Activities of Soledad CABEZÓN RUIZ related to 2016/2057(INI)

Motion for a resolution
Citation 2 a (new)

- having regard to the Communication from the Commission on inequalities in health published in 2013 in which it is recognised that health systems play an important role in reducing the risk of poverty or may help to reduce poverty,

2016/10/21
Committee: ENVI

Motion for a resolution
Citation 2 b (new)

- having regard to the conclusions of the Council on robust and sustainable health systems, reforms for sustainable health systems (efficiency, quality of innovation and prevention) of 2014,

2016/10/21
Committee: ENVI

Motion for a resolution
Citation 3 a (new)

- having regard to the Commission Communication on Secure, Innovative and accessible medicines: a renovated view for the pharmaceutical sector (COM(2008)666)

2016/10/21
Committee: ENVI

Motion for a resolution
Citation 3 b (new)

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

2016/10/21
Committee: ENVI

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;

2016/07/25
Committee: PETI

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;

2016/07/25
Committee: PETI

Motion for a resolution
Citation 5 a (new)

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

2016/10/21
Committee: ENVI

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

2016/10/21
Committee: ENVI

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))

2016/10/21
Committee: ENVI

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

2016/10/21
Committee: ENVI

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

2016/10/21
Committee: ENVI

Motion for a resolution
Citation 5 f (new)

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

2016/10/21
Committee: ENVI

Motion for a resolution
Citation 5 g (new)

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

2016/10/21
Committee: ENVI

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;

2016/07/25
Committee: PETI

Motion for a resolution
Citation 5 h (new)

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

2016/10/21
Committee: ENVI

Motion for a resolution
Citation 5 i (new)

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

2016/10/21
Committee: ENVI

Motion for a resolution
Citation 5 j (new)

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

2016/10/21
Committee: ENVI

Motion for a resolution
Citation 5 k (new)

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

2016/10/21
Committee: ENVI

Motion for a resolution
Citation 5 l (new)

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

2016/10/21
Committee: ENVI

Motion for a resolution
Citation 6 a (new)

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

2016/10/21
Committee: ENVI

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;

2016/07/25
Committee: PETI

Motion for a resolution
Recital A a (new)

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

2016/10/21
Committee: ENVI

Motion for a resolution
Recital B a (new)

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

2016/10/21
Committee: ENVI

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;

2016/07/25
Committee: PETI

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;

2016/07/25
Committee: PETI

Motion for a resolution
Recital B a (new)

Ba. whereas insufficient access to essential medicinal products poses a serious threat to the well-being

2016/10/21
Committee: ENVI

Motion for a resolution
Recital B b (new)

Bb. whereas with a 20% return on investment, the pharmaceutical sector is one of the EU’s most competitive, but it also creates 800 000 jobs and turns over EUR 200 billion per year; whereas the sector is facing up to important competitors such as the United States and the Asian market, and as a result strategies need to be put in place to enable it to become more competitive, for which quality of innovation may be key;

2016/10/21
Committee: ENVI

Motion for a resolution
Recital B b (new)

Bb. whereas general concern exists in the society and authorities on access to medicines in Europe and on sustainability of health system

2016/10/21
Committee: ENVI

Motion for a resolution
Recital B c (new)

Bc. having regard to the conclusions of the Council on robust and sustainable health systems, and reforms for sustainable health systems (efficiency, quality of innovation and prevention) of 2014,

2016/10/21
Committee: ENVI

Motion for a resolution
Recital B c (new)

Bc. whereas ensuring that patients have access to essential and affordable medicines is one of the core objectives of the EU and the WHO; and target of Millennium Development Goals

2016/10/21
Committee: ENVI

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;

2016/07/25
Committee: PETI

Motion for a resolution
Recital B d (new)

Bd. whereas unequal access to medicines is not a new phenomenon, reported for the developing countries by WHO, but the recent economic crisis has only exacerbated the problem in developed countries also;

2016/10/21
Committee: ENVI

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;

2016/07/25
Committee: PETI

Demetris PAPADAKIS, Soledad CABEZÓN RUIZ, Jude KIRTON-DARLING

Motion for a resolution
Recital C

C. whereas the prices of new medicines have increased during the past few decades to the point of being unaffordable for many European health systems and citizens;

2016/10/21
Committee: ENVI

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.

2016/07/25
Committee: PETI

Motion for a resolution
Recital C a (new)

Ca. whereas in 2014, outpatient pharmaceutical expenditure accounted for 17.1% of total health expenditure and for 1.41% of Gross Domestic Product (GDP) in the EU.

