreements for innovative medicines, that imply conditional reimbursement and flexible pricing, require a solid evidence basis; highlights the difficulty of collecting both patient- relevant data and healthcare resource utilization data in real healthcare settings; stresses the need for stakeholder involvement and collaborative efforts between Member States and the Commission to step up advancement in the infrastructure necessary to capture outcomes data, through registries and interoperable electronic patient records, e- health and big data analysis, in respect of data privacy;

Amendment 285 #

Motion for a resolution
Paragraph 10 d (new)

10d. Underlines in this context, the need for independent processes of data collection and analysis and for transparency;

Amendment 286 #

Motion for a resolution
Paragraph 10 e (new)

10e. Acknowledges the advantages of using adaptive licensing of new medicines to lower development costs and promote faster patient access; Underlines that a higher degree of uncertainty regarding the safety and effectiveness of a new medicine at the point of entry into the market is inherent to adaptive licensing in comparison with traditional licensing; Recognises the persistence of deficiencies in the current implementation of post- marketing surveillance system; Believes that adaptive licensing should be restricted to specific cases of high unmet medical need and calls the European Commission and the European Medicines Agency to put in place guidelines in order to ensure patient safety; Acknowledges the potential of adaptive pathways for adaptive pricing decision of new medicines, once patient safety is adequately ensured;

Amendment 287 #

Motion for a resolution
Paragraph 11

11. Stresses the importance of assessing the real therapeutic evidence- based added value of new medicines compared to the best available alternative; therefore calls on the Commission to extend the definition of added therapeutic value used for paediatric medicines to all medicines, as follows: "Added therapeutic value could be based on one or more of the following: - reasonable expectation of safety and efficacy for an authorised or new medicinal product to treat a condition, where no authorised medicinal product is on the market; - expected improvement in efficacy, as compared with the current standard of care for the treatment, diagnosis or prevention of the condition concerned; - expected improvement in safety, as regards adverse reactions or potential medication errors as compared with the current standard of care; - improved dosing scheme or method of administration (e.g. number of doses per day, oral compared with intravenous administration, reduced treatment duration) leading to improved safety, efficacy or compliance; - availability of a new clinically relevant formulation or pharmaceutical form; - different mechanism of action, with a scientific explanation of the potential advantage in terms of improved efficacy or safety; - unsatisfactory nature of existing treatments and need for alternative methods expected to involve an - improved benefit-risk balance; and - expected improvement in the quality of life;"

Amendment 288 #

José Inácio FARIA, Jasenko SELIMOVIC, Frédérique RIES, Marian HARKIN, Lieve WIERINCK, Jana TOOM

Motion for a resolution
Paragraph 11 a (new)

11a. Highlights the technical nature of Relative Efficacy and Effectiveness Assessment (REA) and of Therapeutic Added Value (ATV) procedures; Notes that differences in methodological approaches and quality of evidence required at Member State level contribute to unnecessary fragmentation and increased burden for industry;

Amendment 289 #

Motion for a resolution
Paragraph 11 a (new)

11a. Calls on the Commission to clarify the patent period, specially its expiration to analyse the impact of supplementary extensions, data exclusivity or market exclusivity on competitiveness and quality of innovation

Amendment 29 #

Motion for a resolution
Citation 5 l (new)

- having regard the Regulation (EC(816/2006) Compulsory Licensing of Patents Relating to the Manufacturer of Pharmaceutical for Export to Countries with Public Health Problems

Amendment 290 #

José Inácio FARIA, Jasenko SELIMOVIC, Frédérique RIES, Marian HARKIN, Lieve WIERINCK

Motion for a resolution
Paragraph 11 a (new)

11a. Calls for the Commission and the Member States to agree on a common definition for added therapeutic value of medicines and aim at harmonised practices in its assessment;

Amendment 291 #

Motion for a resolution
Paragraph 11 b (new)

11b. Calls on Member States and the Commission to pursue efforts to develop shared capacities, data and methodologies; Calls on the Commission to put forward a proposal for a common framework for REA and ATV to be carried out at European level, with the participation of expert representatives from Member States; Believes this should be done within the existing institutional context and in respect of national competences concerning social and economic considerations within pricing and reimbursement decisions;

Amendment 292 #

Motion for a resolution
Paragraph 11 b (new)

11b. Calls the Commission to promote pharmaceutical and ethical behaviour transparency on the clinical trials and on the real cost of R&D in face to the authorisation and assessment innovation

Amendment 293 #

Motion for a resolution
Paragraph 11 c (new)

11c. Call on the Council to push a rational use of medicines in all Europe, to involve professional in prescribing by active principles and promoting the generic medicines administration

Amendment 294 #

Motion for a resolution
Paragraph 11 d (new)

11d. Call on the Commission to continue monitoring the internal competition in accordance to articles 101 and 102 TFEU and to present a biannual report

Amendment 295 #

Motion for a resolution
Paragraph 11 e (new)

11e. Notes that some countries classify the drugs based on the different levels of innovation in the process of their HTA and are reimbursing in base of that level

Amendment 296 #

Motion for a resolution
Paragraph 12 a (new)

12a. Highlights that current pricing systems such as international reference pricing limits access to innovative medicines in EU countries with comparatively lower GDP per capita; notes with concern that due to the lower negotiating power of small and lower income countries, medicines are comparatively less affordable in such Member States, namely in the oncology area; Regrets, in the context of international reference pricing, the lack of transparency in list prices of medicines as compared to actual prices and the information asymmetry that it brings to negotiations between industry and national health systems;

Amendment 297 #

Motion for a resolution
Paragraph 12 a (new)

12a. Points out that, with a view to developing safe and effective patient- oriented health policies and making health technology as effective as possible, evaluating that technology should be a multidisciplinary process which summarises the medical, social, economic and ethical information on the use of the technology by employing high standards and in a systematic, independent, objective, reproducible and transparent manner.

Amendment 298 #

Motion for a resolution
Paragraph 12 a (new)

12a. Welcomes the Commission’s work on creating more indicators to measure the outcomes of health care operations; Calls for the inclusion of added therapeutic value of a drug as an indicator when deciding on the reimbursement of medicines, as it happens that often drugs and personalised medicines with a higher price tag bring savings for the health care system in the longer term due to their more rapid efficacy;

Amendment 299 #

Motion for a resolution
Paragraph 12 a (new)

12a. Recognises that innovative pricing solutions which align payment to outcomes and which are flexible enough to account for patients' and public payers' purchasing power, burden of illness and/or preferences, can contribute to the sustainability of healthcare systems and should be more widely used to enhance patients access to innovative medicines while addressing affordability constraints;

Amendment 3 #

Motion for a resolution
Citation 1 a (new)

- having regard to article 81 of Directive 2001/83/EC on ensuring appropriate and continued supplies of medicinal products,

Amendment 30 #

Françoise GROSSETÊTE, Frédérique RIES, Elisabetta GARDINI, Cristian-Silviu BUŞOI

Motion for a resolution
Citation 6 a (new)

- having regard to the joint procurement agreement approved by the Commission on 10 April 20141a, __________________ 1a http://ec.europa.eu/health/preparedness_r esponse/docs/jpa_agreement_medicalcou ntermeasures_en.pdf

Amendment 300 #

Motion for a resolution
Paragraph 12 a (new)

12a. Stresses that in the framework of pricing and reimbursement decisions, Member States should not re-assess the elements on which the European marketing authorisation is based, including the quality, safety, efficacy or bioequivalence of the medicinal product leading to delayed access for patients;

Amendment 301 #

Motion for a resolution
Paragraph 12 a (new)

12a. Draws attention to the fact that several obstacles still exist to capture the full potential of incremental innovation notably related to known non-patented molecules, due to the lack of pricing and market access pathways to enable the recognition of the benefits of these medicines;

Amendment 302 #

Karl-Heinz FLORENZ, Peter LIESE

Motion for a resolution
Paragraph 12 b (new)

12b. Highlights that international reference pricing is a driver of delayed market entry for innovative medicines in lower income Member States and of medicines shortages through parallel trade; Invites Member States and the Commission to promote closer cooperation towards a voluntary agreement on a differential pricing system that should reflect factors such as differences in income per capita, and which could enhance overall welfare;

Amendment 303 #

Motion for a resolution
Paragraph 13

~~13. Believes that a fair price should cover the cost of the drug development and production, plus a margin of profit;~~deleted

Amendment 305 #

Nicola CAPUTO, Soledad CABEZÓN RUIZ

Motion for a resolution
Paragraph 13

13. Believes that ~~a fair price should cover the cost of the drug development and production, plus a margin of profit~~prices of medicines should reflect the value they bring to patients, healthcare systems as well as society, further the prices should provide an incentive to invest in new therapies;

Amendment 306 #

Motion for a resolution
Paragraph 13

13. Believes that a fair price should ~~cover the cost of the drug development and production, plus a margin of profit~~be in line with the value they bring to patients, societies and systems, as well as act as a driver to ensure patient access, reward for innovation and sustainable healthcare;

Amendment 307 #

Motion for a resolution
Paragraph 13

13. Believes that a fair price should cover complex factors, such as the cost of the drug development and production, ~~plus a margin of profit~~the risk inherent in pharmaceutical research, the added value that the treatment represents and the results for patients;

Amendment 308 #

Motion for a resolution
Paragraph 13

13. Believes that ~~a fair price should cover the cost of the drug development and production, plus a margin of profit;~~ the failure of the market to systematically invest in needed innovation demonstrates the inefficacy of policies linking the price to the costs of R&D and that a fair price should cover the cost of the drug production, plus a reasonable margin of profit; therefore calls on to the Commission and Member States to explore the implementation of delinkage mechanisms, characterized by the uncoupling of R&D costs and the end prices of health products, to finance research and development as mentioned in the report of the United Nations Secretary General's high level Panel on access to medicines - Promoting innovation and access to health technologies;

Amendment 309 #

Motion for a resolution
Paragraph 13

13. 13. Believes that a fair price ~~should cover~~for a medicine delivering additional benefit to patients should take into account the cost of the drug development and production~~, plus a margin of profit~~;

Amendment 31 #

José Inácio FARIA, Marian HARKIN, Jana TOOM

Motion for a resolution
Citation 6 a (new)

- having regard to the Nairobi Conference of 1985 on the rational use of drugs,

Amendment 310 #

Motion for a resolution
Paragraph 13

13. Believes that a fair price ~~should cover~~for a medicine delivering additional benefit to patients should take into account the cost of the drug development and production~~, plus a margin of profit~~;

Amendment 311 #

Motion for a resolution
Paragraph 13

13. Believes that a fair price should cover the cost of the drug development and production, plus a margin of profit taking into account the public financing received in the first steps of the product development, if applicable;

Amendment 312 #

Motion for a resolution
Paragraph 13

13. Believes that a fair price for a medicine delivering additional benefits to patients should cover the cost of the drug development and production, plus a margin of profit;

Amendment 313 #

Andrey KOVATCHEV, Cristian-Silviu BUŞOI, Kateřina KONEČNÁ, Biljana BORZAN, Karin KADENBACH

Motion for a resolution
Paragraph 13

13. Believes that a fair price should cover the cost of the drug development and production, plus a margin of profit, taking also into account the dedicated population, its efficiency and the level of innovation;

Amendment 314 #

Motion for a resolution
Paragraph 13

13. Believes that ~~a fair price should cover the cost of the drug development and production, plus a margin of profit~~prices of medicines should be adequate to the specific economic situation of the country where they are marketed;

Amendment 315 #

Motion for a resolution
Paragraph 13

13. Believes that a fair price should cover the cost of the drug development and production, plus a fair margin of profit;

Amendment 316 #

Motion for a resolution
Paragraph 13

13. Believes that ~~a fair price should cover the cost of the drug development~~the price of a medicine should provide an incentive for manufacturers to invest in developing new therapies and impro~~duction, plus a margin of profit~~ving existing ones, while ensuring best outcomes for patients, healthcare professionals and payers;

Amendment 317 #

Motion for a resolution
Paragraph 13 a (new)

13a. Stresses the importance of transparency across the field (including as regards clinical data, R&D costs and public funding, marketing strategies, actual prices and reimbursement levels) to improve access to medicines with additional patient and health system relevant benefits;

Amendment 318 #

Motion for a resolution
Paragraph 13 a (new)

13a. Underlines the importance of transparency across the field (including as regards clinical data, research and development costs and public funding, marketing strategies, pricing and reimbursement) to improve access to medicines with additional patient and health system relevant benefits;

Amendment 319 #

Elisabetta GARDINI, Cristian-Silviu BUŞOI, Alojz PETERLE, Giovanni LA VIA, Aldo PATRICIELLO, Alessandra MUSSOLINI

Motion for a resolution
Paragraph 13 a (new)

13a. Calls on the Commission to set up, in cooperation with Member States, a public and regularly updated database with the different prices across the EU of patented and generic medicines and biosimilars, also indicating the geographical distribution of purchase and sales volumes thereof;

Amendment 32 #

Motion for a resolution
Citation 7 a (new)

- having regard to the report approved by the Committee on the Environment, Public Health and Food Safety and by the European Parliament on the amendment of the Regulation 726/2004;

Amendment 320 #

José Inácio FARIA, Jasenko SELIMOVIC, Anneli JÄÄTTEENMÄKI, Marian HARKIN, Jana TOOM

Motion for a resolution
Paragraph 13 a (new)

Amendment 321 #

Motion for a resolution
Paragraph 13 a (new)

13a. Stresses the importance of transparency, including as regards clinical data, R&D costs and public funding, marketing strategies, actual prices and reimbursement levels, to improve access to medicines with relevant additional benefits for patient and health systems;

Amendment 322 #

Motion for a resolution
Paragraph 13 a (new)

13a. Points out that even when a new medicine is of high added value, prices should not be so high that they prevent sustainable access to them in the EU; .

Amendment 323 #

José Inácio FARIA, Anneli JÄÄTTEENMÄKI, Frédérique RIES, Marian HARKIN, Lieve WIERINCK, Jana TOOM

Motion for a resolution
Paragraph 13 a (new)

13a. points out that patient access to innovative therapies within the European Union would be better supported through a differential pricing policy, which could take into account the varying levels of affordability, disease prevalence and healthcare priorities between EU Member States; calls on the Council and the Commission to build on the reflection started by the Belgian Presidency of the EU in 2010, with a view to identifying practical ways to implement differential pricing within the existing legal framework of the TFEU.

Amendment 324 #

Motion for a resolution
Paragraph 13 b (new)

13b. Encourages Members States to engage in early dialogue and horizon scanning with industry, patients and payers and to anticipatorily incorporate in their determination of the cost- effectiveness of new medicines the forecasted evolution in the pharmaceutical innovation pipeline while giving due regard to budgetary impact considerations;

Amendment 325 #

Motion for a resolution
Paragraph 13 b (new)

13b. Points out that patients are the weakest link in access to medicines and difficulties with accessing medicines should not have negative repercussions for them;

Amendment 326 #

Motion for a resolution
Paragraph 13 b (new)

13b. Calls on the Commission to enhance detailed control of use of R&D public funding for medicines, and to make sure that research funds are not invested in marketing;

Amendment 327 #

Motion for a resolution
Paragraph 13 b (new)

13b. stresses that the wide use of International Reference Pricing by EU Member States and parallel trade acts as a deterrent to differential pricing and may have a detrimental effect on patient access in low- and middle-income EU countries; calls on the Commission and Member States to explore alternatives to International Reference Pricing or, as a minimum, a more rational use of this mechanism based on reference baskets representing clusters of countries with a similar socio-economic profile.

Amendment 328 #

Motion for a resolution
Paragraph 13 c (new)

13c. highlights that International Reference Pricing is one of the main obstacles to the increased transparency of pharmaceutical prices; points out that confidential contractual agreements with pharmaceutical companies have proven to be a useful tool to address affordability concerns and to improve patient access to innovative therapies, mitigating the undesired effects of International Reference Pricing to some extent.

