60 Amendments of Marian HARKIN related to 2016/2057(INI)
Amendment 3 #
Draft opinion
Recital A
Recital A
A. whereas guaranteeing universal access to medicines presents a myriad ofany challenges but nonetheless must be our common goal;
Amendment 8 #
Draft opinion
Recital B
Recital B
Amendment 9 #
Motion for a resolution
Citation 3 a (new)
Citation 3 a (new)
- having regard to the Report of the United Nations Secretary-General's High- Level Panel on Access to Medicines
Amendment 15 #
Draft opinion
Recital C
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 44 #
Draft opinion
Paragraph 3
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 fundingBelieves 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 47 #
Motion for a resolution
Recital B a (new)
Recital B a (new)
Ba. whereas the high prices of innovative medicines conflicts with the patients' and national health systems' ability to pay for pharmaceutical expenditure and hinders the fundamental right of citizens to health and medical treatment;
Amendment 51 #
Draft opinion
Paragraph 3 a (new)
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 78 #
Draft opinion
Paragraph 7
Paragraph 7
Amendment 84 #
Draft opinion
Paragraph 7 a (new)
Paragraph 7 a (new)
7a. Calls on the Commission to find solutions to bring unprofitable but medically necessary drugs in to production;
Amendment 84 #
Motion for a resolution
Recital D a (new)
Recital D a (new)
Da. whereas the growing expenditure in the pharmaceutical sector prompts European cooperation and new policy measures at both EU and national level to enable selective investment in efficient and effective healthcare;
Amendment 85 #
Draft opinion
Paragraph 7 b (new)
Paragraph 7 b (new)
7b. Calls on the Commission to increase research for neglected diseases;
Amendment 91 #
Motion for a resolution
Recital E
Recital E
E. whereas the aim of intellectual property is to benefit society, guaranteeing investment returns to promote innovation, and whereas there is concern about the abuse/misuse thereofto diffuse knowledge;
Amendment 92 #
Motion for a resolution
Recital E
Recital E
E. whereas the aim of intellectual property is to benefit society, guaranteeing incentivise investment returns to promote innovation, and whereas there is concern about the abuse/misuse thereof;
Amendment 111 #
Motion for a resolution
Recital F
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 122 #
Motion for a resolution
Recital G
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 124 #
Motion for a resolution
Recital G a (new)
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 130 #
Motion for a resolution
Recital I
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 entrycontributes to ensuring the sustainability of healthcare systems, and whereas market entry of generics and biosimilars should not be delayed;
Amendment 159 #
Motion for a resolution
Paragraph 1
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 177 #
Motion for a resolution
Paragraph 2 a (new)
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 185 #
Motion for a resolution
Paragraph 2 b (new)
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 #
Motion for a resolution
Paragraph 2 c (new)
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 #
Motion for a resolution
Paragraph 2 d (new)
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 #
Motion for a resolution
Paragraph 3
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 198 #
Motion for a resolution
Paragraph 3 a (new)
Paragraph 3 a (new)
3a. Recalls that robust clinical trials are necessary to assess the efficacy and safety of medicines;
Amendment 204 #
Motion for a resolution
Paragraph 4
Paragraph 4
4. Stresses that it is in the interests of the pharmaceutical industry favour short trials andand patients to ensure fast access to the market for innovative medicines both in-patent and off-patent;
Amendment 212 #
Motion for a resolution
Paragraph 4 a (new)
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 215 #
Motion for a resolution
Paragraph 4 b (new)
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 221 #
Motion for a resolution
Paragraph 4 c (new)
Paragraph 4 c (new)
4c. Considers innovation in the pharmaceutical sector to be crucial in order to address unmet medical needs;
Amendment 225 #
Motion for a resolution
Paragraph 5
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 230 #
Motion for a resolution
Paragraph 5 a (new)
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 234 #
Motion for a resolution
Paragraph 6
Paragraph 6
6. Emphasises that most medicines are not examples of genuine innovation, but often ‘me-too’ or ‘evergRecalls that incremental innovation for patented molecules such as repurposing, reformulation and the development of new medicines for the same indication ("me-too" substances) may offer incremening’ products, whictal value to patients, to patients sub-groups and to health care permitted notably by complementary patent extensionsystems; believes that the added value of such medicines should be carefully assessed and measurable benefits should be demonstrated prior to price and reimbursement decisions; warns against the potential misuse of IP protection rules allowing for the "evergreening" of patent rights;
Amendment 240 #
Motion for a resolution
Paragraph 6 a (new)
Paragraph 6 a (new)
6a. Recognises that medical innovation is also coming from known off-patent molecules through finding new indications, drug reformulations or new innovative combinations and stresses the importance to deliver to patients more customized treatments delivering better efficacy, less side effects, better adherence and better quality of life, to avoid disease exacerbations and costly therapeutic escalations;