2016/10/21
Committee: ENVI

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;

2016/07/25
Committee: PETI

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;

2016/07/25
Committee: PETI

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;

2016/07/25
Committee: PETI

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;

2016/07/25
Committee: PETI

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;

2016/07/25
Committee: PETI

Motion for a resolution
Recital E

E. whereas the aim of intellectual property is to benefit society, guaranteeing investment returns to promote innovation, and whereas there is concern about the abuse/misuse thereof; whereas patent extensions or additional certificates may protect modifications without much added value, a better option than incentivising the pursuit of truly innovative new treatments and medicines;

2016/10/21
Committee: ENVI

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.

2016/07/25
Committee: PETI

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;

2016/10/21
Committee: ENVI

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;

2016/10/21
Committee: ENVI

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;

2016/10/21
Committee: ENVI

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;

2016/10/21
Committee: ENVI

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;

2016/10/21
Committee: ENVI

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;

2016/10/21
Committee: ENVI

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)

2016/10/21
Committee: ENVI

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;

2016/10/21
Committee: ENVI

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

2016/10/21
Committee: ENVI

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;

2016/10/21
Committee: ENVI

Motion for a resolution
Paragraph 2 a (new)

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

2016/10/21
Committee: ENVI

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;

2016/10/21
Committee: ENVI

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;

2016/10/21
Committee: ENVI

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;

2016/10/21
Committee: ENVI

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;

2016/10/21
Committee: ENVI

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.

2016/10/21
Committee: ENVI

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

2016/10/21
Committee: ENVI

Motion for a resolution
Paragraph 6

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

2016/10/21
Committee: ENVI

Motion for a resolution
Paragraph 7 a (new)

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

2016/10/21
Committee: ENVI

Motion for a resolution
Paragraph 8

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

2016/10/21
Committee: ENVI

Motion for a resolution
Paragraph 9 a (new)

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

2016/10/21
Committee: ENVI

Motion for a resolution
Paragraph 10

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

2016/10/21
Committee: ENVI

Motion for a resolution
Paragraph 11 a (new)

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

2016/10/21
Committee: ENVI

Motion for a resolution
Paragraph 11 b (new)

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

2016/10/21
Committee: ENVI

Motion for a resolution
Paragraph 11 c (new)

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

2016/10/21
Committee: ENVI

Motion for a resolution
Paragraph 11 d (new)

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

2016/10/21
Committee: ENVI

Motion for a resolution
Paragraph 11 e (new)

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

2016/10/21
Committee: ENVI

Nicola CAPUTO, Soledad CABEZÓN RUIZ

Motion for a resolution
Paragraph 12 a (new)

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

2016/10/21
Committee: ENVI

Motion for a resolution
Paragraph 13

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

2016/10/21
Committee: ENVI

Motion for a resolution
Paragraph 13

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

2016/10/21
Committee: ENVI

Motion for a resolution
Paragraph 13

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

2016/10/21
Committee: ENVI

Motion for a resolution
Paragraph 13 a (new)

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

2016/10/21
Committee: ENVI

Motion for a resolution
Paragraph 13 a (new)

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

2016/10/21
Committee: ENVI

Motion for a resolution
Paragraph 13 b (new)

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

2016/10/21
Committee: ENVI

Motion for a resolution
Paragraph 13 c (new)

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

2016/10/21
Committee: ENVI

Motion for a resolution
Paragraph 13 d (new)

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

2016/10/21
Committee: ENVI

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

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

2016/10/21
Committee: ENVI

Motion for a resolution
Paragraph 14 a (new)

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

2016/10/21
Committee: ENVI

Motion for a resolution
Paragraph 14 b (new)

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

2016/10/21
Committee: ENVI

Motion for a resolution
Paragraph 16 a (new)

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

2016/10/21
Committee: ENVI

Motion for a resolution
Paragraph 16 a (new)

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

2016/10/21
Committee: ENVI

Motion for a resolution
Paragraph 16 b (new)

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

2016/10/21
Committee: ENVI

Motion for a resolution
Paragraph 16 b (new)