Amendment 329 #

Motion for a resolution
Paragraph 13 c (new)

13c. Points out that Directive 89/105/EEC has not been revised in 20 years, and in the meantime important changes have taken place in the medicine system in Europe;

Amendment 33 #

Motion for a resolution
Citation 7 a (new)

- having regard to the obligations contained in Article 81 of European Directive 2001/83/EC, for the maintenance of an appropriate and continued supply of medicinal products;

Amendment 330 #

Motion for a resolution
Paragraph 13 d (new)

13d. Points out that competition among generic drugs is important when it comes to controlling public budgets and those drugs should be placed on the market without unnecessary or unjustified delays;

Amendment 331 #

Françoise GROSSETÊTE, Frédérique RIES, Elisabetta GARDINI, Cristian-Silviu BUŞOI

Motion for a resolution
Paragraph 14

14. Welcomes initiatives such as the Innovative Medicines Initiative (IMI), ~~but regrets that only a few of them are entirely public~~which aim to develop new medicines that address the unmet medical needs of patients, e.g. new antimicrobial agents;

Amendment 332 #

Motion for a resolution
Paragraph 14

14. Welcomes initiatives such as the Innovative Medicines Initiative (IMI), ~~but regrets that only a few of them are entirely public;~~ which bring together the private and public sectors in order to stimulate research and accelerate patients' access to innovative therapies;

Amendment 333 #

Lieve WIERINCK, Gesine MEISSNER, Ulrike MÜLLER

Motion for a resolution
Paragraph 14

14. Welcomes initiatives such as the Innovative Medicines Initiative (IMI)~~, but regrets that only a few of them are entirely public~~;

Amendment 334 #

Motion for a resolution
Paragraph 14

14. Welcomes initiatives such as the Innovative Medicines Initiative (IMI), but regrets th~~at only a few of~~e low level of public return on public investment in them a~~re entirely public~~bsence of access conditionalities to EU public funding;

Amendment 335 #

Motion for a resolution
Paragraph 14

14. Welcomes initiatives such as the Innovative Medicines Initiative (IMI), but ~~regrets~~deplores the fact that only a few of them are entirely public;

Amendment 336 #

Motion for a resolution
Paragraph 14

14. ~~Welcom~~Notes initiatives such as the Innovative Medicines Initiative (IMI), but regrets that only a few of them are entirely public;

Amendment 337 #

Motion for a resolution
Paragraph 14

14. Welcomes initiatives such as the Innovative Medicines Initiative (IMI), but regrets that only a few of them are entirely public; Recognises that pharmaceutical innovation is driven by both public and private investments in a complementary manner, and private investors carry the high risk of failure in the development stage;

Amendment 338 #

Motion for a resolution
Paragraph 14

14. Welcomes initiatives such as the Innovative Medicines Initiative (IMI), but regrets that only a few of them are entirely public; further notes that IMI2 is largely financed by EU taxpayers, stressing the necessity of enhanced EU leadership in prioritizing public health needs of IMI2 research and the inclusion of broad data sharing and pro-public health IP management policies;

Amendment 339 #

Motion for a resolution
Paragraph 14 – subparagraph 1 (new)

(1) Points out that originator companies are complaining about having to repeat the added value assessment for each Member State and that administrative burden can result in delays in accessing medicines;

Amendment 34 #

Motion for a resolution
Citation 7 a (new)

- having regard to the report approved by the Committee on the Environment, Public Health and Food Safety and by the European Parliament on the amendment of the regulation 726/2004;

Amendment 340 #

Motion for a resolution
Paragraph 14a (new)

14a. Calls on the Commission to give renewed political impetus to the proposal to amend Directive 89/105, with a view to making prices more transparent and thus more affordable; calls on the Commission to increase efforts, in accordance with legislation currently in force, to guarantee public access to suitable information on the safety and effectiveness of medicines;

Amendment 341 #

Motion for a resolution
Paragraph 14 a (new)

14a. Highlights with concern that IMI projects have been perceived as replicating work which individual companies would have had to undertake anyway, thereby subsidising private companies with EU money; calls on the Commission in this regard to ensure that IMI projects deliver real added-value for EU citizens

Amendment 342 #

Motion for a resolution
Paragraph 14 a (new)

14a. Points out that an opaque and fragmented market with different medicine, authorisation and pricing and reimbursement assessments may be contributing to inefficiencies as a whole and to inequality among European citizens;

Amendment 343 #

Motion for a resolution
Paragraph 14 b (new)

14b. Calls on the EU, as a public funder of research, to require that knowledge generated from such research is made freely and widely available through publication and online access;

Amendment 344 #

Motion for a resolution
Paragraph 14 b (new)

14b. Points out the need for Member States to deal with the medicine system in a coordinated manner in order to address similar challenges;

Amendment 345 #

Motion for a resolution
Paragraph 15

15. Recalls that transparency in all EU and national institutions and agencies is crucial, and that experts involved in the authorisation process, pricing and setting the reimbursement rates should have no conflicts of interest;

Amendment 346 #

Andrey KOVATCHEV, Cristian-Silviu BUŞOI, Kateřina KONEČNÁ, Biljana BORZAN, Karin KADENBACH

Motion for a resolution
Paragraph 15

15. Recalls that transparency in all EU and national institutions and agencies is crucial to the well functioning of democracy, and that experts involved in the authorisation process should have no conflicts of interest;

Amendment 347 #

Motion for a resolution
Paragraph 16

16. Highlights the European procedure for joint procurement of medicines used for the acquisition of vaccines in accordance with Decision No 1082/2013/EU; encourages the possible use of the procedure in case of shortages of infant vaccines;

Amendment 348 #

José Inácio FARIA, Jasenko SELIMOVIC

Motion for a resolution
Paragraph 16

16. Highlights the European procedure for joint procurement of medicines used for the acquisition of vaccines in accordance with Decision No 1082/2013/EU; encourages Members States to make full use of this tool;

Amendment 349 #

Alberto CIRIO

Motion for a resolution
Paragraph 16

16. Highlights the possibility for a voluntary European procedure for joint procurement of medic~~ines used for the acquisition of vaccine~~al countermeasures for serious cross border health threats in accordance with Decision No 1082/2013/EU;

Amendment 35 #

Motion for a resolution
Citation 7 a (new)

- having regard to European Parliament resolution of 16 September 2015 on the Commission Work Programme 2016 (2015/2729(RSP))

Amendment 350 #

Lieve WIERINCK, Gesine MEISSNER, Frédérique RIES, Marian HARKIN, Jana TOOM, Jasenko SELIMOVIC

Motion for a resolution
Paragraph 16

16. Highlights the European procedure for joint procurement of medic~~ines used for the acquisition of vaccine~~al countermeasures for serious cross border health threats in accordance with Decision No 1082/2013/EU;

Amendment 351 #

Motion for a resolution
Paragraph 16 a (new)

16a. recalls the importance of the digital health agenda and the need to prioritise the development and the implementation of eHealth and mHealth related solutions to ensure safe, reliable, accessible, modern and sustainable new health care models to patients, care givers, healthcare professionals and payers;

Amendment 352 #

Motion for a resolution
Paragraph 16 a (new)

16a. Highlights the negative impact that Member States' austerity policies and budgetary cuts have had on citizens access to healthcare and access to medicines; condemns the situation which has been fostered in healthcare systems whereby the value of a life is equated to wealth, whereby those who are financially better off can receive faster and better quality treatment than those on lower incomes;

Amendment 353 #

Motion for a resolution
Paragraph 16 a (new)

16a. Calls on the Commission to study the coordination of drug procurement among the Member States that have signed the joint procurement agreement, particularly for diseases such as hepatitis C, Crimean–Congo haemorrhagic fever and enteroviruses;

Amendment 354 #

Motion for a resolution
Paragraph 16 a (new)

16a. Points out that the entry of generic drugs into the Market may lead to a 25% price reduction in the first year and 40% in the second, and a 20% saving in the first year and 25% in the second, and that there is concern that placing drugs of that type on the market is not as fast as it should be, as it takes seven months on average from the end of the originator’s exclusive licence;

Amendment 355 #

Elisabetta GARDINI, Cristian-Silviu BUŞOI, Alojz PETERLE, Giovanni LA VIA, Alberto CIRIO, Aldo PATRICIELLO, Alessandra MUSSOLINI

Motion for a resolution
Paragraph 16 a (new)

16a. Notes with concern that the EU lags behind the USA in what regards a standardized and transparent reporting mechanism on the causes of medicines shortages; invites the Commission and Member States to propose and put in place such an instrument for evidence- based policy-making;

Amendment 356 #

Motion for a resolution
Paragraph 16 a (new)

16a. Highlights the role of the European Union in monitoring and providing guidance on economic policies within the framework of the European Semester, and welcomes the production of country-specific recommendations in the field of healthcare sustainability;

Amendment 357 #

Motion for a resolution
Paragraph 16 a (new)

16a. Recalls the lack of transparency - among Member States on the reimbursement systems and the delay in the marketing authorisation go against the Directive 89/105/CEE;

Amendment 358 #

Motion for a resolution
Paragraph 16 a (new)

16a. Points out that improved coordination between national HTAs could reduce the time taken for medicines to become available to patients;

Amendment 359 #

Motion for a resolution
Paragraph 16 a (new)

16a. Underlines the need for further cooperation at EU level to improve access to medicines;

Amendment 36 #

Motion for a resolution
Citation 7 a (new)

- having regard to Directive 2001/83/EC and in particular Article 81 thereof;

Amendment 360 #

Motion for a resolution
Paragraph 16 b (new)

16b. Recalls that the Doha Declaration of 30 August 2003 on the TRIPS Agreement and public health ‘clarifies’ that: ‘the Agreement can and should be interpreted and implemented in a manner supportive of WTO members’ right to protect public health for all. The TRIPS Agreement does not and should not prevent members from taking measures to protect public health and, in particular, to promote access to medicines for all’;

Amendment 361 #

Motion for a resolution
Paragraph 16 b (new)

16b. Highlights the role of the European Union in monitoring and providing guidance on economic policies within the framework of the European Semester, and welcomes the adoption of country-specific recommendations in the area of healthcare systems sustainability;

Amendment 362 #

Motion for a resolution
Paragraph 16 b (new)

16b. Condemns the transforming of health as an inherent right for all people, to a market based commodity that is subject to cost and profiteering which creates a social divide by promoting differential treatment based on a patient's ability to pay;

Amendment 363 #

Motion for a resolution
Paragraph 16 b (new)

16b. Notes that the ERIPID project needs more transparency from Members States to include the real prices paid by them;

Amendment 364 #

Herbert DORFMANN

Motion for a resolution
Subheading 6 a (new)

Calls for regulations in the cross-border trade of medicines to ensure that patients living in a Member State other than their usual Member State of residence have access to them;

Amendment 365 #

Motion for a resolution
Paragraph 17

17. Calls for EU-wide measures to guarantee the right of patients to universal, affordable, effective, safe and timely access to essential and innovative therapies, and to guarantee the sustainability of EU public health care systems; stresses that patient access to medical products is a shared responsibility of all actors of the healthcare system, including national authorities, physicians, patient organizations and manufacturers, and that optimal solutions for patient access can better emerge through collaboration between these stakeholders. Stress the important to enhance voluntary cooperation between member states aimed at greater transparency, to safeguard common interests as well as ensuring the sustainability of national health system.

Amendment 366 #

Motion for a resolution
Paragraph 17

17. Ccalls for EU-wide measures to guarantee the right of patients to universal, affordable, effective, safe and timely access to essential and innovative therapies, ~~and~~ to guarantee the sustainability of EU public health care systems and to ensure future investment in pharmaceutical innovation;

Amendment 367 #

Motion for a resolution
Paragraph 17

17. Calls for EU-wide measures to guarantee the right of patients to universal, affordable, effective, safe and timely access to essential and innovative therapies, and to guarantee the sustainability of EU public health care systems, and also for funding by the Union for investment in research and for the improvement of the health systems of its Member States;

Amendment 368 #

Andrey KOVATCHEV, Cristian-Silviu BUŞOI, Kateřina KONEČNÁ

Motion for a resolution
Paragraph 17

17. Calls ~~for EU-wide~~on the Commission to ensure the implementation of measures to guarantee the right of patients to universal, affordable, effective, safe and timely access to essential and innovative therapies, and to guarantee the sustainability of EU public health care systems;

Amendment 369 #

Motion for a resolution
Paragraph 17

17. Calls for EU-wide measures to guarantee the right of patients to universal, affordable, effective, safe and timely access to essential and innovative therapies, ~~and~~ to guarantee the sustainability of EU public health care systems, and to ensure future investment in pharmaceutical innovation;

Amendment 37 #

Motion for a resolution
Citation 7 b (new)

- having regard to European Parliament resolution of 11 September 2012 on voluntary and unpaid donation of tissues and cells (2011/2193(INI))

Amendment 370 #

Motion for a resolution
Paragraph 17

17. Calls for national and, if necessary, EU-wide measures to guarantee the right of patients to universal, affordable, effective, safe and timely access to essential and innovative therapies, and to guarantee the sustainability of EU public health care systems;

Amendment 371 #

Mireille D'ORNANO, Jean-François JALKH, Sylvie GODDYN

Motion for a resolution
Paragraph 17

Amendment 372 #

Motion for a resolution
Paragraph 17

Amendment 373 #

Aldo PATRICIELLO

Motion for a resolution
Paragraph 17

17. Calls for EU-wide measures to guarantee the right of patients to universal, affordable, equal, effective, safe and timely access to essential and innovative therapies, and to guarantee the sustainability of EU public health care systems;

Amendment 374 #

Motion for a resolution
Paragraph 17

17. Calls for ~~EU-wid~~Member States to take measures to guarantee the right of patients to universal, affordable, effective, safe and timely access to essential and innovative therapies, and to guarantee the sustainability of EU public health care systems;

Amendment 375 #

Motion for a resolution
Paragraph 17

17. Calls for ~~EU-wide~~ measures to guarantee the right of patients to universal, affordable, effective, safe and timely access to essential and innovative therapies, and to guarantee the sustainability of EU public health care systems;

Amendment 376 #

Mireille D'ORNANO, Jean-François JALKH, Sylvie GODDYN

Motion for a resolution
Paragraph 17a (new)

17a. Calls on the Commission to launch a public consultation open to all stakeholders aimed at considering the creation of a European Public Pharmaceutical Company, with the main minimum objective of remedying the absence of the private sector of the pharmaceuticals industry when it comes to conditions for which the market does not offer a sufficient economic return;

Amendment 377 #

Motion for a resolution
Paragraph 17 a (new)

17a. Stresses that as a result of austerity and its consequences on health systems (including frequent pharmaceutical product reimbursement reversals), Europeans are increasingly often obliged to give up medical care and/or pharmaceutical treatments which they need;

Amendment 378 #

Motion for a resolution
Paragraph 17 a (new)

17a. Encourages Member States to evaluate healthcare pathways and policies with a view to improving patient outcomes and the financial sustainability of the system notably by fostering digital solutions to improve healthcare delivery to patients and identify waste of resources;

Amendment 379 #

Motion for a resolution
Paragraph 17 a (new)

17a. Highlights the role of the European Union in monitoring and providing guidance on economic policies within the framework of the European Semester and welcomes the production of country-specific recommendations in the field of healthcare sustainability;

Amendment 38 #

Motion for a resolution
Recital Α

A. whereas the Charter of Fundamental Rights of the European Union recognises the fundamental right of citizens to health and medical treatment2, which every EU Member State must protect; __________________ 2 The right to health care is the economic, social and cultural right to a universal minimum standard of health care to which all individuals are entitled.

