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 #

Piernicola PEDICINI, Eleonora EVI, Marco AFFRONTE

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 #

Piernicola PEDICINI, Eleonora EVI, Marco AFFRONTE

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 #

Francisco de Paula GAMBUS MILLET

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 #

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 #

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

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 #

Francisco de Paula GAMBUS MILLET

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 #

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 #

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

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 #

José Inácio FARIA

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 #

Peter LIESE, Karl-Heinz FLORENZ

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 #

György HÖLVÉNYI, Alojz PETERLE

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 #

Damiano ZOFFOLI, Soledad CABEZÓN RUIZ

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 #

José Inácio FARIA

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 #

Cristian-Silviu BUŞOI, Andrey KOVATCHEV

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 #

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 #

Frédérique RIES, Françoise GROSSETÊTE

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 #

Nikolay BAREKOV, Bolesław G. PIECHA

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 #

Nicola CAPUTO, Marc TARABELLA

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 #

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

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 #

Françoise GROSSETÊTE, Angélique DELAHAYE

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 #

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

Motion for a resolution
Citation 5 a (new)

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

Amendment 180 #

Eva KAILI

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 #

Annie SCHREIJER-PIERIK

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 #

Daciana Octavia SÂRBU

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 #

György HÖLVÉNYI

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 #

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

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 #

Damiano ZOFFOLI, Soledad CABEZÓN RUIZ

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 #

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

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 #

Annie SCHREIJER-PIERIK

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 #

Krzysztof HETMAN

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 #