Activities of José Inácio FARIA related to 2016/2057(INI)
Shadow reports (1)
REPORT on EU options for improving access to medicines PDF (447 KB) DOC (95 KB)
Amendments (64)
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 11 #
Motion for a resolution
Citation 4
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 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 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 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 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 131 #
Motion for a resolution
Recital I
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 143 #
Motion for a resolution
Recital J a (new)
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 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 160 #
Motion for a resolution
Paragraph 1 a (new)
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 167 #
Motion for a resolution
Paragraph 2
Paragraph 2
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 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 210 #
Motion for a resolution
Paragraph 4 a (new)
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 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 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 273 #
Motion for a resolution
Paragraph 9 e (new)
Paragraph 9 e (new)
9e. Highlights that value-based pricing of medicines can be misused as a profit- maximization economic strategy, which in that case leads to the setting of prices that are disproportionate to its cost structure, regardless of an optimal distribution of social welfare
Amendment 274 #
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 284 #
Motion for a resolution
Paragraph 10 c (new)
Paragraph 10 c (new)
10c. Notes that more dynamic pricing models such as outcomes-based pricing or managed entry agreements for innovative medicines, that imply conditional reimbursement and flexible pricing, require a solid evidence basis; highlights the difficulty of collecting both patient- relevant data and healthcare resource utilization data in real healthcare settings; stresses the need for stakeholder involvement and collaborative efforts between Member States and the Commission to step up advancement in the infrastructure necessary to capture outcomes data, through registries and interoperable electronic patient records, e- health and big data analysis, in respect of data privacy;
Amendment 285 #
Motion for a resolution
Paragraph 10 d (new)
Paragraph 10 d (new)
10d. Underlines in this context, the need for independent processes of data collection and analysis and for transparency;
Amendment 286 #
Motion for a resolution
Paragraph 10 e (new)
Paragraph 10 e (new)
10e. Acknowledges the advantages of using adaptive licensing of new medicines to lower development costs and promote faster patient access; Underlines that a higher degree of uncertainty regarding the safety and effectiveness of a new medicine at the point of entry into the market is inherent to adaptive licensing in comparison with traditional licensing; Recognises the persistence of deficiencies in the current implementation of post- marketing surveillance system; Believes that adaptive licensing should be restricted to specific cases of high unmet medical need and calls the European Commission and the European Medicines Agency to put in place guidelines in order to ensure patient safety; Acknowledges the potential of adaptive pathways for adaptive pricing decision of new medicines, once patient safety is adequately ensured;
Amendment 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 296 #
Motion for a resolution
Paragraph 12 a (new)
Paragraph 12 a (new)
12a. Highlights that current pricing systems such as international reference pricing limits access to innovative medicines in EU countries with comparatively lower GDP per capita; notes with concern that due to the lower negotiating power of small and lower income countries, medicines are comparatively less affordable in such Member States, namely in the oncology area; Regrets, in the context of international reference pricing, the lack of transparency in list prices of medicines as compared to actual prices and the information asymmetry that it brings to negotiations between industry and national health systems;
Amendment 302 #
Motion for a resolution
Paragraph 12 b (new)
Paragraph 12 b (new)
12b. Highlights that international reference pricing is a driver of delayed market entry for innovative medicines in lower income Member States and of medicines shortages through parallel trade; Invites Member States and the Commission to promote closer cooperation towards a voluntary agreement on a differential pricing system that should reflect factors such as differences in income per capita, and which could enhance overall welfare;
Amendment 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 348 #
Motion for a resolution
Paragraph 16
Paragraph 16
16. Highlights the European procedure for joint procurement of medicines used for the acquisition of vaccines in accordance with Decision No 1082/2013/EU; encourages Members States to make full use of this tool;
Amendment 355 #
Motion for a resolution
Paragraph 16 a (new)
Paragraph 16 a (new)
16a. Notes with concern that the EU lags behind the USA in what regards a standardized and transparent reporting mechanism on the causes of medicines shortages; invites the Commission and Member States to propose and put in place such an instrument for evidence- based policy-making;
Amendment 361 #
Motion for a resolution
Paragraph 16 b (new)
Paragraph 16 b (new)
16b. Highlights the role of the European Union in monitoring and providing guidance on economic policies within the framework of the European Semester, and welcomes the adoption of country-specific recommendations in the area of healthcare systems sustainability;
Amendment 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 403 #
Motion for a resolution
Paragraph 19 a (new)
Paragraph 19 a (new)
19a. Highlights the threat of growing antimicrobial resistance; calls on the Commission to put forward measures to promote R&D in the public and the private sector and to build a business case to incentivise the development and commercialisation of antibiotics of last resource to fight the lack of innovation in this area;
Amendment 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 423 #
Motion for a resolution
Paragraph 20 b (new)
Paragraph 20 b (new)
20b. Recognises that off-label use of medicines can bring benefits to patients when approved alternatives are absent; Notes with concern that patients are subject to increased risks due to the lack of a solid evidence-base proving safety and efficacy of off-label use, to the lack of informed consent and to increased difficulty in monitoring adverse events; underlines that certain population sub- groups are particularly exposed to this practice such as children and the elderly;
Amendment 424 #
Motion for a resolution
Paragraph 20 c (new)
Paragraph 20 c (new)
20c. Calls on the Commission, the European Medicines Agency and Member States to promote Good Off-Label Use Guidelines in order to reduce patients' risk associated with this clinical practice; Calls on the Commission to analyse the drivers of off-label use and to propose measures that mitigate the need for this clinical practice, by promoting access to all patients' groups to licensed indications, for example through adequate incentives for drug repurposing and new indication licensing;
Amendment 425 #
Motion for a resolution
Paragraph 20 d (new)
Paragraph 20 d (new)
20d. Calls on the Commission to collaborate with the European Medicines Agency and with stakeholders with a view to introduce a Code of Practice for mandatory reporting of adverse events and of outcomes for off-label use of medicines and to ensure patients' registries in order to strengthen the evidence base and mitigate risks for patients;
Amendment 426 #
Motion for a resolution
Paragraph 20 e (new)
Paragraph 20 e (new)
20e. Acknowledges the significant development of medicinal products with the orphan designation following the incentives put in place by the current legislative framework on orphan medicinal products; notes that such medicines are also used off-label, or repurposed and authorised for additional indications allowing increased sales and returns; calls on the Commission to examine these occurrences and to monitor the volume of sales of such medicines to ensure balanced incentives without discouraging innovation in this area;
Amendment 427 #
Motion for a resolution
Paragraph 20 f (new)
Paragraph 20 f (new)
20f. Notes that the repurposing of existing drugs for new indications can be accompanied by a price increase; asks the Commission to collect and analyse data on price increases in cases of drug repurposing and to report back to the European Parliament and the Council on the balance and proportionality of the incentives that encourage industry to invest in drug repurposing;
Amendment 428 #
Motion for a resolution
Paragraph 20 g (new)
Paragraph 20 g (new)
20g. Recognises the need to ensure the continued supply of medicines with proven added value for patients and health systems; Calls on the Commission to monitor and to propose measures, when appropriate, on the withdrawal of old molecules from the market for commercial reasons, including its re- authorisation for a new indication at a much higher price;
Amendment 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 519 #
Motion for a resolution
Paragraph 27
Paragraph 27
27. Calls on the Council toand the Commission to promote increased cooperation between the Member States as regards price-setting procedures, in order to share information about prices, reimbursement, negotiation agreements and good practices and to avoid unnecessary administrative requirements and delays;
Amendment 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 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 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 587 #
Motion for a resolution
Paragraph 35
Paragraph 35
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;