Amendment 380 #

Motion for a resolution
Paragraph 14b (new)

17b. Calls on the Commission and the Member States to take the first step towards creating a European Public Pharmaceutical Company, by creating a central European facility from which to buy medicines, starting with life-saving medicines, price differences for which cannot be tolerated within the EU;

Amendment 381 #

Motion for a resolution
Paragraph 18

18. Calls ~~for EU-wide measures on the pharmaceutical market~~on the Member States, in cooperation with the Commission, to join forces to reinforce the negotiation capacities of Member States in order to achieve availability and fair prices ofor medicines all across the EU;

Amendment 382 #

Elisabetta GARDINI, Cristian-Silviu BUŞOI, Alojz PETERLE, Giovanni LA VIA, Aldo PATRICIELLO, Alessandra MUSSOLINI

Motion for a resolution
Paragraph 18

18. Calls for ~~EU-wide~~ measures ~~on the pharmaceutical market to reinforce th~~to facilitate negotiation capacities of Member States in order to ~~achieve fair pri~~ensure patient access ~~for~~to medicines;

Amendment 383 #

Motion for a resolution
Paragraph 18

18. Calls for EU-wide measures on the pharmaceutical market to reinforce the negotiation capacities of Member States in order to ~~achieve fair prices for~~ensure fast and equitable access to innovative medicines;

Amendment 384 #

Mireille D'ORNANO, Jean-François JALKH, Sylvie GODDYN

Motion for a resolution
Paragraph 18

Amendment 385 #

Motion for a resolution
Paragraph 18

18. Calls for ~~EU-wide~~every Member State to adopt measures on the pharmaceutical market to; stresses that they must reinforce the negotiation capacities of Member States in order to achieve fair prices for medicines;

Amendment 386 #

Motion for a resolution
Paragraph 18

18. Calls for EU-wide measures on the pharmaceutical market to reinforce the negotiation capacities of Member States in order to achieve fair prices for medicines;, health systems sustainability; to reach fair prices of medicines and to promote sustainable and qualitative innovation and research as well as the competitiveness on industry

Amendment 387 #

Motion for a resolution
Paragraph 18

18. Calls for EU-wide measures on the pharmaceutical market to reinforce the negotiation capacities of Member States in order to achieve fair prices for medicines, including by strengthening collaborations in health technology assessment (HTA) and evaluating its relative effectiveness at EU level;

Amendment 388 #

Lieve WIERINCK, Frédérique RIES, José Inácio FARIA, Marian HARKIN

Motion for a resolution
Paragraph 18

18. Calls for EU-wide and regional measures on the pharmaceutical market to reinforce the negotiation capacities of Member States in order to achieve fair prices for medicines;

Amendment 389 #

Motion for a resolution
Paragraph 18

18. Calls for EU-wide measures on the pharmaceutical market to reinforce the negotiation capacities of Member States in order to achieve fair prices for medicines, such as the initiative of the Benelux countries and Austria on rare diseases;

Amendment 39 #

Motion for a resolution
Recital A a (new)

Aa. whereas patients require and are entitled to maximum transparency when it comes to setting the price of medicines, the cost of investments in research and development, and the results of studies funded by public research or private research incentivised by public funds;

Amendment 390 #

Motion for a resolution
Paragraph 18 a (new)

18 a. Welcomes the Report of the United Nations Secretary-General's High-Level Panel on Access to Medicines and calls on the Commission and on Member States to take steps to implement the recommendations made therein;

Amendment 391 #

Alberto CIRIO

Motion for a resolution
Paragraph 19

Amendment 392 #

Elisabetta GARDINI, Cristian-Silviu BUŞOI, Alojz PETERLE, Françoise GROSSETÊTE, Giovanni LA VIA, Aldo PATRICIELLO, Alessandra MUSSOLINI

Motion for a resolution
Paragraph 19

19. Calls on the Commission to promote transparency on the costs of R&D and to promote R&D driven by patients’' needs, while fostering social responsibility in the pharmaceutical sector, by setting up an EU public platform ~~for R&D funded by contributions from profits made by the pharmaceutical industry through sales to public health systems; calls for transparency on the costs of R&D~~aiming at defining EU public health needs in a democratic and inclusive way based on: - analysis of the sales volumes for each medicine and for each therapeutic indication, to the extent possible including off-label use - analysis of the burden of each disease, taking social and geographical distribution into account - analysis of national registries for diseases and syndromes - consultations with the Council, the Parliament, EMA and ECDC - consultations with all stakeholders in a public and transparent way, including first and foremost patients, carers and doctors, including those who work with alternative treatments to chemical ones;

Amendment 393 #

Motion for a resolution
Paragraph 19

19. Calls on the Commission to promote R&D driven by patients’ needs, while fostering social responsibility in the pharmaceutical sector, by setting up an EU public platform for R&D funded by contributions from profits made by the pharmaceutical industry through sales to public health systems; calls for transparency on the costs of R&Dinvolve patients and their organisations in the definition of research priorities of all its programmes related to health, to promote R&D driven by patients' need;

Amendment 394 #

Motion for a resolution
Paragraph 19

19. Calls on the Commission to promote R&D driven by patients’ needs, while fostering social responsibility in the pharmaceutical sector, by setting up an EU public platform for R&D funded by contributions from profits made by the pharmaceutical industry through sales to public health systems; calls for transparency on the costs of R&Dinvolve patients and their organizations in the definition of research priorities of all its programs related to health, to promote R&D driven by patients' need;

Amendment 395 #

Motion for a resolution
Paragraph 19

19. Calls on the Commission to promote R&D driven by patients’ needs, ~~while fostering social responsibility in the pharmaceutical sector, by setting up an EU public platform for R&D funded by contributions from profits made by the~~by setting up an EU public fund to finance R&D oriented towards unmet medical needs, in phar~~maceutical industry through sales to public health system~~ticular in the field of rare diseases and paediatric diseases; calls for more transparency onregarding the costs of R&D;

Amendment 396 #

Motion for a resolution
Paragraph 19

19. Calls on the Commission ~~to promo~~and the Member States to foster R&D driven by patients’ unmet needs, while fostering social responsibility in the pharmaceutical sector, by setting up an EU public platform for R&D funded by contributions from profits made by the pharmaceutical industry through sales to public health systems; calls for transparency on the costs of R&Dsuch as researching new antimicrobes, to coordinate public resources for healthcare research in an effective manner and to foster social responsibility in the pharmaceutical sector by creating a European research platform;

Amendment 397 #

Motion for a resolution
Paragraph 19

19. Calls on the Commission to promote R&D driven by national health requirements and patients’ needs, while fostering social responsibility in the pharmaceutical sector, by setting up an EU public platform for R&D funded by contributions from profits ~~made~~earned by the pharmaceutical industry through sales to public health systems ~~only~~; calls for maximum transparency on the costs of R&D, taking the legitimate scientific, public and private interests of the relevant stakeholders into account;

Amendment 398 #

Tibor SZANYI

Motion for a resolution
Paragraph 19

19. Calls on the Commission to promote R&D driven by public health and patients’ needs, while fostering social responsibility in the pharmaceutical sector, by setting up an EU public platform for R&D funded by contributions from profits made by the pharmaceutical industry through sales to public health systems; calls for transparency on the costs of R&D;

Amendment 399 #

Motion for a resolution
Paragraph 19

Amendment 4 #

Motion for a resolution
Citation 1 b (new)

- having regard to the Commission’s Inception Impact Assessment1a on the strengthening of EU cooperation on Health Technology Assessment (HTA), __________________ 1ahttp://ec.europa.eu/smart- regulation/roadmaps/docs/2016_sante_14 4_health_technology_assessments_en.pdf

Amendment 400 #

Motion for a resolution
Paragraph 19

Amendment 401 #

Kateřina KONEČNÁ, Biljana BORZAN

Motion for a resolution
Paragraph 19

19. Calls on the Commission to promote R&D driven by p~~atients’~~ublic health needs, while fostering social responsibility in the pharmaceutical sector, by setting up an EU public platform for R&D funded by contributions from profits made by the pharmaceutical industry through sales to public health systems; calls for transparency on the costs of R&D;

Amendment 402 #

Motion for a resolution
Paragraph 19 a (new)

19a. Calls on the European Commission to promote EMA's initiative on the safe use of adaptive pathways where it is deemed appropriate, to reduce the time to bring to the market medicines that address unmet medical needs and to ensure that marketing authorization will be granted without compromising patient safety, and only if there is a positive balance of benefits and risks for a defined patient population;

Amendment 403 #

Elena GENTILE, Massimo PAOLUCCI

Motion for a resolution
Paragraph 19 a (new)

19a. Highlights the threat of growing antimicrobial resistance; calls on the Commission to put forward measures to promote R&D in the public and the private sector and to build a business case to incentivise the development and commercialisation of antibiotics of last resource to fight the lack of innovation in this area;

Amendment 404 #

Motion for a resolution
Paragraph 19a (new)

19a. Calls on the Commission to promote initiatives for guiding public and private-sector research towards bringing out innovative medicines for curing childhood illnesses;

Amendment 405 #

Elena GENTILE, Massimo PAOLUCCI

Motion for a resolution
Paragraph 19b (new)

19b. Calls on the Commission to promote public and private-sector research into medicines for female patients, to remedy gender inequality in research and development and allow all citizens to benefit from fairer access to medicines;

Amendment 406 #

Motion for a resolution
Paragraph 20

20. ~~Calls on the Commission to~~Notes the Council Conclusions of 17 June 2016 inviting the Commission to conduct a fact- and evidence-based analyseis on the overall impact of IP in promoting innovation, especially the impact of supplementary protection certificates (SPCs), data exclusivity or market exclusivity on competitiveness and quality of innovation, and ~~to set strict limits on~~where necessary, to regulate these practices;

Amendment 407 #

Motion for a resolution
Paragraph 20

20. Calls on the Commission to analyse the overall impact of IP in promoting innovation, as also requested by the Council in its Council Conclusions on 17 June 2016, especially the impact of supplementary protection certificates (SPCs), data exclusivity or market exclusivity on competitiveness and quality of innovation, and to set strict limits on these practices;

Amendment 408 #

Motion for a resolution
Paragraph 20

20. Calls on the Commission to analyse the overall impact of IP in promoting ~~innovation,~~needs-driven innovation, affordability and commensurably improved therapeutic outcomes especially the impact of supplementary protection certificates (SPCs), data exclusivity orand market exclusivity on competitiveness and quality of innovation, and to ~~set strict limits on these practices~~amend legislation accordingly;

Amendment 409 #

Mireille D'ORNANO, Jean-François JALKH, Sylvie GODDYN

Motion for a resolution
Paragraph 20

20. Calls on the Commission to analyse through a deep, objective and unbiased study the overall impact of IP in promoting innovation and on patient access, especially the impact of supplementary protection certificates (SPCs), data exclusivity or market exclusivity on competitiveness and quality of innovation, and to set strict limits on these practices;

Amendment 41 #

Motion for a resolution
Recital A a (new)

Aa. whereas Article 168 of the Treaty on the Functioning of the European Union stipulates that decisions on their health systems fall within the competence of the Member States;

Amendment 410 #

Motion for a resolution
Paragraph 20

20. Calls on the Commission to analyse the overall impact of IP in promoting innovation and patients’ access to drugs, especially the impact of supplementary protection certificates (SPCs), data exclusivity or market exclusivity on competitiveness and quality of innovation, and to set strict limits on these practices;

Amendment 411 #

Motion for a resolution
Paragraph 20

20. Calls on the Commission to analyse the overall impact of IP in promoting innovation, with regard, in particular, to the quality of innovations, especially the impact of supplementary protection certificates (SPCs), data exclusivity or market exclusivity on competitiveness and quality of innovation, a~~nd to set strict limits on these practic~~long with the impact on access to the medicines;

Amendment 412 #

Motion for a resolution
Paragraph 20

20. Calls on the Commission to analyse ~~the overall impact of IP in~~how to best promot~~ing~~e innovation, especially the impact of supplementary protection certificates (SPCs), data exclusivity or market exclusivity on competitiveness and quality of innovation~~, and to set strict limits on these practices~~;

Amendment 413 #

Motion for a resolution
Paragraph 20

20. Calls on the Commission to analyse the overall impact of IP in promoting innovation and on patient access, especially the impact of supplementary protection certificates (SPCs), data exclusivity or market exclusivity on competitiveness and quality of innovation, and to set strict limits on these practices;

Amendment 414 #

Motion for a resolution
Paragraph 20

20. Calls on the Commission to analyse the overall impact of IP in promoting innovation and patient access, especially the impact of supplementary protection certificates (SPCs), data exclusivity or market exclusivity on competitiveness and quality of innovation, and to set strict limits on these practices;

Amendment 415 #

Motion for a resolution
Paragraph 20

20. Calls on the Commission to analyse the overall impact of IP in ~~promoting~~delaying access to innovation, especially the impact of supplementary protection certificates (SPCs), data exclusivity or market exclusivity on competitiveness and quality of innovation, and to set strict limits on these practices;

Amendment 416 #

Nicola CAPUTO, Marc TARABELLA, Soledad CABEZÓN RUIZ

Motion for a resolution
Paragraph 20

20. Calls on the Commission to analyse the overall impact of IP in promoting innovation with a neutral, fact-based and comprehensive approach, especially the impact of supplementary protection certificates (SPCs), data exclusivity or market exclusivity on competitiveness and quality of innovation~~, and to set strict limits on these practices~~;

Amendment 417 #

Motion for a resolution
Paragraph 20 a (new)

20a. Invites the Commission to prepare, as soon as possible and with the close involvement of the Member States, an overview of the current EU legislative instruments and related incentives that aim to facilitate the investment in the development of medicinal products and the marketing authorization of medicinal products given to the holders of a marketing authorisation as implemented within the EU: Supplementary Protection Certificates (Regulation EC 469/2009), medicinal products for human use (Directive 2001/83/EC and Regulation EC 726/2004), orphan medicinal products (Regulation EC 141/2000) and paediatrics (Regulation EC 1901/2006); invites also the Commission to prepare an evidence based analysis of the impact of the incentives in these EU legislative instruments, as implemented, on innovation, as well as on the availability, in particular supply shortages and deferred or missed market launches, and accessibility of medicinal products, including high priced essential medicinal products for conditions that pose a high burden for patients and health systems as well as availability of generic medicinal products; calls on the Commission to prepare in the coming months a timetable and methodology for conducting the analysis as mentioned in this paragraph;

Amendment 418 #

Andrey KOVATCHEV, Cristian-Silviu BUŞOI, Kateřina KONEČNÁ, Biljana BORZAN, Karl-Heinz FLORENZ, Karin KADENBACH

Motion for a resolution
Paragraph 20 a (new)

20a. Recalls that maintaining incentives is important to attract R&D in Europe and deliver quality innovative treatments to patients, therefore encourages the Commission not to revise incentive frameworks that have proven successful in delivering the intended results, such as the Regulation on orphan medicinal products, and calls on the Commission to perform, when the case, evidence-based analysis of the impact of incentives provided by the EU legislative framework based on an objective, balanced and scientifically sound methodology;

Amendment 419 #

Motion for a resolution
Paragraph 20 a (new)

20a. Calls on the Commission to adopt a targeted SPC manufacturing waiver for export purposes to allow EU-based manufacturers of generic and biosimilar medicines to compete on equal footing with competitors from non-EU countries, thus avoiding the outsourcing of production and helping to maintain and create additional jobs and growth in the EU;

Amendment 42 #

José Inácio FARIA, Frédérique RIES, Marian HARKIN, Jana TOOM

Motion for a resolution
Recital B

B. whereas public health systems are crucial to guarantee universal access to health care; believes this to be a fundamental right of European citizens; further believes this to be the only way to ensure equality in healthcare for citizens in all European Union Member States.

