European Parliament (room JAN 6Q2), 2 December 2015, 13:00-15:00
We would like to invite you to the conference “It is not healthy: Mending the broken medicines innovation model” under the auspices of MEPs Marian-Jean MARINESCU (EPP, RO), Nessa CHILDERS (S&D, IE), Fredrick FEDERLEY (ALDE, SE – tbc), Lola Sanchez CALDENTEY (GUE/NGL, ES) with the support of the TransAtlantic Consumer Dialogue (TACD), the European Public Health Alliance (EPHA), Médecins du Monde (MdM) International network, Universities Allied for Essential Medicines (UAEM Europe), Salud Por Derecho in collaboration with the European Parliament Working Group on innovation, access to medicines & poverty-related diseases.
Health is a fundamental universal right and access to medicines is part of it. The EU and its Member states are committed to universal and equitable access to healthcare. Nevertheless, millions of European patients suffer from the lack of affordability of many life-saving medicines across Europe. The debate will examine the status quo regarding access to medicines in Europe and explore policy recommendations for more affordable medicines. Possible solutions to be considered will be: price and data transparency, cost-therapeutic benefit assessment of medical products and greater generic competition. We shall also debate new biomedical R&D strategies that increase the social return of public investments and promote affordable health-driven innovation which “de-links” research costs from final medicine prices.
Programme (13:00-15:00, room JAN 6Q2)
Welcoming remarks by sponsoring MEP
What is the diagnosis for our medical innovation and medicines pricing ills?
Introduction by sponsoring MEP
Moderated by Yannis Natsis @ynatsis, advocacy advisor on access to medicines, TACD
- Xavier Prats Monné, Director-General, DG SANTE, European Commission (to be confirmed)
- Teresa Alves, International Policy Adviser, La Revue Prescrire
- Dr. Fernando Lamata, @LamataF, Consejería de Sanidad de la Comunidad de Madrid, Madrid, Spain – member of the EC’s Expert Panel Working Group on access to health care
- Dr. Antje Haas, Head of our pharmaceuticals department, GKV-Spitzenverband
What are some of the possible cures for our ailing and expensive pharmaceutical model?
Introduction by sponsoring MEP
- Rachel Kiddell-Monroe, @Access2Rachel Special Advisor to Universities Allied for Essential Medicines (UAEM) @UAEM
- Dr. Bernard Pécoul, Executive Director, Drugs for Neglected Diseases Initiative (DNDi) @DNDi
- Els Toreele, @ElsTorreele Director of the Open Society Public Health Program’s Access to Essential Medicines Initiative @osfHealth
Concluding remarks by sponsoring MEP
Please join the discussion on twitter using #unHealthy.
We would kindly ask you to register your attendance (please mention title & organisation represented) by sending an email to firstname.lastname@example.org by Wednesday 25 November 2015.
Should you require a badge to access the European Parliament, please do not forget to provide us with your full name, nationality, passport/ID number and date of birth. Badges will be handed out at the “Altiero Spinelli” entrance of the European Parliament on Rue Wiertz 60 as of noon on the day of the event (please look for respective desk/poster).
A light lunch will be served at the start of the hearing.
EUROPEAN COMMISSION EXPERT PANEL ON EFFECTIVE WAYS OF INVESTING IN HEALTH
Access to health
services in the European Union
approved this opinion for public consultation
by written procedure on 25 September, 2015
Public Consultation is open until November 8th, 2015
Expert Panel members
Margaret Barry, Helmut Brand, Werner Brouwer,
Jan De Maeseneer
Bengt Jönsson (Vice
MEDICINES: p. 71 to 81 that includes this reference and the below recommendations.
The current system of funding R&D through medicine prices encourages
pharmaceutical companies to focus on areas likely to be most
profitable for them rather than areas in which there is unmet need.
The European Union could, however, find more effective ways of funding
R&D to meet health needs (Bloemen and Hammerstein 2012). An interesting line
of development would be to de-link prices and R&D costs (WHO 2012a; WHO
2012b). In 2010, Council Conclusions on the EU’s role in global health asked
Member Sates to explore this option and to ensure that EU investments in health
research secure access to the knowledge and tools generated as a global public
good and generate socially essential medical products at affordable prices.
The European Union can support
Member States in the following ways:
Promote joint action to develop a
strategy to ensure equitable access to new
medicines and new innovative treatments and fairer prices.
Promote transparency to ensure that patents serve the social purpose for which
they were created. This requires detailed knowledge of costs and prices. Wthout this information there is a risk of patent misuse.