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

2016/10/21
Committee: ENVI

Motion for a resolution
Paragraph 17

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

2016/10/21
Committee: ENVI

Motion for a resolution
Paragraph 17

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

2016/10/21
Committee: ENVI

Motion for a resolution
Paragraph 18

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

2016/10/21
Committee: ENVI

Motion for a resolution
Paragraph 19

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

2016/10/21
Committee: ENVI

Motion for a resolution
Paragraph 19

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

2016/10/21
Committee: ENVI

Motion for a resolution
Paragraph 20

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

2016/10/21
Committee: ENVI

Motion for a resolution
Paragraph 20

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

2016/10/21
Committee: ENVI

Motion for a resolution
Paragraph 20

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

2016/10/21
Committee: ENVI

Nicola CAPUTO, Marc TARABELLA, Soledad CABEZÓN RUIZ

Motion for a resolution
Paragraph 20

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

2016/10/21
Committee: ENVI

Motion for a resolution
Paragraph 20 a (new)

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

2016/10/21
Committee: ENVI

Nicola CAPUTO, Marc TARABELLA, Soledad CABEZÓN RUIZ

Motion for a resolution
Paragraph 21 a (new)

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

2016/10/21
Committee: ENVI

Motion for a resolution
Paragraph 22

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

2016/10/21
Committee: ENVI

Motion for a resolution
Paragraph 22 a (new)

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

2016/10/21
Committee: ENVI

Motion for a resolution
Paragraph 22 a (new)

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

2016/10/21
Committee: ENVI

Motion for a resolution
Paragraph 22 b (new)

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

2016/10/21
Committee: ENVI

Motion for a resolution
Paragraph 23

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

2016/10/21
Committee: ENVI

Motion for a resolution
Paragraph 23

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

2016/10/21
Committee: ENVI

Motion for a resolution
Paragraph 23

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

2016/10/21
Committee: ENVI

Motion for a resolution
Paragraph 23 a (new)

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

2016/10/21
Committee: ENVI

Motion for a resolution
Paragraph 23 b (new)

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

2016/10/21
Committee: ENVI

Motion for a resolution
Paragraph 24

24. Calls on the Commission to set up a framework to promote, guarantee and reinforce the competitiveness and use of generic ~~medicine~~and biosimilar medicines in sustainable market conditions, guaranteeing their faster entry onto the market and monitoring unfair practices in accordance with Articles 101l and 1l 02 of the TFEU, and to present a biannual report in this regard;

2016/10/21
Committee: ENVI

Motion for a resolution
Paragraph 25

25. Calls on the Commission to propose legislation on a European system for health technology assessment as soon as possible, ~~and to assess added-value medicines~~to facilitate assessment of compared with the best available alternative; ~~also calls on the Commission to harmonise pricing and reimbursement criteria to take into account the level of innovation and the social and economic cost-benefit analysis, and~~such legislation shall ensure that HTA output jointly produced at EU level is user in national decision making process. It shall reflect the differences between pharmaceuticals and other medical technologies and procedures. It shall foresee joint Rapid Relative Effectiveness Assessment for pharmaceutical, strengthen early dialogues. it should consider a coordination mechanisms based on an independent body, which could foster cooperation between national HTA bodies and at the same time ensuring that expertise on HTA remains within national (and regional) HTA bodies. Could be helpful to put in place a European cClassification on the added value level of medicines;

2016/10/21
Committee: ENVI

Motion for a resolution
Paragraph 25 a (new)

25a. Calls on the Commission and the Member States to identify and develop frameworks, structures and methodologies in order to meaningfully incorporate patient evidence at all stages of the medicines R&D cycle, from early dialogue to regulatory approval, Health Technology Assessment, relative effectiveness assessments, and pricing and reimbursement decision-making with the involvement of patients and their representative organisations;

2016/10/21
Committee: ENVI

Nicola CAPUTO, Marc TARABELLA, Soledad CABEZÓN RUIZ

Motion for a resolution
Paragraph 25 a (new)

25a. Calls on the Commission to analyse the economic, social and ethical criteria which some Member States’ HTAs already apply and to establish common principles or guidelines in that regard on the basis of the usefulness of those criteria with regarding to pricing and reimbursement, then to decide whether the innovation quality is important to establishing its economic value, but not important enough to guarantee an appropriate cost- effectiveness relationship;

2016/10/21
Committee: ENVI

Motion for a resolution
Paragraph 25 a (new)

25a. Calls on the Commission to establish a permanent and single mechanism assessing relative efficacy of new medicinal products at EU level based on harmonized data requirements, so as to enhance patient access to new treatments and avoid duplications in drug assessments;

2016/10/21
Committee: ENVI

Motion for a resolution
Paragraph 26

26. Calls on the Commission and the Member States to promote major publicly funded investment in research based on unmet medical needs, and to introduce conditional funding based on affordable end pricing and non-exclusive licencing;