Amendment 420 #

Motion for a resolution
Paragraph 20 a (new)

20a. Acknowledges that the incentives put forward by the Paediatric Regulation have not proved effective to drive innovation in medicines for children, namely in the fields of oncology and neonatology; calls on the Commission to examine existing obstacles and propose measures to promote advancement in this area;

Amendment 421 #

Elisabetta GARDINI, Alojz PETERLE, Giovanni LA VIA, Aldo PATRICIELLO, Alessandra MUSSOLINI

Motion for a resolution
Paragraph 20 a (new)

20a. Calls on EU Member States and the pharmaceutical industry to increase transparency on the process of pricing and reimbursement of pharmaceutical products, including the costs of R&D;

Amendment 422 #

Motion for a resolution
Paragraph 20 a (new)

20a. Calls on the EU Member states and the pharmaceutical industry to increase transparency on the process of pricing and reimbursement of pharmaceutical products, including the costs of R&D;

Amendment 423 #

Motion for a resolution
Paragraph 20 b (new)

20b. Recognises that off-label use of medicines can bring benefits to patients when approved alternatives are absent; Notes with concern that patients are subject to increased risks due to the lack of a solid evidence-base proving safety and efficacy of off-label use, to the lack of informed consent and to increased difficulty in monitoring adverse events; underlines that certain population sub- groups are particularly exposed to this practice such as children and the elderly;

Amendment 424 #

Motion for a resolution
Paragraph 20 c (new)

20c. Calls on the Commission, the European Medicines Agency and Member States to promote Good Off-Label Use Guidelines in order to reduce patients' risk associated with this clinical practice; Calls on the Commission to analyse the drivers of off-label use and to propose measures that mitigate the need for this clinical practice, by promoting access to all patients' groups to licensed indications, for example through adequate incentives for drug repurposing and new indication licensing;

Amendment 425 #

José Inácio FARIA, Marian HARKIN

Motion for a resolution
Paragraph 20 d (new)

20d. Calls on the Commission to collaborate with the European Medicines Agency and with stakeholders with a view to introduce a Code of Practice for mandatory reporting of adverse events and of outcomes for off-label use of medicines and to ensure patients' registries in order to strengthen the evidence base and mitigate risks for patients;

Amendment 426 #

Motion for a resolution
Paragraph 20 e (new)

20e. Acknowledges the significant development of medicinal products with the orphan designation following the incentives put in place by the current legislative framework on orphan medicinal products; notes that such medicines are also used off-label, or repurposed and authorised for additional indications allowing increased sales and returns; calls on the Commission to examine these occurrences and to monitor the volume of sales of such medicines to ensure balanced incentives without discouraging innovation in this area;

Amendment 427 #

Motion for a resolution
Paragraph 20 f (new)

20f. Notes that the repurposing of existing drugs for new indications can be accompanied by a price increase; asks the Commission to collect and analyse data on price increases in cases of drug repurposing and to report back to the European Parliament and the Council on the balance and proportionality of the incentives that encourage industry to invest in drug repurposing;

Amendment 428 #

Motion for a resolution
Paragraph 20 g (new)

20g. Recognises the need to ensure the continued supply of medicines with proven added value for patients and health systems; Calls on the Commission to monitor and to propose measures, when appropriate, on the withdrawal of old molecules from the market for commercial reasons, including its re- authorisation for a new indication at a much higher price;

Amendment 429 #

Motion for a resolution
Paragraph 21

21. Calls on the Commission to promote open data in private research, especially where public funding is involved, and to establish conditions such as affordable pricing and non-exclusivity, or co-ownership of IP for projects funded by EU public grants such as Horizon 2020where public funding is involved;

Amendment 43 #

Motion for a resolution
Recital B a (new)

Ba. whereas, also following the economic crisis and austerity policies, the public coffers in Europe, and particularly in sectors that cover health spending, are under significant pressure due to sovereign debt and the need to limit spending;

Amendment 430 #

Motion for a resolution
Paragraph 21

21. Calls on the Commission to promote open data in private research, especially where public funding is involved, and to ~~establish conditions~~require conditions to ensure a public health return on investment in biomedical research, such as affordable pricing and non-exclusivity, or co-ownership of IP for projects funded by EU public grants such as Horizon 2020;

Amendment 431 #

Motion for a resolution
Paragraph 21

21. Calls on the Commission to promote ~~open data in private research, especially where~~as far as possible open data where a significant amount of public funding is involved, and to e~~stablish~~ncourage conditions such as affordable pricing and non- exclusivity, or co-ownership of IP for projects funded by EU public grants such as Horizon 2020;

Amendment 432 #

Motion for a resolution
Paragraph 21

21. Calls on the Commission to promote open data in ~~private research, especially where public funding is involved~~research on public health, and to establish conditions such as affordable pricing and non-exclusivity, or co-ownership of IP for projects funded by EU public grants such as Horizon 2020 and IMI;

Amendment 433 #

Motion for a resolution
Paragraph 21

21. Calls on the Commission to promote open data in private research, ~~especially~~ where public funding is involved, and to establish conditions such as affordable pricing and non-exclusivity, or co- ownership of IP for projects funded by EU public grants such as Horizon 2020;

Amendment 434 #

Nicola CAPUTO, Marc TARABELLA, Soledad CABEZÓN RUIZ

Motion for a resolution
Paragraph 21a (new)

21a. Urges the Commission to adopt a strategic plan aimed at preventing the spread of HCV and eradicating the Hepatitis C epidemic through the use of new and old medicines, to be administered to all patients diagnosed with hepatic fibroses caused by Hepatitis C starting from at least stage F2, when damage to the fibrocicatricial tissue can be considered significant, up to stage F3 when sclerocicatricial damage is severe, and stage F4 when the patient is considered cirrhotic or pre-cirrhotic;

Amendment 435 #

Motion for a resolution
Paragraph 21 a (new)

21a. Stresses that both public and private investments are essential for the research and development of innovative medicinal products; notes that in those cases where public investment has played a major role in the development of certain innovative medicinal products, a fair share of the return on investment in such products should preferably be used for further innovative research in the public health interest for example through agreements made on benefit sharing during the research phase;

Amendment 436 #

Motion for a resolution
Paragraph 21 a (new)

21a. Calls for the framework conditions in the areas of research and medicine policy to be established in a way that promotes innovation, particularly against diseases such as cancer, which cannot yet be treated to a satisfactory degree;

Amendment 437 #

Motion for a resolution
Paragraph 21 a (new)

21a. Calls on the Commission, when engaged in bilateral trade and investment partnerships to ensure that these agreements do not include provisions that interfere with the obligations of Member States to fulfil the right to health;

Amendment 438 #

Motion for a resolution
Paragraph 22

~~22.~~ Calls on the Commission to ~~review 22. the regulatory framework for orphan medicin~~streamline the implementation of the current regulatory framework for orphan medicines, and if necessary review it in order to ensure on the one hand the development of medicines for rare diseases and on the other hand the correct application of the current rules and incentives, to define clearly the concept of unmet medical needs, to assess the impact of incentives to develop effective, safe and affordable drugs compared to the best available alternative and to promote the European register of rare diseases and reference centres;

Amendment 439 #

Motion for a resolution
Paragraph 22

22. Calls on the Commission to ~~review~~analyse the implementation of the regulatory framework for orphan medicines~~, to define clearly the concept of unmet medical needs, to assess~~ and subsequently decide whether i~~mpact of incentives to develop effective, safe and affordable drugs compared to the best available alternative~~t needs to be revised, and to promote the European register of rare diseases and reference centres;

Amendment 440 #

Motion for a resolution
Paragraph 22

22. Calls on the Commission to review the regulatory framework for orphan medicines, to define clearly the concept of unmet medical needs, to better determine the level of new development, to assess the impact of incentives to develop effective, safe and affordable drugs compared to the best available alternative ~~and~~, to promote the European register of rare diseases and reference centres and to ensure the correct implementation of the legislation;

Amendment 441 #

Elisabetta GARDINI, Cristian-Silviu BUŞOI, Alojz PETERLE, Giovanni LA VIA, Aldo PATRICIELLO, Alessandra MUSSOLINI

Motion for a resolution
Paragraph 22

22. Calls on the Commission to review the regulatory framework for orphan medicines, to define clearly the concept of unmet medical needs, to assess the impact of incentives to develop effective, safe and affordable drugs compared to the best available alternative and to promote the principle of simultaneous introduction of orphan medicines in all Member States, as well as the European register of rare diseases and reference centres;

Amendment 442 #

Motion for a resolution
Paragraph 22

22. Calls on the Commission to ~~review~~update the regulatory framework for orphan medicines, to ~~define clearly the concept of unmet medical needs, to assess the impact of incentives to develop effective, safe and affordable drugs~~provide guidance on priority unmet medical needs, and to review existing incentives schemes to facilitate the development of effective, safe and affordable drugs for rare diseases, including rare cancers, compared to the best available alternative and to promote the European register of rare diseases and reference centres;

Amendment 443 #

Motion for a resolution
Paragraph 22

22. Calls on the Commission to ~~review~~update the regulatory framework for orphan medicines, to ~~define clearly the concept of unmet medical needs, to assess the impact of incentives to develop effective, safe and affordable drugs~~provide guidance on priority unmet medical needs, and to review existing incentive schemes to facilitate the development of effective, safe and affordable drugs for rare diseases, including rare cancers, compared to the best available alternative and to promote the European register of rare diseases and reference centres;

Amendment 444 #

Lieve WIERINCK, Gesine MEISSNER, José Inácio FARIA, Marian HARKIN, Jasenko SELIMOVIC

Motion for a resolution
Paragraph 22

22. Calls on the Commission to fully and comprehensively review the regulatory framework for orphan medicines, to define clearly the concept of unmet medical needs, to assess the impact of incentives to develop effective, safe and affordable drugs compared to the best available alternative and to promote the European register of rare diseases and reference centres;

Amendment 445 #

Aldo PATRICIELLO

Motion for a resolution
Paragraph 22

22. Calls on the Commission to review the regulatory framework for orphan medicines, to define clearly the concept of unmet medical needs, to assess the impact of incentives to develop effective, safe and affordable drugs compared to the best available alternative and to ~~promote~~redraft, as a priority, the European register of rare diseases and reference centres;

Amendment 446 #

Motion for a resolution
Paragraph 22

22. Calls on the Commission to rev~~iew~~ aluate the regulatory framework for orphan medicines, to define clearly the concept of unmet medical needs, to assess the impact of incentives to develop effective, safe and affordable drugs compared to the best available alternative and to promote the European register of rare diseases and reference centres;

Amendment 447 #

Motion for a resolution
Paragraph 22

22. Calls on the Commission to review the regulatory framework for orphan medicines, to define clearly the concept of unmet medical needs, to assess the impact of incentives to develop effective, safe and affordable drugs comparHighlights the success of Regulation (EC) No 141/2000 on orphan medicinal products, which enabled a number of innovative products for misdiagnosed patients or patients deprived of treatment to be placed ton the ~~best available alternative and~~market; calls on the Commission to promote the European register of rare diseases and reference centres;

Amendment 448 #

Motion for a resolution
Paragraph 22 a (new)

22a. Calls on the Commission and the Member States to establish European registers of rare diseases, national reference centres with experts such as doctors that prescribe drugs and monitoring centres to improve evidence; to place emphasis on transparency in pricing and reimbursement, improving the authorisation procedure on the basis of the best evidence bought and transparency in study and cost data, particularly when public financing exists follow-up monitoring by way of high- quality trials after placing on the market on the basis of safety and optimum benefit for the patient; to push for the revision of the definition of unmet medical needs, the definition of ‘no satisfactory treatment’ and ‘additional benefits to the existing alternatives’, the criterion for measuring the effectiveness of rare disease treatments;

Amendment 449 #

Motion for a resolution
Paragraph 22 a (new)

22a. Calls on the Commission to immediately begin work on the report required under Article 50 of the Paediatric Medicines Regulation and to amend the legislation to address the lack of innovation in paediatric oncology treatments by revising the criteria for allowing a Paediatric Investigation Plan (PIP) waiver and to ensure that PIPs are implemented early in a drug's development so that children are not waiting longer than necessary for access to innovative new treatments;

Amendment 45 #

Andrey KOVATCHEV, Cristian-Silviu BUŞOI, Kateřina KONEČNÁ, Biljana BORZAN

Motion for a resolution
Recital B a (new)

Ba. whereas there are policy incoherencies between public health objectives, trade and intellectual property rules, and international human rights; whereas, nonetheless, State obligations include duties not only to respect, but to protect and fulfil the right to health;

Amendment 450 #

Motion for a resolution
Paragraph 22 a (new)

22a. Calls on the Commission to analyse the adequacy of the legislative framework to the current situation with the parallel export and re-export of medicines, and underlines the need to strike the right balance between public health and economic considerations;

Amendment 451 #

Elisabetta GARDINI

Motion for a resolution
Paragraph 22 a (new)

22a. Calls on the Commission for further actions to foster the development and the patients access to ATMPs, with a particular focus on the lack of harmonisation regarding the conditions required by Member States for the application of the Hospital Exemption;

Amendment 452 #

Motion for a resolution
Paragraph 22 a (new)

22a. Stress the importance to clearly demonstrate the added value in terms of R&I in marketing authorisation of so called orphan drugs.

Amendment 453 #

Motion for a resolution
Paragraph 22 a (new)

22a. Calls on the Commission to clearly define the concept of unmet medical needs;

Amendment 454 #

Motion for a resolution
Paragraph 22 b (new)

22b. Calls on the Commission to revise the clinical and socioeconomic impact of the incentives for researching less prevalent areas such as rare diseases, paediatrics and advanced therapies;

Amendment 455 #

Motion for a resolution
Paragraph 23

23. Calls on the Commission to maintain and set up if necessary strong rules aimed at guaranteeing safety and efficacy in any fast- track approval process and to ~~introduce the concept of conditional authorisation based on effectiveness~~ensure that such approvals are made possible only in exceptional circumstances where a clear unmet medical need has been identified;

Amendment 456 #

Elisabetta GARDINI, Cristian-Silviu BUŞOI, Françoise GROSSETÊTE, Giovanni LA VIA, Aldo PATRICIELLO, Alessandra MUSSOLINI

Motion for a resolution
Paragraph 23

23. Calls on the Commission to ~~guarantee safety and efficacy in any~~promote fast- track approval process ~~and to introduce the concept of c~~es for unmet medical needs and to introduce transparent and accountable processes to mondit~~ional authorisation based on~~or safety and effectiveness;

Amendment 457 #

Motion for a resolution
Paragraph 23

23. Calls on the Commission ~~to guarantee safety and efficacy in any~~promote fast- track approval process ~~and to introduce the concept of conditional authorisation based on~~es for unmet medical needs, and to introduce transparent and accountable process to monitor safety and effectiveness;

Amendment 458 #

Karl-Heinz FLORENZ

Motion for a resolution
Paragraph 23

23. Calls on the Commission to ~~guarantee~~ensure a thorough assessment of quality, safety and efficacy in any fast- track approval process and to introduce the ~~concept of conditional authorisation based on effectiveness~~systematic monitoring of the conditions and sanctions as regards non-compliance;

Amendment 459 #

Mireille D'ORNANO, Jean-François JALKH, Sylvie GODDYN

Motion for a resolution
Paragraph 23

23. Calls on the Commission to guarantee safety and efficacy in any fast- track approval process and to ~~introduce the concept of conditional~~guarantee that the existing schemes of early marketing authoriszation ~~based on effectiveness~~are restricted to a limited range of medicines addressing "unmet medical need" and when there is no other available alternative;

Amendment 46 #

Motion for a resolution
Recital B a (new)

Ba. whereas, however, every Member State has its own national legislation and tax policy, including VAT rates and mechanisms to negotiate pharmaceutical product prices;

Amendment 460 #

José Inácio FARIA, Jasenko SELIMOVIC, Frédérique RIES, Marian HARKIN, Lieve WIERINCK, Jana TOOM

Motion for a resolution
Paragraph 23

23. Calls on the Commission to guarantee safety and efficacy in any fast- track approval process and to ~~introduce the concept of conditional authorisation based on effectiveness~~ensure that such approvals are admissible in exceptional circumstances where a high unmet medical need has been identified;

Amendment 461 #

Motion for a resolution
Paragraph 23

23. Calls on the Commission to only allow fast-track approval in exceptional and duly justified urgencies, to guarantee safety and efficacy in any ~~fast- track approval~~ process and to introduce the concept of conditional authorisation based on effectiveness;

Amendment 462 #

Motion for a resolution
Paragraph 23

23. Calls on the Commission to guarantee safety and efficacy in any fast- track approval process and to introduce the concept of conditional authorisation based on ~~effectivenes~~clinical trial data that demonstrate an advance over existing treatment options for patients and clinically-relevant outcomes;

Amendment 463 #

György HÖLVÉNYI, Alojz PETERLE, Miroslav MIKOLÁŠIK

Motion for a resolution
Paragraph 23

23. Calls on the Commission to guarantee safety, quality and efficacy in any fast- track approval process and calls on the Commission and the Member States to explore synergies between regulatory bodies, HTA bodies and payers for facilitation timely patient’s access to innovative technologies as well as for defining conditions and eventual exit strategies for products that enter the market through such approval processes to introduce the concept of conditional authorisation based on effectiveness;

Amendment 464 #

Motion for a resolution
Paragraph 23

23. Calls on the Commission to take a very cautious approach and guarantee safety and efficacy in any fast- track approval process and to introduce the concept of conditional authorisation based on effectiveness; in this respect, calls on the Commission to take into consideration the opinion of non-industry related stakeholders;