Evaluate the possibility of
withdrawing patents in cases of misuse.
Consider setting up a European Parliament committee to analyse the prices of new
medicines. The committee should be guaranteed transparency around costs and prices.
Review the impact of the Supplementary Protection Certificate in ensuring access
to medicines (De Boer 2015).
Link products that have benefited from EU funds such as Horizon 2020 to socially
Explore models to separate the cost of R&D from prices (Council Conclusions May
10, 2010) and extend these to EU countries (not just low
Evaluate and promote the use of joint procurement mechanisms.
Decouple the financing of EU regulator
y agencies (the European Medicines Agency,
EMA) from the pharmaceutical industry. Currently, 83% of the EMA’s budget comes
from the industry via authorisation fees).
Introduce stricter control over conflicts of
All diseases “rare” to evade regulation.
No data on elderly polymedicaton or women specific med impacts.
“There is an attempt to circumvent EMA regulations for the approval of new drugs by making every disease a rare one”, in order to take advantage of fast-track approvals with fewer requirements of clinical trials and provision of data on the efficacy and safety of new medical products.
Rasi was questioned by Spanish Socialist Soledad Cabezón on why the EMA did not evaluate the quality of the medicines compared with those already on the market. She also asked whether the EMA had any plans on making transparent the R and D costs of new medicines as well as improving clinical trial transparency for the sake of health technology assessment. Rasi responded by stating that “commercial” questions were not the competence of the EMA but of the member states. Rasi added that EU member states were capable of evaluating the cost-benefit of the new products if they used their resources wisely.
When asked about TTIP Rasi said that he was not following this issue in detail.
MEP Nessa Childers asked Rasi about the impact of medicines on the elderly and women.
Rasi stated that “We don´t have data or a clear scientific model on the inter-action of the many drugs that elerly people take at the same time. The same goes for women who undergo hormonal changes as they get older that changes the way they react to medicines.” He hoped new research with help. Rasi added that “personalized medicine with surrogate indicators” could be a big help to solve the problems of the elderly and women.
The false competence issue to ECJ
In July the European Commission sent a legal consultation to the European Court of Justice on the issue of whether the Marrakesh Treaty should or should not be ratified under the exclusive competence of the European Union. The reason the EC finally sent the consultation was to prevent a few individual EU member states from ratifying on their own. The ECJ opinion could take between 9 and 18 months but this does not prevent the Council of EU Ministers from ratifying the Treaty at any time. The European Parliament legal service has submitted to the ECJ its very clear opinion in favour of EU exclusive competence along the same lines as the Commission and the Council legal services have expressed. There is no doubt that the Court will rule it is the EU´s exclusive competence to ratify. The consultation can also be seen as a delaying tactic to divert attention from the blockage in the Council.
The other related news is that the European Commission is preparing a “Marrakesh Directive” to better implement the Treaty. The proposal that we hope will be practically a “copy-paste” of the Treaty will probably be out in December. It should be stressed that this is not at all a pre-requisite for ratification and, if it were necessary, could have been done after ratification. As well, the approval of a “Marrakesh Directive” will not in any way change the opposition of some Member States on the competence issue. Nevertheless, we must be alert about the content of this proposal to make sure it has the most favourable interpretation of the Treaty.
German blocking of Treaty
Treaty ratification is now supported by 21 of 28 EU Member States. If Germany changed its negative position, the “blocking minority” in the Council would probably collapse. This calls for political pressure on a political level in Berlin, both in the Justice Ministry and with political parties. To date very few people in the German Government and the Bundestag know anything about Germany´s blocking of the Treaty by using very dubious and totally unsubstantiated arguments: that it is not EU competence, that we need to change German copyright law first and that we need a new EU Directive first. All legal expert have told us the contrary. This is obviously a deceitful political ploy that needs to be exposed. Italy is using the same arguments. The UK´s position on competence is more of a result of the general “euro-skeptic” political ambience.
European Parliament takes action
In the last few weeks both the Legal Affairs Committee and the Petitions Committee have responded positively to the requests of the European Blind Union. Both have decided to send a letter via Martín Schulz, the European Parliament President, to the Luxembourg Presidency of the Council and to Donald Tusk(with copy to Member States), the permanent President of the Council, requesting immediate ratification of the Treaty. We shall circulate the texts when we gain access to them. Other measures, such as a resolution in the EP plenary and a press oriented event have also been requested by the EBU representatives to the Petitions Committee and we are awaiting a reply.