Brussels, 22 October 2014
Joint press release (ISDB, MiEF, NCC). EU Commission President Jean-Claude Juncker has reconsidered: competence for medicinal products is finally to remain with the Health Commissioner.
> Download the joint press release (pdf, 268 Ko)
Joint press release
In early September 2014, when presenting his team for the new EU Commission, President Juncker announced his decision to move competence for medicines and medical devices from the Health Commissioner to the Commissioner for internal market and industry. The news prompted a public outcry. Numerous civil society organisations, Members of the European Parliament and Health Ministers from several Member States expressed their astonishment and concern, and called on Mr Juncker to abandon this portfolio change (1-5).
Mr Juncker initially rejected these pleas, insisting that he had included "A Deeper and Fairer Internal Market with a Strengthened Industrial Base as a priority in [his] Political Guidelines" (6). On 22 October 2014 however, Mr Juncker reconsidered and decided to leave competence for medicinal products with the Health Commissioner (7).
A positive sign, which should be more than symbolic
We hope that Mr Juncker's change of heart is a sign of a change in priorities, rather than a strategic political move. We hope that Mr Juncker realised that EU policy on pharmaceuticals and health technologies should be driven first and foremost by the promotion and protection of health and patient safety.
Moreover, lessons should be learned from the experience of recent years. In December 2009, the relocation of medicinal products to the Health Commissioner was an advance, at least in principle, but in practice it was not enough to realign EU policies with public health. For instance, recent negotiations over the EU Clinical Trials Regulation and the saga of the European Medicines Agency (EMA)'s policy on increased access to clinical data have shown that the EU Commission remains reluctant to accept greater transparency. Progress was only achieved thanks to the mobilisation of civil society organisations, healthcare professionals, consumers, independent researchers, Members of the European Parliament, the EU Ombudsman and the Ministers of Health of Members States (8,9).
Put health first
We sincerely hope that Mr Juncker's decision to leave medicinal products under the responsibility of the Health Commissioner means that, in the future, public health and patient safety will have priority over the short-term competitiveness of the medical products industry, particularly in cases where patients' needs do not coincide with the interests of industry (1).
We therefore call on the new Commission, and particularly on the new Health Commissioner Dr Vytenis Andriukaitis, to tackle the following public health priorities:
- Ensure greater transparency of clinical data, including pharmacovigilance data (a) (10); anonymised individual patient data ("raw data") should be made available, to allow reanalysis of the results of clinical trials (9); the EMA must be compelled to set up, without further delay, a public online register of documents held by the agency (b) (9);
- Demand robust evaluation of new drugs before marketing authorisation is granted, notably by requiring comparative trials against a reference treatment in order to demonstrate whether the new drugs adds any added therapeutic value (therapeutic progress), rather than supporting initiatives that aim to deregulate the system, such as the EMA's controversial "adaptive licensing" pilot project (11);
- Reinforce the independence of Drug Regulatory Agencies and free them from pharmaceutical company influence (by allocating public funds for their activities to replace the current fee-for-service system, and by eliminating conflicts of interest and revolving door practices) (12,13);
- Defending EU citizens' right to obtain compensation for harm caused by medicinal products or medical devices: medicines and medical devices are not mere commodities, but products which inherently carry high risks and should therefore be outside the scope of Directive 85/374/EEC on liability for defective products (14,15).
We also urge the new EU Commission to ensure that the US/EU Transatlantic Trade and Investment Partnership (TTIP), currently under negotiation, does not lower European safety standards, impede transparency, impose greater protection of intellectual property (IP) rights, or further expand monopoly protection, thus keeping the price of new pharmaceutical products high and jeopardising access to medicines in Europe and beyond (16).