Amendment 465 #

Motion for a resolution
Paragraph 23

23. Calls on the Commission to guarantee safety and efficacy in any fast- track approval process and to ~~introduce the concept of conditional authorisation based on effectiveness~~ensure that such approvals are made possible only in exceptional circumstances where a clear unmet medical need has been identified;

Amendment 466 #

Motion for a resolution
Paragraph 23

23. Calls on the Commission to guarantee safety and efficacy in any fast- track approval process and to introduce the concept of conditional authorisation based on effectiveness, within the scope of the circumstances identified in Regulation EC/507/2006;

Amendment 467 #

Motion for a resolution
Paragraph 23 a (new)

23a. Calls on the Commission to ensure that the fast access procedures respond to solid evidence in favour of potential health benefits and a real need for treating owing to an absence of effective alternatives without reducing patient safety or quality or effectiveness of treatment and in application of the evidence-based medicine criteria; calls for the transparency of each procedure and of clinical data to be guaranteed, including pharmacovigilence information, information on how citizens can obtain compensation and their right thereto following harm; calls on the Commission to ensure that all stakeholders, including HTA agencies, payers, patients and the European Parliament, participate in the study launched by the EMA in 2014 on adaptive licensing, given the potential importance of the new research and authorisation models;

Amendment 468 #

Motion for a resolution
Paragraph 23 a (new)

23a. Calls on the Commission to guarantee the independence of drug regulatory agencies from corporate influence and funding;

Amendment 469 #

José Inácio FARIA, Jasenko SELIMOVIC, Anneli JÄÄTTEENMÄKI, Marian HARKIN, Jana TOOM

Motion for a resolution
Paragraph 23 b (new)

23b. Calls on the Commission to work on new advances in the monitoring and pharmacovigilence of drugs by means of post-authorisation assessments on their effectiveness and adverse effects, and by means of a register for all adverse effects with closer collaboration between Member States’ agencies, and patients and doctors should have access to that register, which should be published every year; calls for the revision and harmonisation of the drugs labelling systems with a view to improving patient safety and enabling drugs to be traced in the EU;

Amendment 47 #

Motion for a resolution
Recital B a (new)

Ba. whereas the high prices of innovative medicines conflicts with the patients' and national health systems' ability to pay for pharmaceutical expenditure and hinders the fundamental right of citizens to health and medical treatment;

Amendment 470 #

Motion for a resolution
Paragraph 23 b (new)

23b. Calls on the Commission to ensure rigorous and proactive pharmacovigilance requirements, including the application of dissuasive sanctions if post-marketing requirements are not complied with;

Amendment 471 #

Motion for a resolution
Paragraph 24

24. Calls on the Commission to ~~set up a framework to promote, guarantee and reinforce the competitiveness of generic medicines, guaranteeing their faster entry onto the market and~~improve the competitiveness of generic medicines by monitoring unfair practices in accordance with Articles 101 and 102 of the TFEU~~, and to present a biannual report in this regard~~;

Amendment 472 #

Motion for a resolution
Paragraph 24

24. Calls on the Commission to set up a framework to promote, guarantee and reinforce the competitiveness and use of generic ~~medicine~~and biosimilar medicines in sustainable market conditions, guaranteeing their faster entry onto the market and monitoring unfair practices in accordance with Articles 101l and 1l 02 of the TFEU, and to present a biannual report in this regard;

Amendment 473 #

Motion for a resolution
Paragraph 24

24. Calls on the Commission to set up a framework to promote, guarantee and reinforce the competitiveness and use of generic ~~medicine~~and biosimilar medicines in sustainable market conditions, guaranteeing their faster entry onto the market and monitoring unfair practices in accordance with Articles 101 and 102 of the TFEU, and to present a biannual report in this regard;

Amendment 474 #

Motion for a resolution
Paragraph 24

24. Calls on the Commission to set up a framework to promote, guarantee and reinforce the competitiveness of generic ~~medicine~~and biosimilar medicines in sustainable market conditions, guaranteeing their faster entry onto the market and monitoring unfair practices in accordance with Articles 101 and 102 of the TFEU, and to present a biannual report in this regard;

Amendment 475 #

Motion for a resolution
Paragraph 24

24. Calls on the Commission to set up a framework to promote, guarantee and reinforce the competitiveness of generic and biosimilar medicines, guaranteeing their faster entry onto the market and sustainable conditions, and to monitor~~ing~~ unfair practices in accordance with Articles 101 and 102 of the TFEU, and to present a biannual report in this regard;

Amendment 476 #

Nicola CAPUTO

Motion for a resolution
Paragraph 24

24. Calls on the Commission to set up a framework to promote, guarantee and reinforce the competitiveness of generic medicines, guaranteeing their faster entry onto the market and monitoring unfair practices in accordance with Articles 101 and 102 of the TFEU, and to present a biannual report in this regard; also calls on the Commission to promote and coordinate a clear and transparent IT system so that consumers are able to compare various equivalent medicines to the original and choose which product they want on the basis of the active ingredient and the bulking agents used in the medicine;

Amendment 477 #

Motion for a resolution
Paragraph 24

24. Calls on the Commission to set up a framework to promote, guarantee and reinforce the competitiveness of generic and biosimilar medicines, guaranteeing their faster entry onto the market and monitoring unfair practices in accordance with Articles 101 and 102 of the TFEU, and to present a biannual report in this regard;

Amendment 478 #

Motion for a resolution
Paragraph 24

24. Calls on the Commission to set up a framework to promote, guarantee and reinforce the competitiveness of generic and biosimilar medicines, guaranteeing their faster entry onto the market and monitoring unfair practices in accordance with Articles 101 and 102 of the TFEU, and to present a biannual report in this regard;

Amendment 479 #

Motion for a resolution
Paragraph 24

24. Calls on the Commission to set up a framework to promote, guarantee and reinforce the competitiveness of generic and biosimilar medicines, guaranteeing their faster entry onto the market and monitoring unfair practices in accordance with Articles 101 and 102 of the TFEU, and to present a biannual report in this regard;

Amendment 48 #

José Inácio FARIA, Jasenko SELIMOVIC, Frédérique RIES, Marian HARKIN, Lieve WIERINCK

Motion for a resolution
Recital B a (new)

Ba. whereas patients should have access to the healthcare and treatment options of their choice and preference, including to complementary and alternative therapies and medicines;

Amendment 480 #

Motion for a resolution
Paragraph 24

24. Calls on the Commission to set up a framework to promote, guarantee and reinforce the competitiveness of generic and biosimilar medicines, guaranteeing their faster entry onto the market and monitoring unfair practices in accordance with Articles 101 and 102 of the TFEU, and to present a biannual report in this regard;

Amendment 481 #

Mireille D'ORNANO, Jean-François JALKH, Sylvie GODDYN

Motion for a resolution
Paragraph 24

24. Calls on the Commission to ~~set up a framework to~~ promote, guarantee and reinforce the competitiveness of generic medicines, guaranteeing their faster entry onto the market and monitoring unfair practices in accordance with Articles 101 and 102 of the TFEU, and to present a biannual report in this regard;

Amendment 482 #

Motion for a resolution
Paragraph 24 a (new)

24a. Calls on the Commission to analyse the impact of the existing rules outlined in Directive 2001/83/EC governing the marketing authorisation procedures of non-prescription homeopathic medicinal products on patients' choice, therapeutic freedom and ultimately access to medicines intended at self-medication;

Amendment 483 #

Motion for a resolution
Paragraph 24 a (new)

24a. Stresses that health technology assessments (HTA) are an important and effective instrument that contributes to the sustainability of national healthcare systems and creates incentives for innovations by rewarding them with high added value;

Amendment 484 #

Andrey KOVATCHEV, Cristian-Silviu BUŞOI, Kateřina KONEČNÁ, Biljana BORZAN, Karl-Heinz FLORENZ, Karin KADENBACH

Motion for a resolution
Paragraph 24 a (new)

24a. Underlines the importance of timely availability of generics and biosimilars in order to facilitate patients' access to pharmaceutical therapies and to improve the sustainability of national health systems;

Amendment 485 #

Motion for a resolution
Paragraph 24 a (new)

24a. Reiterates that European collaboration on HTA allows Member States to pool their expertise and use their resources more effectively, thus helping them to better meet the increasing demand for assessments;

Amendment 486 #

Motion for a resolution
Paragraph 24 a (new)

24a. calls on the Commission and encourages Member States to develop a strategy to stimulate new use of old drugs with the objective to ultimately fight against suboptimal use of current treatments and to tackle related inefficiencies impacting patient's life and the sustainability of the healthcare systems;

Amendment 487 #

Kateřina KONEČNÁ, Biljana BORZAN

Motion for a resolution
Paragraph 24 a (new)

24a. Calls on the Commission to observe and reinforce the EU competition legislation and its competencies on the pharmaceutical market to counter abuse and to promote fair prices for patients;

Amendment 488 #

Motion for a resolution
Paragraph 24 b (new)

24b. Calls on the European Commission to enhance dialogue on unmet medical needs between all relevant stakeholders, patients, healthcare professionals, regulators, HTA bodies, payers and developers throughout the life span of medicines.

Amendment 489 #

Motion for a resolution
Paragraph 25

25. Calls on the Commission to propose legislation on a European system for health technology assessment as soon as possible, and to assess added-value medicines compared with the best available alternative; also calls on the Commission to harmonise pricing and reimbursement criteria tocontinue supporting cooperation between MS on HTA through the HTA Network and EUnetHTA and to continue to investigate the feasibility and added value of further streamlining national health technology assessments, takeing into account the ~~level of innovation and the social and economic cost-benefit analysis, and to put in place a European classification on the added value level of medicine~~specificities of national pricing and reimbursement systems;

Amendment 49 #

Alojz PETERLE

Motion for a resolution
Recital B a (new)

Ba. whereas patients should have access to the healthcare and treatment options of their choice and preference, including to complementary and alternative therapies and medicines;

Amendment 490 #

Elisabetta GARDINI, Giovanni LA VIA, Aldo PATRICIELLO, Alessandra MUSSOLINI

Motion for a resolution
Paragraph 25

25. Calls on the Commission to propose legislation on a European system for health technology assessment as soon as possible, and to assess added-value medicines compared with the best available alternative; also calls on the Commission to harmonise pricing and reimbursement criteria to take into account the level of innovation and the social and economic cost-benefit analysis, and to put in place a Europeanduce a report analysing the current different national systems for classification on the added value level of medicines in the EU and beyond;

Amendment 491 #

Motion for a resolution
Paragraph 25

Amendment 492 #

Motion for a resolution
Paragraph 25

Amendment 493 #

Mireille D'ORNANO

Motion for a resolution
Paragraph 25

25. Calls on the Commission to propose legislation on a European system for health technology assessment as soon as possible, and to assess added-value medicines compared with the best available alternative; also calls on the Commission to harmonise pricing and reimbursement criteria to take into account the level of innovation and the social and economic cost-benefit analysis, and to put in placeess for the added value of medicines to be factored in when they are compared with the best available alternative; also calls on the Commission to support a European classification on the added value level of medicines;

Amendment 494 #

Motion for a resolution
Paragraph 25

25. Calls on the Commission to propose legislation on a European system for health technology assessment as soon as possible, ~~and to assess added-value medicines~~to facilitate assessment of compared with the best available alternative; ~~also calls on the Commission to harmonise pricing and reimbursement criteria to take into account the level of innovation and the social and economic cost-benefit analysis, and~~such legislation shall ensure that HTA output jointly produced at EU level is user in national decision making process. It shall reflect the differences between pharmaceuticals and other medical technologies and procedures. It shall foresee joint Rapid Relative Effectiveness Assessment for pharmaceutical, strengthen early dialogues. it should consider a coordination mechanisms based on an independent body, which could foster cooperation between national HTA bodies and at the same time ensuring that expertise on HTA remains within national (and regional) HTA bodies. Could be helpful to put in place a European cClassification on the added value level of medicines;

Amendment 495 #

Motion for a resolution
Paragraph 25

25. Calls on the Commission to propose legislation on a European system for health technology assessment ~~as soon as possible,~~ and to assess added-value medicines compared with the best available alternative; also calls on the Commission to ~~harmonise pricing and reimbursement criteria to take into account the level of innovation and the social and economic cost-benefit analysis,~~promote early dialogue with companies that develop new health technologies, introduce compulsory relative effectiveness assessments at EU level as a first step for new medicines, ensure that joint HTA information at national level can be reused to harmonise processes and methods to prevent unnecessary overlaps, and address any financing and organisational issues with regard to this new system; also calls on the Commission to take into account the degree of innovation and to put in place a European classification on the added value level of medicines;

Amendment 496 #

Motion for a resolution
Paragraph 25

Amendment 497 #

Motion for a resolution
Paragraph 25

25. Calls on the Commission to propose legislation on a European system for health technology assessment as soon as possible, and to assess added-value medicines compared with the best available alternative; also calls on the Commission to harmonise pricing and reimbursement criteria throughout the EU to take into account the level of innovation and the social and economic cost-benefit analysis, and to put in place a European classification on the added value level of medicines; calls for simplifying the reimbursement criteria and process of the medicals costs in another country than their own

Amendment 498 #

Motion for a resolution
Paragraph 25

25. Calls on the Commission to consider proposeing legislation on ~~a European system for~~these aspects of the health technology assessment ~~as soon as possible, and to~~which are relevant for the EU, in particular clinical evaluation, to better assess added-value medicines compared with the best available alternative; also calls on the Commission to ~~harmonise~~work towards pricing and reimbursement criteria t~~o take~~aking into account the level of innovation and the social and economic cost-benefit analysis for all the Member States, and to put in place a European classification on the added value level of medicines;

Amendment 499 #

Motion for a resolution
Paragraph 25

25. Calls on the Commission to ~~propose legislation~~carry out an impact assessment on a European system for health technology assessment as soon as possible, and to assess added-value medicines compared with the best available alternative; ~~also calls on the Commission to harmonise pricing and reimbursement criteria to take into account the level of innovation and the social and economic cost-benefit analysis,~~ and to put in place a European classification on the added value level of medicines;

Amendment 5 #

Motion for a resolution
Citation 1 c (new)

- having regard to the HTA Network Strategy for EU Cooperation on Health Technology Assessment of 29 October 20141b, __________________ 1b http://ec.europa.eu/health/technology_ass essment/docs/2014_strategy_eucooperatio n_hta_en.pdf

Amendment 50 #

Motion for a resolution
Recital B a (new)

Ba. whereas the third Sustainable Development Goal of the United Nations is to ensure healthy lives and promote well-being for all at all ages;

Amendment 500 #

Motion for a resolution
Paragraph 25

25. ~~Calls on the Commission to propose legislation on a European system for health technology assessment as soon as possible, and to assess~~Welcomes the HTA multi-annual work programme 2016-2020 and recognises the added- value medicines compared with the best available alternative; also calls on the Commission to harmonise pricing and reimbursement criteria to take into account the level of innovation and the social and economic cost-benefit analysis, and to put in place a European classificof European cooperation when it comes to assessing health technology; calls on the Commission to propose legislation on establishing a system for health technology assessment as soon as possible; calls for that system to be developed in close collaboration onwith the ~~added value level of medicines;~~European Medicines Agency.

Amendment 501 #

Motion for a resolution
Paragraph 25

Amendment 502 #

Motion for a resolution
Paragraph 25

Amendment 503 #

Motion for a resolution
Paragraph 25 a (new)

25a. Calls on the Commission and the Member States to identify and/or develop frameworks, structures and methodologies in order to meaningfully incorporate patient evidence at all stages of the medicines R&D cycle, from early dialogue to regulatory approval, Health Technology Assessment, relative effectiveness assessments, and pricing and reimbursement decision-making with the involvement of patients and their representative organisations.