Amendment 263 #
Motion for a resolution
Paragraph 9
Paragraph 9
9. Stresses that better regulation will promote competitiveness; also recognises the importance and effectiveness of antitrust tools against anti-competitive behaviours such as the abuse or misuse of patent systems and of the system for authorisation of medicines, in violation of Articles 101 and/or 102 of the TFEU; calls on the Commission to carry out an in- depth analysis of the existing Intellectual Property legislation in the pharmaceutical sector with a focus on divergent interpretation and litigation cases and, where necessary, to bring forward a legislative review to ascertain legal clarity and the correct implementation and use of legal provisions in order to safeguard legitimate intellectual property and patent rights, as well as public interest;
Amendment 264 #
Motion for a resolution
Paragraph 9 a (new)
Paragraph 9 a (new)
9a. Calls on the Commission to revise the Transparency Directive with a focus on guaranteeing timely entry into the market for generic and biosimilar medicines, ending patent linkage according to Commission's guidelines, accelerating pricing and reimbursement decisions for generics and precluding the multiple reassessment of the elements supporting marketing authorisation; Believes that this will maximise savings for national health budgets, improve affordability, accelerate patient access and prevent administrative burdens for generic and biosimilar companies;
Amendment 269 #
Motion for a resolution
Paragraph 9 b (new)
Paragraph 9 b (new)
9b. Calls on the Commission to monitor regularly patent settlement agreements that may restrict generic market entry into the market in exchange for benefits transferred from the originator to the generic company;
Amendment 270 #
Motion for a resolution
Paragraph 9 c (new)
Paragraph 9 c (new)
9c. Calls on the Commission to introduce a Supplementary Protection Certificate (SPC) manufacturing waiver to Regulation 469/2009 allowing the production of generic and biosimilar medicines in Europe, with the purpose of exporting them to countries without SPCs or where these have expired earlier, without undermining the exclusivity granted under the SPC regime in protected markets; believes that such provisions could have a positive impact on access to high quality medicines in developing and least developed countries and on increasing manufacturing and R&D in Europe, creating new jobs and stimulating economic growth;
Amendment 272 #
Motion for a resolution
Paragraph 9 d (new)
Paragraph 9 d (new)
9d. Highlights that some Member States have achieved particularly low prices by the use of large-scale tendering in generic medicines; Notes with concern that excessive focus on short-term cost- savings may lead to medium- and long- term unintended consequences such as market concentration in the generic industry, and increased risk of shortages due to lack of redundancy in the system and lack of financial motivation to produce low-profit margin medicines, as well as low-volume drugs;
Amendment 274 #
Motion for a resolution
Paragraph 9 f (new)
Paragraph 9 f (new)
9f. Considers that pricing and reimbursement decisions need to consider the added value of innovative medicines while avoiding unilateral appropriation of such value; stresses that new and fairer pricing models should aim at shared and balanced stakeholder benefit, by ensuring payers' sustainability, patients' health gains and proportionate industry profits;
Amendment 280 #
Motion for a resolution
Paragraph 10 a (new)
Paragraph 10 a (new)
10a. Notes with concern that data supporting the assessment of the added value of innovative medicines is often scarce and not sufficiently convincing to support solid decision making on pricing;
Amendment 283 #
Motion for a resolution
Paragraph 10 b (new)
Paragraph 10 b (new)
10b. Considers that independent and good quality evidence is crucial to determine the cost-effectiveness of new medicines;
Amendment 288 #
Motion for a resolution
Paragraph 11 a (new)
Paragraph 11 a (new)
11a. Highlights the technical nature of Relative Efficacy and Effectiveness Assessment (REA) and of Therapeutic Added Value (ATV) procedures; Notes that differences in methodological approaches and quality of evidence required at Member State level contribute to unnecessary fragmentation and increased burden for industry;
Amendment 291 #
Motion for a resolution
Paragraph 11 b (new)
Paragraph 11 b (new)
11b. Calls on Member States and the Commission to pursue efforts to develop shared capacities, data and methodologies; Calls on the Commission to put forward a proposal for a common framework for REA and ATV to be carried out at European level, with the participation of expert representatives from Member States; Believes this should be done within the existing institutional context and in respect of national competences concerning social and economic considerations within pricing and reimbursement decisions;
Amendment 310 #
Motion for a resolution
Paragraph 13
Paragraph 13
13. Believes that a fair price should coverfor a medicine delivering additional benefit to patients should take into account the cost of the drug development and production, plus a margin of profit;
Amendment 321 #
Motion for a resolution
Paragraph 13 a (new)
Paragraph 13 a (new)
13a. Stresses the importance of transparency, including as regards clinical data, R&D costs and public funding, marketing strategies, actual prices and reimbursement levels, to improve access to medicines with relevant additional benefits for patient and health systems;
Amendment 324 #
Motion for a resolution
Paragraph 13 b (new)
Paragraph 13 b (new)