International Society of Drug Bulletins (ISDB)
Medicines in Europe Forum (MiEF)
Nordic Cochrane Center (NCC)
©ISDB, MiEF, NCC October 2014
Notes:
a- EMA policy on access to pharmacovigilance data is unsatisfactory (ref. 10). Moreover, the EU Commission's proposal for a directive on trade secrets, published in November 2013, currently under discussion in the EU Parliament, poses a real threat to transparency, since it could undermine the advances in clinical data transparency established in the recently adopted Regulation on clinical trials.
b- The EMA should have established such a register more than ten years ago, in compliance with Regulation (EC) 1049/2001.
References:
1- "Medicinal products and health technology belong under the responsibility of the Commissioner for health" Joint open letter to President Juncker by 28 organisations (AGE, AIM, BEUC, CEO, CPME, EAHP, EATG, ECL, EFA, EHMA, EHN, ELPA, EMSA, EPF, EPHA, ESIP, HAI, HEAL, HOPE, IDF, IFMSA, ISDB, MiEF, NCC, PGEU, SFP, UAEM, UEMS) 16 September 2014: 1 page. > Available here
2- Godlee F (BMJ) and Toussaint B (Prescrire) "Mr Juncker, medicines are not just a commodity..." Open letter to Jean-Claude Juncker, President of the European Commission. 16 September 2014: 1 page. > Available here
3- President Schulz on behalf of ENVI chair and coordinators of EPP, S&D, ALDE, GUE/NGL and Greens/EFA "Letter to President-elect Juncker (Reference 314827)" 16 September 2014: 2 pages.
4- "Sept pays, dont la France, s'élèvent contre la politique du médicament en UE" www.lemonde.fr 25.09.2014.
5- Murray J "Clearing the Air on Transparency Decisions, and on Industry Demands to the Juncker Commission" openmedicineeu.blogactiv.eu; 1 October 2014.
6- Juncker JC "Response to President Schulz and ENVI coordinators (reference Ares (2014) 3190042)" 29 September 2014: 2 pages.
7- Robert A "Jean-Claude Juncker affine le casting de la nouvelle Commission" Euractiv.fr ; 22 October 2014.
8- AIM, BEUC, ISDB, MiEF, NCC, TACD, Wemos "New EU Clinical Trials Regulation: a major advance in transparency, to be confirmed" Joint briefing paper; 23 September 2014: 4 pages.> Available here
9- AIM, HAI Europe, ISDB, MiEF, NCC "EMA's final policy on access to clinical data: proactive access to some data, but strings attached" joint statement; 16 October 2014: 4 pages. > Available here
10- Cochrane Adverse Effects Methods Group (AEMG), HAI Europe, ISDB, MiEF "EMA's policy on pharmacovigilance: access to qualitative data is needed, pharmacovigilance data are not "trade secrets"" Joint response to EMA public consultation; 15 September 2014: 17 pages. > Available here
11- EPHA, ISDB, Wemos "Added Therapeutic Value: European citizens should get their money's worth" Joint position paper; September 2014: 3 pages.
12- AIM, HAI Europe, ISDB and MiEF "Providing "scientific advice" to pharma industry undermines the independence of regulatory authorities" Joint consultation response to the EMA's public consultation on its ‘Best practice guidance for pilot EMA HTA parallel scientific advice procedures'; 15 July 2014: 6 pages. > Available here
13- HAI Europe, ISDB, MiEF "Final proposals on pharmacovigilance: Some progress, but a missed opportunity to genuinely strengthen patient safety" Joint press release; 7 December 2010: 2 pages. > Available here
14- "Council Directive 85/374/EEC of 25 July 1985 on the approximation of the laws, regulations and administrative provisions of the Member States concerning liability for defective products" OJ L 210, 7 August 1985, p. 29–33.
15- Le Pallec S ""Gueules cassées du médicament": d'épreuves en épreuves" Speech at Prescrire's "Pilule d'Or" event; 29 January 2014: 4 pages + video (14 minutes, in French). > Available here
16- HAI Europe and Oxfam "Europe seeks to expand big pharma monopoly at expense of poor people, warn NGOs ahead of TTIP talks" Joint press release 29 September 2014. http://haieurope.org: 2 pages.
> Download the joint press release (pdf, 268 Ko)