Amendment 504 #

Motion for a resolution
Paragraph 25 a (new)

25a. Calls on the Commission and the Member States to identify and develop frameworks, structures and methodologies in order to meaningfully incorporate patient evidence at all stages of the medicines R&D cycle, from early dialogue to regulatory approval, Health Technology Assessment, relative effectiveness assessments, and pricing and reimbursement decision-making with the involvement of patients and their representative organisations;

Amendment 505 #

Elisabetta GARDINI, Alojz PETERLE, Giovanni LA VIA, Aldo PATRICIELLO, Alessandra MUSSOLINI

Motion for a resolution
Paragraph 25 a (new)

25a. Calls on the Commission to analyse the economic, social and ethical criteria which some Member States’ HTAs already apply and to establish common principles or guidelines in that regard on the basis of the usefulness of those criteria with regarding to pricing and reimbursement, then to decide whether the innovation quality is important to establishing its economic value, but not important enough to guarantee an appropriate cost- effectiveness relationship;

Amendment 506 #

Motion for a resolution
Paragraph 25 a (new)

25a. Calls on the European Medicines Agency to assess added-value medicines compared with the best available alternative; also calls on the Commission to harmonise pricing and reimbursement criteria to take into account the level of innovation and the social and economic cost-benefit analysis, and to put in place a European classification on the added value level of medicines;

Amendment 507 #

Nicola CAPUTO, Marc TARABELLA, Soledad CABEZÓN RUIZ

Motion for a resolution
Paragraph 25 a (new)

25a. Calls on the Commission to establish a permanent and single mechanism assessing relative efficacy of new medicinal products at EU level based on harmonized data requirements, so as to enhance patient access to new treatments and avoid duplications in drug assessments;

Amendment 508 #

Motion for a resolution
Paragraph 25 a (new)

Amendment 509 #

Andrey KOVATCHEV, Cristian-Silviu BUŞOI, Kateřina KONEČNÁ, Biljana BORZAN, Karl-Heinz FLORENZ, Karin KADENBACH

Motion for a resolution
Paragraph 26

26. Calls on the Commission and the Member States to promote major publicly funded investment in research based on medical needs, and to introduce conditional funding based on affordable end pricing and non-exclusive licencing; at the same time, given that the violent economic adjustment imposed by the EU does not permit each Member State to tackle the deficits observed in the health system, considers that the Union should take immediate steps to cover these deficits;

Amendment 51 #

Motion for a resolution
Recital B a (new)

Ba. whereas pharmaceuticals are one of the main pillars of healthcare rather than mere objects of trade;

Amendment 510 #

Mireille D'ORNANO, Jean-François JALKH, Sylvie GODDYN

Motion for a resolution
Paragraph 26

Amendment 511 #

Motion for a resolution
Paragraph 26

26. Calls on the Commission and the Member States to promote major publicly funded investment in research based on medical needs, and to introduce conditional funding based on affordable end pricing ~~and~~, non-exclusive licencing, and results yielded by biomedical research in the form of suitable and affordable medicines;

Amendment 512 #

Motion for a resolution
Paragraph 26

26. Calls on the Commission and the Member States to promote major publicly funded investment in research based on unmet medical needs, and to introduce conditional funding based on affordable end pricing and non-exclusive licencing;

Amendment 513 #

Motion for a resolution
Paragraph 26

26. Calls on the Commission and the Member States to promote major publicly funded investment in research based on medical needs~~, and to introduce conditional funding based on affordable end pricing and non-exclusive licencing~~; further encourages Member States to ensure that their pricing and reimbursement frameworks guide private investment towards those innovations which they expect to deliver the desired benefits and patient outcomes;

Amendment 514 #

Motion for a resolution
Paragraph 26 a (new)

26a. Calls on Member States to ensure that their pricing and reimbursement systems and pharmaceutical policies effectively convey a long term policy vision, therefore creating a more predictable operating environment for all actors of the healthcare system, including pharmaceutical companies, ultimately supporting patient access to medicines throughout the whole lifecycle of molecules and incentivizing innovation;

Amendment 515 #

Motion for a resolution
Paragraph 26 a (new)

26a. Calls on the European Medicines Agency to assess added-value medicines compared with the best available alternative; also calls on the European Commission to harmonize pricing and reimbursement criteria, to take into account the level of innovation as well as the social and economic cost-benefit analysis, and to put in place a European classification on the added value of medicines;

Amendment 516 #

Mireille D'ORNANO, Jean-François JALKH, Sylvie GODDYN

Motion for a resolution
Paragraph 26 a (new)

26a. calls on the Commission to take measures to promote the development of drugs for preventative and curative geriatrics, and access to innovative drugs for patients suffering from mesothelioma and amyotrophic lateral sclerosis (ALS);

Amendment 517 #

Motion for a resolution
Paragraph 27

27. Calls on the Council to increase cooperation between the Member States as regards price-setting procedures~~, in order to share information about prices, reimbursement, negotiation agreements and good practices and to avoid unnecessary administrativ~~; emphasises that the European Medicines Agency would benefit from developing the assessment of the ‘medical service delivered’ by medicines on the basis of several satisfaction levels and the ‘improvement of the medical service delivered’ with a view to comparing the latter with the tre~~quire~~atments ~~and delay~~that already existed, as the French Health Authority already does;

Amendment 518 #

Alberto CIRIO

Motion for a resolution
Paragraph 27

27. Calls on the Council to ~~increase coope~~support the exchange of good practionces between ~~the~~ Member States as regards price-setting procedures, in order to share information about prices, reimbursement, negotiation agreements and good practices and to avoid unnecessary administrative requirements and delayson those aspects where cooperation can lead to broader and faster patient access, while also preserving necessary incentives for innovation;

Amendment 519 #

José Inácio FARIA, Jasenko SELIMOVIC, Anneli JÄÄTTEENMÄKI, Jana TOOM

Motion for a resolution
Paragraph 27

27. Calls on the Council toand the Commission to promote increased cooperation between the Member States as regards price-setting procedures, in order to share information about prices, reimbursement, negotiation agreements and good practices and to avoid unnecessary administrative requirements and delays;

Amendment 52 #

Motion for a resolution
Recital B a (new)

Ba. whereas insufficient access to essential medicinal products poses a serious threat to the well-being

Amendment 520 #

Lieve WIERINCK, Gesine MEISSNER, Frédérique RIES, José Inácio FARIA, Anneli JÄÄTTEENMÄKI, Marian HARKIN, Jana TOOM, Jasenko SELIMOVIC

Motion for a resolution
Paragraph 27

27. Calls on the Council to increase cooperation between the Member States as regards price-setting procedures, in order to share information about prices, reimbursement~~, negotiation agreements~~ and good practices and to avoid unnecessary administrative requirements and delays;

Amendment 521 #

Motion for a resolution
Paragraph 27

27. Calls on the Council to increase cooperation between the Member States as regards price-setting procedures, in order to share information about prices, reimbursement, negotiation agreements and good practices and to avoid unnecessary administrative requirements and delays, ensuring faster patient access to innovative medicines;

Amendment 522 #

Elisabetta GARDINI, Alojz PETERLE, Giovanni LA VIA, Aldo PATRICIELLO, Alessandra MUSSOLINI

Motion for a resolution
Paragraph 27

27. Calls on the Council to increase cooperation between the Member States as regards price-setting procedures, in order to share information about prices, reimbursement, negotiation agreements and good practices and to avoid unnecessary administrative requirements and delays, based also on the work of the EURIPID project and existing bilateral and multilateral collaborations;

Amendment 523 #

Motion for a resolution
Paragraph 27

27. Calls on the Council to increase cooperation between the Member States as regards price-setting procedures, in order to share information about prices, reimbursement, negotiation agreements and good practices and to avoid unnecessary administrative requirements and delays, based also on the work of EURIPID project and existing bilateral and multilateral collaborations;

Amendment 524 #

Motion for a resolution
Paragraph 27

27. Calls on the Council to increase cooperation between the Member States as regards price-setting procedures, in order to share information about prices, reimbursement, negotiation agreements and good practices and to avoid unnecessary administrative requirements and delays; also calls on the Council to ensure that Member States make greater use of the mutual recognition of authorisations;

Amendment 525 #

Nicola CAPUTO, Marc TARABELLA, Soledad CABEZÓN RUIZ

Motion for a resolution
Paragraph 27

27. Calls on the Council to i~~ncrease cooper~~mprove communication between the Member States as regards price-setting procedures, in order to share information about prices, reimbursement, negotiation agreements and good practices and to avoid unnecessary administrative requirements and delays;

Amendment 526 #

Motion for a resolution
Paragraph 27

27. Calls on the Council to increase cooperation and dialogue between the Member States as regards price-setting procedures, in order to share information about prices, reimbursement, negotiation agreements and good practices and to avoid unnecessary administrative requirements and delays;

Amendment 527 #

Motion for a resolution
Paragraph 27 a (new)

27a. Invites the Member States to explore possible strategies on voluntary cooperation to jointly work on relative efficacy assessments of medicines, on common horizon scanning tools to allow for better budgetary planning and on measures enabling joint price negotiations in coalitions of Member States, that have expressed interest to do so;

Amendment 528 #

Margrete AUKEN, Michèle RIVASI

Motion for a resolution
Paragraph 27 a (new)

27a. Calls on the Commission to consider a model in which a maximum price for a pharmaceutical product is set when approved for the European Market by EMA in accordance with Directive 2001/83/EC and Regulation 2004/726/EC; this maximum price should be based on the cost of research, development and production with a fair profit margin;

Amendment 529 #

Motion for a resolution
Paragraph 27 a (new)

27a. Calls on the EPO and the Member States to grant patents on health products that strictly fulfil the patentability requirements of novelty, inventive step and industrial applicability; a mere discovery of a new form of a known substance that does not improve efficacy should not be patentable;

Amendment 53 #

Nicola CAPUTO, Marc TARABELLA, Soledad CABEZÓN RUIZ

Motion for a resolution
Recital B b (new)

Bb. whereas with a 20% return on investment, the pharmaceutical sector is one of the EU’s most competitive, but it also creates 800 000 jobs and turns over EUR 200 billion per year; whereas the sector is facing up to important competitors such as the United States and the Asian market, and as a result strategies need to be put in place to enable it to become more competitive, for which quality of innovation may be key;

Amendment 530 #

Motion for a resolution
Paragraph 27 b (new)

27b. Invites the Member States to consider organising during each EU Presidency an informal meeting of relevant high level representatives from the Member States responsible for pharmaceutical policy (e.g. national directors of pharmaceutical policy), encouraging strategic reflection and discussion on current and future developments in the pharmaceutical system in the EU and its Member States; notes that these discussions could be used, where relevant, as an input for further reflection in the appropriate EU fora, in particular the Working Party on Pharmaceuticals and Medical Devices;

Amendment 531 #

Damiano ZOFFOLI

Motion for a resolution
Paragraph 28

28. Calls on the Council to promote a more rational use of medicines across the EU, and to promote campaigns and educational programmes aimed at making citizens aware of how to use medicines responsibly and on the collection of medicines that have not yet expired, the latter representing a precious asset to the poor, a huge waste and a serious financial loss for national health systems, without forgetting the negative consequences of disposal on the environment;

Amendment 532 #

Mireille D'ORNANO, Sylvie GODDYN, Jean-François JALKH

Motion for a resolution
Paragraph 28

28. Calls on the Council to promote rational use of medicines across the EU, including by limiting wastage through excessive use of medicines or prescriptions which are inappropriate to patients’ illnesses; in fact, this challenge amounts to several millions of euros which could be put to better use elsewhere;

Amendment 533 #

Lieve WIERINCK, Frédérique RIES, Gesine MEISSNER, José Inácio FARIA, Anneli JÄÄTTEENMÄKI, Marian HARKIN, Jana TOOM, Jasenko SELIMOVIC

Motion for a resolution
Paragraph 28

28. Calls on the Council to promote rational use of medicines across the EU, including a better use of pharmacist expertise in procurement and patient advice;

Amendment 534 #

Motion for a resolution
Paragraph 28

28. Calls on the Council to promote rational use of medicines across the EU, such as avoiding overconsumption of medicines, in particular antibiotics;

Amendment 535 #

Karl-Heinz FLORENZ, Peter LIESE, Françoise GROSSETÊTE, Norbert LINS, Andrey KOVATCHEV

Motion for a resolution
Paragraph 28

28. Calls on the Council to promote rational use of medicines, and especially antimicrobials, across the EU;

Amendment 536 #

Motion for a resolution
Paragraph 28 a (new)

28a. Stresses that antimicrobial resistance has become a serious problem that needs to be urgently tackled; therefore calls on the Commission and the Member States to tackle the key scientific, regulatory and economic challenges facing the development of antimicrobial agents, particularly by creating incentives for investments in research and development as well as new financing models to address the most urgent needs of the public healthcare sector and at the same time safeguard the sustainability of public healthcare systems in order to improve and ensure future access to suitable antimicrobial agents;

Amendment 537 #

Jana TOOM, Ilhan KYUCHYUK, Marian HARKIN

Motion for a resolution
Paragraph 28 a (new)

28a. Calls on the Member States, where the private sector fails to deliver on availability and/or affordability of medicines listed on the WHO list of essential medicines, to cooperate in setting up public facilities for medicines production, while those medicines should be produced and sold in the EU at a price not exceeding the cost of production;

Amendment 538 #

Motion for a resolution
Paragraph 28 a (new)

28a. Call on the Member States to ensure accessibility of pharmacies, including their density in both urban and rural areas, professional staff number, appropriate opening hours, qualitative advice and counselling service;

Amendment 539 #

Motion for a resolution
Paragraph 28 a (new)

28a. Calls on the Commission, the Council and the Member States to operationalize funding for R&D through delinkage innovation models with a view to addressing antimicrobial resistance and the related challenges;

Amendment 54 #

José Inácio FARIA, Jasenko SELIMOVIC, Anneli JÄÄTTEENMÄKI, Frédérique RIES, Marian HARKIN, Lieve WIERINCK, Jana TOOM

Motion for a resolution
Recital B b (new)

Bb. whereas access to innovative healthcare is to be conceived not only as access to new medicines containing an active substance or combination of active substances that has not been authorised before, but also as access to new tools, standards and approaches to therapies that bring a meaningful improvement over existing treatment with respect to outcomes that matter to patients;

Amendment 540 #

Motion for a resolution
Paragraph 28 a (new)

28a. Calls on the Commission and on Member States to ensure full implementation of the pharmacovigilance legislation;

Amendment 541 #

Jana TOOM, Ilhan KYUCHYUK, Marian HARKIN

Motion for a resolution
Paragraph 28 b (new)

28b. Call on the Member States to ensure that for the protection of health and life and in the interests of consumer protection information notes accompanying medicines are provided by retailers in widely used languages of a particular Member State in addition to official language or languages;

Amendment 542 #

Andrey KOVATCHEV, Cristian-Silviu BUŞOI, Kateřina KONEČNÁ, Biljana BORZAN, Karin KADENBACH

Motion for a resolution
Paragraph 29

29. Calls on the Commission and the Council to ~~explore new measures to control prices, such as horizontal scanning~~develop a framework for ensuring "fair access" that maximises patient access and societal benefit whilst avoiding unacceptable impact on healthcare budgets; including exploration of different measures, such as horizon scanning, early dialogue, innovative pricing models, mechanisms for systematic collection of real-world data, and coordinating joint procurements;

Amendment 543 #

Karl-Heinz FLORENZ, Ivo BELET

Motion for a resolution
Paragraph 29

29. Calls on the Commission and the Council to explore new ~~measures to control prices, such as horizontal scanning and coordinating joint procurements~~initiatives that predict developments in the pharmaceutical market and prices, such as horizontal scanning and voluntary cooperation in price negotiations and joint procurements, as is the case in the initiative between the Benelux countries and Austria;

Amendment 544 #

Motion for a resolution
Paragraph 29

29. Calls on the Commission and the Council to explore new measures to ~~control price~~address uncertainty on the expected budget impact ant to make sure that products are available in the markets, such as horizon~~tal~~ scanning and coordinating joint procurements;

Amendment 545 #

Motion for a resolution
Paragraph 29

29. Calls on the Commission and the Council to explore new measures to control prices, such as horizontal scanning ~~and~~, coordinating joint procurements and the evolution of healthcare public expenditures;

Amendment 546 #

Motion for a resolution
Paragraph 29

29. Calls on the Commission and the Council to explore new measures to control p~~rices~~ublic expenditure on health care, such as horizontal scanning and coordinating joint procurements;