2016/10/21
Committee: ENVI

Nicola CAPUTO, Marc TARABELLA, Soledad CABEZÓN RUIZ

Motion for a resolution
Paragraph 27

27. Calls on the Council to increase cooperation between the Member States as regards price-setting procedures, in order to share information about prices, reimbursement, negotiation agreements and good practices and to avoid unnecessary administrative requirements and delays; also calls on the Council to ensure that Member States make greater use of the mutual recognition of authorisations;

2016/10/21
Committee: ENVI

Motion for a resolution
Paragraph 27 a (new)

27a. Invites the Member States to explore possible strategies on voluntary cooperation to jointly work on relative efficacy assessments of medicines, on common horizon scanning tools to allow for better budgetary planning and on measures enabling joint price negotiations in coalitions of Member States, that have expressed interest to do so;

2016/10/21
Committee: ENVI

Nicola CAPUTO, Marc TARABELLA, Soledad CABEZÓN RUIZ

Motion for a resolution
Paragraph 27 b (new)

27b. Invites the Member States to consider organising during each EU Presidency an informal meeting of relevant high level representatives from the Member States responsible for pharmaceutical policy (e.g. national directors of pharmaceutical policy), encouraging strategic reflection and discussion on current and future developments in the pharmaceutical system in the EU and its Member States; notes that these discussions could be used, where relevant, as an input for further reflection in the appropriate EU fora, in particular the Working Party on Pharmaceuticals and Medical Devices;

2016/10/21
Committee: ENVI

Motion for a resolution
Paragraph 29

29. Calls on the Commission and the Council to explore new measures to ~~control price~~address uncertainty on the expected budget impact ant to make sure that products are available in the markets, such as horizon~~tal~~ scanning and coordinating joint procurements;

2016/10/21
Committee: ENVI

Motion for a resolution
Paragraph 30 a (new)

30a. Calls on the Member States, under the supervision of the Commission, to enact the regulation on clinical trials in the scope of transparency and to study open access to those trials once they have been authorised for the market, and to push for the publication of all of the clinical trial results, including negative data, with a view to fostering research and economic growth;

2016/10/21
Committee: ENVI

Motion for a resolution
Paragraph 31

31. Calls on the Commission to propose a new directive on transparency of price-setting procedures and reimbursement systems, with a view to extending transparency to the market authorisation holder, and taking into account the challenges of the market;.

2016/10/21
Committee: ENVI

Motion for a resolution
Paragraph 31

31. Calls on the Commission to propose a new directive on transparency of price-setting procedures and reimbursement systems, taking into account the cha~~lle~~nges of the market;

2016/10/21
Committee: ENVI

Motion for a resolution
Paragraph 34

34. Calls on the Commission to examine and compare the prices of medicines in the EU, together with access to medicines, and to present an annual report to Parliament in this regard;

2016/10/21
Committee: ENVI

Motion for a resolution
Paragraph 36

36. Calls on the Commission to define ‘shortage’ and to analyse the causes of the shortages in the EU, to establish a ~~list of essential medicines and~~European list of essential medicines which uses as a reference the WHO’s list of essential medicines and a database on the medicines handled by the EMA, to monitor compliance with Article 81 of Directive 2001/83/EUC on shortages of supply, and to promote the supply of generics, and to draw up a report in that respect on an annual basis;

2016/10/21
Committee: ENVI

Motion for a resolution
Paragraph 36

36. Calls on the Commission to analyse the causes of shortages, to establish a list of essential medicines and monitor compliance with Article 81 of Directive 2001/83/EU on shortages of supply, and to promote the supply of generic and biosimilar medicines;

2016/10/21
Committee: ENVI

Motion for a resolution
Paragraph 36

36. Calls on the Commission to analyse the causes of ~~shortag~~medicines, to establish a list of essential medicines and monitor compliance with Article 81 of Directive 2001/83/EU on shortages of supply, and to promote the supply of generics;

2016/10/21
Committee: ENVI

Motion for a resolution
Paragraph 36 a (new)

36a. Notes the fragmentation of systems within the EU is presently very high and leads to duplication of efforts and misallocation of resources within the EU for Member States and industry. The lack of predictability has also an adverse impact;

2016/10/21
Committee: ENVI

Motion for a resolution
Paragraph 36 b (new)

36b. Calls to the Commission and Member States to coordinate a possible European joint procurement in the context of an European plan to eradicate hepatitis C;

2016/10/21
Committee: ENVI