13b. Encourages Members States to engage in early dialogue and horizon scanning with industry, patients and payers and to anticipatorily incorporate in their determination of the cost- effectiveness of new medicines the forecasted evolution in the pharmaceutical innovation pipeline while giving due regard to budgetary impact considerations;
Amendment 350 #
Motion for a resolution
Paragraph 16
Paragraph 16
16. Highlights the European procedure for joint procurement of medicines used for the acquisition of vaccineal countermeasures for serious cross border health threats in accordance with Decision No 1082/2013/EU;
Amendment 389 #
Motion for a resolution
Paragraph 18
Paragraph 18
18. Calls for EU-wide measures on the pharmaceutical market to reinforce the negotiation capacities of Member States in order to achieve fair prices for medicines, such as the initiative of the Benelux countries and Austria on rare diseases;
Amendment 420 #
Motion for a resolution
Paragraph 20 a (new)
Paragraph 20 a (new)
20a. Acknowledges that the incentives put forward by the Paediatric Regulation have not proved effective to drive innovation in medicines for children, namely in the fields of oncology and neonatology; calls on the Commission to examine existing obstacles and propose measures to promote advancement in this area;
Amendment 426 #
Motion for a resolution
Paragraph 20 e (new)
Paragraph 20 e (new)
20e. Acknowledges the significant development of medicinal products with the orphan designation following the incentives put in place by the current legislative framework on orphan medicinal products; notes that such medicines are also used off-label, or repurposed and authorised for additional indications allowing increased sales and returns; calls on the Commission to examine these occurrences and to monitor the volume of sales of such medicines to ensure balanced incentives without discouraging innovation in this area;
Amendment 446 #
Motion for a resolution
Paragraph 22
Paragraph 22
22. Calls on the Commission to review aluate the regulatory framework for orphan medicines, to define clearly the concept of unmet medical needs, to assess the impact of incentives to develop effective, safe and affordable drugs compared to the best available alternative and to promote the European register of rare diseases and reference centres;
Amendment 460 #
Motion for a resolution
Paragraph 23
Paragraph 23
23. Calls on the Commission to guarantee safety and efficacy in any fast- track approval process and to introduce the concept of conditional authorisation based on effectivenessensure that such approvals are admissible in exceptional circumstances where a high unmet medical need has been identified;
Amendment 480 #
Motion for a resolution
Paragraph 24
Paragraph 24
24. Calls on the Commission to set up a framework to promote, guarantee and reinforce the competitiveness of generic and biosimilar medicines, guaranteeing their faster entry onto the market and monitoring unfair practices in accordance with Articles 101 and 102 of the TFEU, and to present a biannual report in this regard;
Amendment 521 #
Motion for a resolution
Paragraph 27
Paragraph 27
27. Calls on the Council to increase cooperation between the Member States as regards price-setting procedures, in order to share information about prices, reimbursement, negotiation agreements and good practices and to avoid unnecessary administrative requirements and delays, ensuring faster patient access to innovative medicines;
Amendment 534 #
Motion for a resolution
Paragraph 28
Paragraph 28
28. Calls on the Council to promote rational use of medicines across the EU, such as avoiding overconsumption of medicines, in particular antibiotics;
Amendment 538 #
Motion for a resolution
Paragraph 28 a (new)
Paragraph 28 a (new)
28a. Call on the Member States to ensure accessibility of pharmacies, including their density in both urban and rural areas, professional staff number, appropriate opening hours, qualitative advice and counselling service;
Amendment 540 #
Motion for a resolution
Paragraph 28 a (new)
Paragraph 28 a (new)
28a. Calls on the Commission and on Member States to ensure full implementation of the pharmacovigilance legislation;
Amendment 541 #
Motion for a resolution
Paragraph 28 b (new)
Paragraph 28 b (new)
28b. Call on the Member States to ensure that for the protection of health and life and in the interests of consumer protection information notes accompanying medicines are provided by retailers in widely used languages of a particular Member State in addition to official language or languages;
Amendment 551 #
Motion for a resolution
Paragraph 29 a (new)
Paragraph 29 a (new)
29a. Calls on the Member States to enter into dialogue with all the relevant stakeholders, such as patient organisations, paying agencies, healthcare professionals and industry, with the aim of establishing short-, medium- and long term holistic strategies for access to medicines, ensuring the sustainability of healthcare systems and a competitive pharmaceutical industry, leading to faster access for patients and affordable prices;
Amendment 578 #
Motion for a resolution
Paragraph 34
Paragraph 34
34. Calls on the Commission to examine and compare the actual prices of medicines in the EU and to present an annual report to the Council and to the European Parliament in this regard;
Amendment 592 #
Motion for a resolution
Paragraph 36
Paragraph 36
36. Calls on the Commission to analyse the causes of shortages, to establish a list of essential medicines and monitor compliance with Article 81 of Directive 2001/83/EU on shortages of supply, to explore mechanisms to address the withdrawal of effective medicines from the market purely for commercial reasons, such as remarketing for new indications, and to promote the supply of generics;