Amendment 547 #

Motion for a resolution
Paragraph 29

29. Calls on the Commission and the Council to explore in justified cases new measures to control prices, such as horizontal scanning and coordinating joint procurements;

Amendment 548 #

Motion for a resolution
Paragraph 29

29. Calls on the Commission and the Council to explore new improved measures to control prices, such as horizontal scanning and coordinating joint procurements;

Amendment 549 #

Mireille D'ORNANO, Jean-François JALKH, Sylvie GODDYN

Motion for a resolution
Paragraph 29

29. Calls on the Commission and the ~~Council~~Member States to explore new measures to control prices, such as horizontal scanning and ~~coordin~~facilitating joint procurements;

Amendment 55 #

Motion for a resolution
Recital B b (new)

Bb. whereas Member States have sovereignty, in particular, over decisions on whether their national health systems should provide reimbursement for pharmaceutical products;

Amendment 550 #

Motion for a resolution
Paragraph 29 a (new)

29a. calls on the Commission to define with all relevant stakeholders how best the most advantageous economic tender (MEAT) criterion, as described in the Public Procurement Directive, and which does not imply only the lower cost criteria, could apply to medicines tenders in hospitals at national level, in order to enable sustainable and responsible supply of medicines; encourages Member States to best transpose the most economic advantageous tender criterion for medicinal products in their national legislation;

Amendment 551 #

Lieve WIERINCK, Frédérique RIES, Gesine MEISSNER, José Inácio FARIA, Marian HARKIN, Ulrike MÜLLER, Jana TOOM, Jasenko SELIMOVIC

Motion for a resolution
Paragraph 29 a (new)

29a. Calls on the Member States to enter into dialogue with all the relevant stakeholders, such as patient organisations, paying agencies, healthcare professionals and industry, with the aim of establishing short-, medium- and long term holistic strategies for access to medicines, ensuring the sustainability of healthcare systems and a competitive pharmaceutical industry, leading to faster access for patients and affordable prices;

Amendment 552 #

Motion for a resolution
Paragraph 29 a (new)

29a. Calls on the Commission to launch a new high-level European strategic dialogue for the pharmaceutical sector that brings together representatives of the Commission, the European Parliament and the Member States, along with key stakeholders from the healthcare world: payers, patients, representatives from the academic and scientific world and manufacturers, including SMEs;

Amendment 553 #

Motion for a resolution
Paragraph 30

30. Calls on the Commission and the Council to define clear rules on incompatibility, conflicts of interest and transparency in the EU institutions and for experts involved in issues related to medicines; calls on the experts involved in the authorisation process to publish their CVs and to sign a declaration of absence of conflict of interest;

Amendment 554 #

Motion for a resolution
Paragraph 30 a (new)

30a. Calls on the Member States, under the supervision of the Commission, to enact the regulation on clinical trials in the scope of transparency and to study open access to those trials once they have been authorised for the market, and to push for the publication of all of the clinical trial results, including negative data, with a view to fostering research and economic growth;

Amendment 555 #

Motion for a resolution
Paragraph 30a (new)

30a. Calls on the Commission and national antitrust authorities to monitor unfair practices to protect consumers from artificially high prices of medicines;

Amendment 556 #

Motion for a resolution
Paragraph 31

~~31. Calls on the Commission to propose a new directive on transparency of price-setting procedures and reimbursement systems, taking into account the challenges of the market;~~deleted

Amendment 557 #

Elisabetta GARDINI, Giovanni LA VIA, Aldo PATRICIELLO, Alessandra MUSSOLINI

Motion for a resolution
Paragraph 31

31. Calls on the Commission to propose a new directive on transparency ~~of price-setting procedures and reimbursement systems, taking into account the challenges of the market~~containing measures to regulate the setting of prices of speciality medicines for human consumption and their inclusion in national health insurance regimes, to guarantee full transparency and effective controls over all procedures used to establish prices and the reimbursement of medicines in the Member States of the EU;

Amendment 558 #

Motion for a resolution
Paragraph 31

31. Calls on the Commission to ~~propose a new directive on transparency of price-setting procedures and reimbursement systems, taking into account the challenges of the market~~review the existing EU Directive 89/105/EEC, and in particular to put in place more solid implementing measures to ensure that Member States abide to the limit of 180 days imposed to them to fix the price of new medicines approved by EMA (Article 6);

Amendment 559 #

Motion for a resolution
Paragraph 31

31. Calls on the Commission to ~~propose a new directive on transparency of price-setting procedures and reimbursement systems, taking into account the challenges of the market~~review the existing EU Directive 89/105/EEC and in particular to put in place more solid implementing measures to ensure that Member states abide to the limit of 180 days imposed to them to fix the price of new medicines approved by EMA (Article 6);

Amendment 56 #

Motion for a resolution
Recital B b (new)

Bb. whereas universal access to medicines depends on their timely availability and their affordability for everyone, without any geographical discrimination;

Amendment 560 #

Motion for a resolution
Paragraph 31

31. Calls on the Commission to propose a new directive on transparency of price-setting procedures and reimbursement systems, with a view to extending transparency to the market authorisation holder, and taking into account the challenges of the market;.

Amendment 561 #

Motion for a resolution
Paragraph 31

Amendment 562 #

Motion for a resolution
Paragraph 31

31. Calls on the Commission to propose a new directive on transparency of price-setting procedures and reimbursement systems, taking into account the challenges of the market and the division of competences between the EU and its Member States;

Amendment 563 #

Motion for a resolution
Paragraph 31

31. Calls on the Commission to propose a new directive on transparency of price-setting procedures, of real costs of R&D and marketing and reimbursement systems, taking into account the challenges of public budgets and of the market;

Amendment 564 #

Mireille D'ORNANO, Jean-François JALKH, Sylvie GODDYN

Motion for a resolution
Paragraph 31

31. Calls on the Commission to propose a new directive on transparency of price-setting procedures and reimbursement systems, taking into account the cha~~lle~~nges of the market;

Amendment 565 #

Motion for a resolution
Paragraph 31

31. Calls on the Commission to ~~propose a new directive on~~support transparency of price-setting procedures and reimbursement systems, taking into account the challenges of the market;

Amendment 566 #

Motion for a resolution
Paragraph 32

32. Calls on the Commission and the Court of Justice of the European Union to clarify, in accordance with Article 102 of the TFEU, what constitutes an abuse of a dominant position due to high prices; and to limit the parallel trade of pharmaceuticals as it leads to shortages;

Amendment 567 #

Motion for a resolution
Paragraph 32

Amendment 568 #

Motion for a resolution
Paragraph 32 a (new)

32a. Calls on the Commission to continue and where possible intensify the monitoring, and investigation of potential cases of market abuse including so called "pay for delay", excessive pricing as well as other market restrictions specifically relevant to the pharmaceutical companies operating within the EU, in accordance with Articles 101 and 102 of the Treaty on Functioning of the European Union;

Amendment 569 #

Motion for a resolution
Paragraph 32a (new)

32a. Calls on the Commission and the Member States to stop concluding free- trade agreements that could seriously damage health systems and compromise the principle of universal access to medicines, along with the principle of universal access to health services;

Amendment 57 #

Andrey KOVATCHEV, Cristian-Silviu BUŞOI, Kateřina KONEČNÁ

Motion for a resolution
Recital B b (new)

Bb. whereas general concern exists in the society and authorities on access to medicines in Europe and on sustainability of health system

Amendment 570 #

Motion for a resolution
Paragraph 32 a (new)

32a. Calls on the Commission to take note of the scale of the problem with parallel export of pharmaceuticals within the EU, as well as of the margin of discretion of the Member States when justifying measures on public health grounds;

Amendment 571 #

Motion for a resolution
Paragraph 33

33. ~~Calls on the Commission and the~~ Strongly supports Member States t~~o make~~hat intend to use of the safeguard and flexibilitiy clauses under the WTO TRIPS Agreement ~~and to coordinate and clarify their use when necessary~~to protect and promote public health, and calls on the Commission to coordinate efforts in this regard; calls on the EU to stop discriminating against countries such as India that have implemented progressive IP policies that promote access to medicines in the interest of the health of their citizens, through its watch-list of ‘priority countries’;

Amendment 572 #

Motion for a resolution
Paragraph 33

33. Calls on the Commission and the Member States to make use of the flexibilities under the WTO TRIPS Agreement and to coordinate and clarify their use when necessary; recalls that no undue political and economic pressures should be used to dissuade governments from using the flexibilities that could protect public health;

Amendment 573 #

Motion for a resolution
Paragraph 33 a (new)

33a. Calls on the Council and the Commission to safeguard access to clinical trial and pharmacovigilance data from any trade secret or commercial confidentiality provisions in international trade negotiations, as well as information exchanged between parties' national authorities as regards matters of safety and overriding public interest;

Amendment 574 #

Motion for a resolution
Paragraph 33 b (new)

33b. Calls on the Council and the Commission to exclude any provisions concerning price and reimbursement criteria or procedures from international trade negotiations;

Amendment 575 #

Motion for a resolution
Paragraph 33 c (new)

33c. Calls on the Council and the Commission to fully safeguard the practicability of biomedical innovation models other than patent-based intellectual property regimes in international trade negotiations;

Amendment 576 #

Motion for a resolution
Paragraph 34

~~34. Calls on the Commission to examine and compare the prices of medicines in the EU and to present an annual report to Parliament in this regard;~~deleted

Amendment 577 #

José Inácio FARIA, Jasenko SELIMOVIC, Marian HARKIN, Jana TOOM

Motion for a resolution
Paragraph 34

34. Calls on the Commission to examine and compare the ~~pri~~access tof medicines in the EU and to present an annual report to Parliament in this regard;

Amendment 578 #

Motion for a resolution
Paragraph 34

34. Calls on the Commission to examine and compare the actual prices of medicines in the EU and to present an annual report to the Council and to the European Parliament in this regard;

Amendment 579 #

Motion for a resolution
Paragraph 34

34. Calls on the Commission to examine and compare the prices of medicines in the EU, together with access to medicines, and to present an annual report to Parliament in this regard;

Amendment 58 #

Motion for a resolution
Recital B c (new)

Bc. whereas trade and investment agreements regularly contain TRIPS-plus provisions that increase levels of intellectual property protection and enforcement that impede the ability of parties to use laws and policies promoting their human rights obligations to the fullest extent possible;

Amendment 580 #

Andrey KOVATCHEV, Cristian-Silviu BUŞOI, Kateřina KONEČNÁ

Motion for a resolution
Paragraph 34

34. Calls on the Commission to examine and compare, to the extent possible, the prices of medicines in the EU and to present an annual report to Parliament in this regard;

Amendment 581 #

Karin KADENBACH

Motion for a resolution
Paragraph 34

34. Calls on the Commission to examine and compare the actual prices of medicines in the EU and to present an annual report to Parliament in this regard;

Amendment 582 #

Motion for a resolution
Paragraph 34

34. Calls on the Commission to examine and compare ~~the prices of~~access to medicines in the EU and to present an annual report to Parliament in this regard;

Amendment 583 #

Motion for a resolution
Paragraph 35

~~35. Calls for the creation of a European Parliament task force to monitor the prices of medicines;~~deleted

Amendment 584 #

Motion for a resolution
Paragraph 35

~~35. Calls for the creation of a European Parliament task force to monitor the prices of medicines;~~deleted

Amendment 585 #

Motion for a resolution
Paragraph 35

~~35. Calls for the creation of a European Parliament task force to monitor the prices of medicines;~~deleted

Amendment 586 #

Motion for a resolution
Paragraph 35

~~35. Calls for the creation of a European Parliament task force to monitor the prices of medicines;~~deleted

Amendment 587 #

Motion for a resolution
Paragraph 35

~~35. Calls for the creation of a European Parliament task force to monitor the prices of medicines;~~deleted

Amendment 588 #

Motion for a resolution
Paragraph 35

35. Calls for the creation of a European Parliament task force to monitor the ~~pri~~access tof medicines;

Amendment 589 #

Motion for a resolution
Paragraph 35 a (new)

35a. Calls on the Commission to recommend measures to improve the rate of approval of novel therapies and their supply to patients;

Amendment 59 #

Motion for a resolution
Recital B c (new)

Bc. having regard to the conclusions of the Council on robust and sustainable health systems, and reforms for sustainable health systems (efficiency, quality of innovation and prevention) of 2014,

Amendment 590 #

Motion for a resolution
Paragraph 36

36. Calls on the Commission to better define the concept, and analyse the causes of, medicines shortages, from the perspective of timely patient access, to establish a list of essential medicines and monitor compliance with Article 81 of Directive 2001/83/EU on shortages of supply, ~~and to promote the supply of generic~~which are to be reported on by the Commission on an annual basis, to promote the supply of generics, and to seek solutions to secure the continued availability of effective but commercially discontinued medicines;

Amendment 591 #

José Inácio FARIA, Jasenko SELIMOVIC, Anneli JÄÄTTEENMÄKI, Marian HARKIN, Jana TOOM

Motion for a resolution
Paragraph 36

36. Calls on the Commission to define ‘shortage’ and to analyse the causes of the shortages in the EU, to establish a ~~list of essential medicines and~~European list of essential medicines which uses as a reference the WHO’s list of essential medicines and a database on the medicines handled by the EMA, to monitor compliance with Article 81 of Directive 2001/83/EUC on shortages of supply, and to promote the supply of generics, and to draw up a report in that respect on an annual basis;

Amendment 592 #

Motion for a resolution
Paragraph 36

36. Calls on the Commission to analyse the causes of shortages, to establish a list of essential medicines and monitor compliance with Article 81 of Directive 2001/83/EU on shortages of supply, to explore mechanisms to address the withdrawal of effective medicines from the market purely for commercial reasons, such as remarketing for new indications, and to promote the supply of generics;

Amendment 593 #

Motion for a resolution
Paragraph 36

Amendment 594 #

Motion for a resolution
Paragraph 36

36. Calls on the Commission to analyse the causes of shortages, to establish a list of essential medicines and monitor compliance with Article 81 of Directive 2001/83/EU on drug shortages ~~of supply~~and the withdrawal from the market of efficient drugs for purely commercial reasons, and to promote the supply of generics;

Amendment 595 #

Andrey KOVATCHEV, Cristian-Silviu BUŞOI, Kateřina KONEČNÁ

Motion for a resolution
Paragraph 36

36. Calls on the Commission to analyse the causes of shortages, to establish and update together with Member States, EMA and relevant stakeholders a list of essential medicines under short of supply and monitor compliance with Article 81 of Directive 2001/83/EU on shortages of supply, and to promote the supply of generics;

Amendment 596 #

Motion for a resolution
Paragraph 36

36. Calls on the Commission to analyse the causes of shortages, to establish a list of essential medicines and monitor compliance with Article 81 of Directive 2001/83/EU on shortages of supply, and to promote the supply of generics after providing a cost-benefit report on the access on generic medicines;;

Amendment 597 #

Motion for a resolution
Paragraph 36

36. Calls on the Commission to analyse the causes of shortages, particularly the specific impact of parallel trade of medicines, to establish a list of essential medicines and monitor compliance with Article 81 of Directive 2001/83/EU on shortages of supply, and to promote the supply of generics;

Amendment 598 #

Motion for a resolution
Paragraph 36

36. Calls on the Commission to analyse the causes of shortages, to establish a list of essential medicines and monitor compliance with Article 81 of Directive 2001/83/EU on shortages of supply, and to take action to deal with these shortages and to promote the supply of generics;

Amendment 599 #

Karl-Heinz FLORENZ

Motion for a resolution
Paragraph 36

36. Calls on the Commission to analyse the causes of shortages, to ~~establish~~check the practicality and purpose of a list of essential medicines and monitor the Member States’ compliance with Article 81 of Directive 2001/83/EU on shortages of supply, and to promote the supply of generics;

Amendment 6 #

Motion for a resolution
Citation 2 a (new)

- having regard to the Communication from the Commission on inequalities in health published in 2013 in which it is recognised that health systems play an important role in reducing the risk of poverty or may help to reduce poverty,

Amendment 60 #

Mireille D'ORNANO, Jean-François JALKH, Sylvie GODDYN

Motion for a resolution
Recital B c (new)

Bc. whereas ensuring that patients have access to essential and affordable medicines is one of the core objectives of the EU and the WHO; and target of Millennium Development Goals

Amendment 600 #

Motion for a resolution
Paragraph 36

36. Calls on the Commission, by way of independent studies, to analyse the causes of shortages, to establish a list of essential medicines and monitor compliance with Article 81 of Directive 2001/83/EU on shortages of supply, and to promote the supply of generics;

Amendment 601 #

Motion for a resolution
Paragraph 36

36. Calls on the Commission to analyse the causes of shortages, to establish a list of essential medicines and ~~monitor compliance with~~submit a proposal to further specify Article 81 of Directive 2001/83/EU on shortages of supply, and to promote the supply of generic and biosimilar medicines;

Amendment 602 #

Motion for a resolution
Paragraph 36

Amendment 603 #

Motion for a resolution
Paragraph 36

Amendment 604 #

Cristian-Silviu BUŞOI, Mairead McGUINNESS

Motion for a resolution
Paragraph 36

Amendment 605 #

Motion for a resolution
Paragraph 36

36. Ccalls on the Commission to analyse the causes of shortages, toespecially due the impact of parallel trade, to address effectively parallel trade consequences by establishing a list of essential medicines and a mechanism to enable stable supply of these medicines and monitor compliance with Article 81 of Directive 2001/83/EU on shortages of supply, and to promote the supply of generics;

Amendment 606 #

Motion for a resolution
Paragraph 36

36. Calls on the Commission to analyse the causes of ~~shortag~~medicines, to establish a list of essential medicines and monitor compliance with Article 81 of Directive 2001/83/EU on shortages of supply, and to promote the supply of generics;

Amendment 607 #

Motion for a resolution
Paragraph 36 a (new)

36a. Calls on the European Commission to assess the impact of parallel trade in hampering access to treatments and creates significant shortages in certain Member States, in view of producing a legislative proposal to control and decrease the phenomenon of parallel trade;

Amendment 608 #

Elisabetta GARDINI, Giovanni LA VIA, Aldo PATRICIELLO, Alessandra MUSSOLINI

Motion for a resolution
Paragraph 36 a (new)

36a. Notes the fragmentation of systems within the EU is presently very high and leads to duplication of efforts and misallocation of resources within the EU for Member States and industry. The lack of predictability has also an adverse impact;

Amendment 609 #

Motion for a resolution
Paragraph 36 a (new)

36a. Calls on the European Commission to assess the impact of parallel trade in hampering access to treatments, in view of producing a legislative proposal to control and decrease the phenomenon of parallel trade;

Amendment 61 #

Motion for a resolution
Recital B d (new)

Bd. whereas unequal access to medicines is not a new phenomenon, reported for the developing countries by WHO, but the recent economic crisis has only exacerbated the problem in developed countries also;

Amendment 610 #

Motion for a resolution
Paragraph 36 a (new)

36a. Calls on the Commission to put forward, with wide stakeholder input, a set of clear definitions for medicines shortages and to enhance a policy dialogue on the topic;

Amendment 611 #

Motion for a resolution
Paragraph 36 a (new)

36a. Calls on the Commission to promote the importance of having the same medicine composition across the EU;

Amendment 612 #

Motion for a resolution
Paragraph 36 a (new)

36a. Calls on the Commission and Member States to develop a single eHealth and mHealth road map including notably the development and valorisation of pilots projects at national level, the modernisation of the reimbursement models stimulating a shift towards health outcomes driven healthcare systems, the definition of incentives to stimulate the healthcare community to engage in this digital revolution, and to enhance education of healthcare professionals, patients, and all relevant stakeholders to enable their empowerment;

Amendment 613 #

Cristian-Silviu BUŞOI, Mairead McGUINNESS, Andrey KOVATCHEV

Motion for a resolution
Paragraph 36 b (new)

36b. Calls to the Commission and Member States to coordinate a possible European joint procurement in the context of an European plan to eradicate hepatitis C;

Amendment 614 #

Motion for a resolution
Paragraph 36 b (new)

36b. Calls on the Commission and Council to establish a mechanism whereby medicine shortages across the EU can be reported upon on an annual basis;

Amendment 615 #

Cristian-Silviu BUŞOI, Mairead McGUINNESS, Andrey KOVATCHEV

Motion for a resolution
Paragraph 36 c (new)

36c. Calls on the Commission and Council to review the statutory basis of the European Medicines Agency, and give consideration to enhancing its remit to coordinate pan-European activity aiming at tackling medicines shortages in EU Member States;

Amendment 616 #

Motion for a resolution
Paragraph 36 b (new)

36b. Calls on the Commission to conduct an annual report on the status of medicines shortages across the EU;

Amendment 617 #

Motion for a resolution
Paragraph 37 a (new)

37a. Calls the urgency of the Threats of AMR recognised by the UN recently, call the commission to increases its actions to combat antimicrobial resistance and to present a new and comprehensive EU Action Plan based on the "One Health" approach, is crucial to include concert legislative on top on the three regulation;

Amendment 62 #

Motion for a resolution
Recital C

C. whereas ~~the prices of new medicines have increased during the past few decades to the point of being unaffordable for many European citizen~~pharmaceutical expenditure has remained constant, Member States are concerned with financing healthcare expenditures going forward given lower than expected economic growth, an ageing population and the high costs associated with treating patients with chronic diseases;

Amendment 63 #

Motion for a resolution
Recital C

C. whereas the p~~rices of new medicines have increased during the past few decades to the point of being unaffordable for many European citizen~~harmaceutical expenditures make Member States highly concerned about their long-run financing capability given the anaemic economic growth and the demographic pressures;

Amendment 64 #

Karl-Heinz FLORENZ, Peter LIESE, Andrey KOVATCHEV, Ivo BELET

Motion for a resolution
Recital C

C. whereas ~~the prices of new medicines~~, following the expiry of the patents on blockbuster medicines, the pharmaceutical sector changed its business model towards acquisitions of niche market pharmaceutical assets; whereas the prices of new medicines, directly linked to the need for pharmaceutical companies to propose an attractive return on investments for their shareholders, have increased during the past few decades to the point of being unaffordable for many European health care systems and citizens;

Amendment 65 #

Motion for a resolution
Recital C

C. whereas, in some cases, the prices of new medicines have increased during the past few decades to the point of ~~being unaffordable for many European citizen~~threatening the sustainability of national healthcare systems;

Amendment 66 #

Motion for a resolution
Recital C

C. whereas the prices of new medicines have increased during the past few decades to the point of being unaffordable for many European citizens and seriously affecting the sustainability of the national health care systems;

Amendment 67 #

Motion for a resolution
Recital C

C. whereas the prices of new medicines have increased during the past few decades to the point of being unaffordable for many European citizens; whereas manufacturers limit the volumes by imposing supply quotas which create imbalances on the market

Amendment 68 #

Motion for a resolution
Recital C

C. whereas the prices of new medicines have increased during the past few decades to the point of being unaffordable for many European citizens and particularly for citizens of the countries of southern Europe, such as Greece, Italy, Spain and Portugal;

Amendment 69 #

Motion for a resolution
Recital C

C. whereas the prices of new medicines have increased during the past few decades to the point of being unaffordable for many European health systems and citizens;

Amendment 7 #

Motion for a resolution
Citation 2 b (new)

- having regard to the conclusions of the Council on robust and sustainable health systems, reforms for sustainable health systems (efficiency, quality of innovation and prevention) of 2014,

Amendment 70 #

Alojz PETERLE

Motion for a resolution
Recital C a (new)

Ca. whereas the number of people diagnosed with cancer is rising every year and the combination of increased cancer incidence in the population and new technologically advanced cancer medicines results in a situation where the total cost of cancer is rising, which puts an unprecedented demand on healthcare budgets and makes treatment unaffordable for many cancer patients, thus leading to a risk that affordability or pricing of the medication will become a deciding factor in a patient's cancer treatment.

Amendment 71 #

Motion for a resolution
Recital C a (new)

Ca. whereas in 2014, outpatient pharmaceutical expenditure accounted for 17.1% of total health expenditure and for 1.41% of Gross Domestic Product (GDP) in the EU.

Amendment 72 #

Motion for a resolution
Recital D

D. whereas ~~in addition to high prices, other barriers to access to medicines include shortages~~ patient access to treatment is not only determined by the cost of medicines but by a variety of factors, including access to healthcare prof ess~~ential medicines, the poor connection between clinical needs and research, unjustified administrative procedures, rigid~~ionals and diagnostics, addressing healthcare system inefficiencies, clinical practice and the functioning of national pricing and reimbursement systems, measures aimed at improving patient ~~rules and budget restrictions~~access should address the determinants holistically;

Amendment 73 #

Motion for a resolution
Recital D

D. whereas in addition to high prices and unaffordability, other barriers to access to medicines include austerity policies and linear cuts to healthcare spending, shortages of essential medicines and inappropriate use, the poor connection between clinical needs and research, unjustified administrative procedures, rigid patent rules ~~and budget restriction~~, lack of sufficiently qualified and skilled healthcare workers;

Amendment 74 #

Frédérique RIES, Françoise GROSSETÊTE

Motion for a resolution
Recital D

D. whereas in addition to high prices, other barriers to access to medicines include shortages of essential medicines, the poor connection between clinical needs and research, unjustified administrative procedures, rigid patent rules and budget restrictions owing in particular to the economic crisis that has hit the European Union and austerity policies;

Amendment 76 #

Motion for a resolution
Recital D

D. whereas in addition to high prices, other barriers to access to medicines include shortages of essential medicines, the ~~poor connection between~~difficulty with always reconciling research and clinical needs ~~and research~~, unjustified administrative procedures~~, rigid patent rules and budget restrictions~~ and delays to marketing authorisation, patent rules which are sometimes too rigid and budget choices with regard to reimbursement;

Amendment 77 #

Motion for a resolution
Recital D

D. whereas in addition to high prices, other barriers to access to medicines include shortages of essential medicines, the poor connection between clinical needs and research, unjustified administrative procedures, rigid patent rules, inadequate funding by the EU for the health systems of its Member States and budget restrictions;

Amendment 78 #

Motion for a resolution
Recital D

D. whereas in addition to high prices, other barriers to access to medicines include shortages of essential medicines, the poor connection between clinical needs and research, reimbursement systems, access to healthcare professionals and diagnostics, unjustified administrative procedures, rigid patent rules and budget restrictions;

Amendment 79 #

Motion for a resolution
Recital D

D. whereas in addition to high prices, other barriers to access to medicines include shortages of essential medicines, the poor connection between clinical needs and research, unjustified administrative procedures, unavailability of products, rigid patent rules and budget restrictions;

Amendment 8 #

Motion for a resolution
Citation 3 a (new)

- having regard to the Commission Communication on Secure, Innovative and accessible medicines: a renovated view for the pharmaceutical sector (COM(2008)666)

Amendment 80 #

Alojz PETERLE

Motion for a resolution
Recital D

D. whereas in addition to high prices, other barriers to access to medicines include shortages of essential medicines, the poor connection between clinical needs and research, unjustified administrative procedures, unavailability of products, rigid patent rules and budget restrictions;

Amendment 81 #

Motion for a resolution
Recital D

Da. whereas the gradual ageing of the population will lead to an increase in healthcare costs and whereas the Member States will have to guarantee that a sufficient part of their budget is spent on the health and wellbeing of their citizens;

Amendment 83 #

José Inácio FARIA, Jasenko SELIMOVIC, Marian HARKIN, Jana TOOM

Motion for a resolution
Recital D a (new)

Da. whereas a stable and predictable intellectual property and regulatory framework, as well as the proper and timely implementation thereof are essential to create an innovation-friendly environment, supporting patient access to innovative and effective treatments;

Amendment 84 #

Motion for a resolution
Recital D a (new)

Da. whereas the growing expenditure in the pharmaceutical sector prompts European cooperation and new policy measures at both EU and national level to enable selective investment in efficient and effective healthcare;

Amendment 85 #

Françoise GROSSETÊTE, Frédérique RIES, Cristian-Silviu BUŞOI

Motion for a resolution
Recital D a (new)

E. whereas the ~~aim of~~system for protecting intellectual property is ~~to benefit society, gua~~all too often used to generante~~eing investment returns to promote innovation, and whereas there is concern about the abuse/misuse thereof~~ economic benefits for pharmaceutical companies beyond lawful profit margins instead of according to the needs of patients, resulting in an irreconcilable conflict with the fundamental right to health;

Amendment 87 #

Frédérique RIES

Motion for a resolution
Recital E

E. whereas the aim of intellectual property is to benefit society, guaranteeing investment returns to promote innovation, ~~and whereas there is concern about the abuse/misuse thereof~~particularly considering that patent law contributes to the innovation cycle of medicines, even if there is concern about the granting of unoriginal or excessively broad patents;

Amendment 88 #

Andrey KOVATCHEV, Cristian-Silviu BUŞOI, Kateřina KONEČNÁ, Karl-Heinz FLORENZ, Karin KADENBACH

Motion for a resolution
Recital E

E. whereas the aim of intellectual property is to benefit society~~, guaranteeing investment returns to~~ and promote innovation, and whereas there is concern about the abuse/misuse thereof; notes the Council Conclusions of 17 June 2016 inviting the Commission to conduct an evidence-based analysis on the overall impact of IP in promoting innovation;

Amendment 89 #

José Inácio FARIA, Jasenko SELIMOVIC, Anneli JÄÄTTEENMÄKI, Marian HARKIN, Lieve WIERINCK

Motion for a resolution
Recital E

E. whereas the aim of intellectual property is to benefit society, guaranteeing investment returns to promote innovation, and ~~whereas there is concern~~accessibility of the knowledge contained in patent applications, whereas the WTO Doha declaration on the TRIPS agreement and Public Health raised concerns about its effects on prices and whereas the Commission raised concerns in its sector inquiry about the abuse/misuse thereof;

Amendment 9 #

Motion for a resolution
Citation 3 a (new)

- having regard to the Report of the United Nations Secretary-General's High- Level Panel on Access to Medicines

Amendment 90 #

Lieve WIERINCK, Gesine MEISSNER, Anneli JÄÄTTEENMÄKI, Marian HARKIN, Jana TOOM, Jasenko SELIMOVIC

Motion for a resolution
Recital E

E. whereas the aim of intellectual property is to benefit society, guaranteeing investment returns to promote innovation, and whereas there is concern about the abuse/misuse thereof; whereas patent extensions or additional certificates may protect modifications without much added value, a better option than incentivising the pursuit of truly innovative new treatments and medicines;

Amendment 91 #

Motion for a resolution
Recital E

E. whereas the aim of intellectual property is to benefit society, guaranteeing investment returns to promote innovation, and ~~whereas there is concern about the abuse/misuse thereof~~to diffuse knowledge;

Amendment 92 #

José Inácio FARIA, Jasenko SELIMOVIC, Marian HARKIN, Jana TOOM

Motion for a resolution
Recital E

E. whereas the aim of intellectual property is to benefit society, ~~guaranteeing~~ incentivise investment ~~return~~s to promote innovation, and whereas there is concern about the abuse/misuse thereof;

Amendment 93 #

Motion for a resolution
Recital E

E. whereas the aim of intellectual property is to ~~benefit society,~~ guarantee~~ing~~ investment returns to promote innovation, and whereas there isare concerns about the abuse/misuse thereof;

Amendment 94 #

Motion for a resolution
Recital E a (new)

Ea. whereas research on rare diseases is more challenging due to their complexity and difficulties in recruitment for clinical trials due to a limited number of patients, therefore requiring incentives for manufacturers to take the risk of investing in this area;

Amendment 95 #

Motion for a resolution
Recital E a (new)

Ea. whereas significant progress has been made in recent decades as regards treating previously incurable diseases, meaning, for example, that no more patients die of HIV/AIDS in the EU today; however, there are still many diseases against which there is no optimal treatment (including cancer, which kills almost 1.3 million individuals in the EU every year);

Amendment 96 #

Motion for a resolution
Recital E a (new)

Ea. whereas several years ago, a high- level European dialogue (the ‘G10’ between 2001 and 2002 then the Pharmaceutical Forum between 2005 and 2008) which brought together the key decision-makers and stakeholders in the health world decided to develop a shared strategic vision and to take specific steps to help with the competitiveness of the pharmaceutical sector;

Amendment 97 #