The president of the European Parliament has called for a "satisfactory response" from Mr Juncker before the commissioner hearings begin. MEPs from several political groups and the Belgian Minister of Health joined the public health community in calling for medicinal products and health technology to be moved back in to the health portfolio of the European Commission. This adds to the voices of European and global players representing various branches of healthcare that expressed concerns on the unexpected and dangerous decision.
Strong voice of EU leaders, academics, and health organisations united against the EU Commission pharma policy move.
Ms Onkelinx, the Belgian Minister of Health argues that this decision is a “step backward” and “ incomprehensible”. In a press release she says, “the breast plant scandal should remind the European Commission that considering a health product a commodity seriously puts public health at risk. It is time to stop commercialising healthcare.”
Minister Laurette Onkelinx launched a discussion during the informal Health Council. Ten member states expressed concern regarding the planned reorganisation of the European Commission’s services. This included colleagues from France, Cyprus, Austria, Greece, Bulgaria, Slovakia, Lithuania, Portugal and Romania.
President of the European Parliament
Martin Schulz, President of the European Parliament, (S&D Germany) has written to President-Elect Juncker on behalf of the ENVI Chair and the EPP, S&D, ALDE, Greens/EFA, and GUE/NGL Coordinators. In his letter, the ENVI Committee asks for health technology and pharmaceutical policy to stay in the health portfolio to ensure a "coherent approach" to health policy.
“Last but not least”, Schulz concludes, the committee “believes that a coherent approach in public health policy would ensure the highest level of health protection”. It is asking, continues to Schulz, “to keep responsibility for health technology, cosmetics, medicinal products and the European Medicines Agency in DG SANCO”.
“I would greatly appreciate a response to these concerns before the start of the hearings” on Monday, Schulz says. His letter opens with a reminder that “in the coming weeks, the European Parliament will exercise its most fundamental right…, namely the appointment of members of the college of commissioners”.
Members of the European Parliament (MEPs)
Peter Liese, (EPP Germany) says that for the safety medicines and medical devices, the move should be "re-considered". He points out that as the legislation on medical devices has not been finished, "a complete re-organisation of the locations in the Commission is not helpful."
The newly appointed rapporteur for the legislation on medical devices, Glenis Willmott (UK S&D), is questioning the move as well. "I am concerned, however, with the proposals that medical devices should fall under the responsibility of the industry commissioner. Our first priority with these products must be health, and they should be overseen by the health commissioner. I will be doing everything I can to ensure that this is the case."
Irish ALDE MEP Marian Harkin objected to the idea of moving medicinal products and health technologies from the health to the internal market/enterprise department, which in her view could prioritise profits over patient safety. This view was shared by Matthias Groote, a German centre-left MEP and former chairman of the Parliament’s environment committee, who said that the move of medicines “sends a bad signal about the commercialisation of health”.
"The transfer of competences made by Barroso from DG Enterprise and Industry to DG Health and Consumers was a response to a growing demand in order to put public health interest above enterprises interest. The decision taken by Juncker a step backwards to ensure the highest level of health protection."
Sergio Guttierrez Prieto (S&D Spain), member of the Internal Market and Consumer Committee, tabled a parliamentary question on the move.
Green vice-president and health spokesperson Michele Rivasi, raises concerns regarding the “commercial logic” of the decision and its impact on healthcare: "While the EU is facing this crisis of access to healthcare, we are also concerned about the future direction of the European Commission in terms of healthcare. President-elect Juncker has announced he is moving the competence for medicines and medical devices to the industry directorate in the European Commission. That such a sensitive area in terms of the general public interest is to be approached from a purely commercial logic is clearly a cause for concern and we intend to raise this in the forthcoming European Parliament hearings."
Denis De Jong, the GUE-NGL Coordinator of the IMCO Committee said, "President Juncker stated in his reply to the letter which I sent together with other MEPs that public health will be as least as important as internal market considerations in the context of medicines and medical supplies. That simply is not good enough: it should not become a balancing act. For me, public health comes first and should not be left to the market. "
In a debate about access to medicines in Europe, Biljana Borzan (S&D Croatia), Margrete Auken (Greens/EFA DK), and Dario Tamburrano (Italy Movimento Cinque Stelle) brought up the transfer, expressed concerns regarding promoting economic interests before patient needs and asked if this would promote better health when pharmaceutical policy is governed by health ministers at the national level.
Jude Kirton-Darling (S&D, UK), a substitute on the ITRE Committee, said "Health concerns must always trump market concerns when it comes to medicines. Authorising new drugs, controlling their safety, quality and efficacy requires first and foremost a health perspective, not a market perspective"
Paul Brannen MEP (S&D, UK), a substitute on the ENVI Committee, warned "This move is not just an unfortunate symbol, it could have some very practical implications in the way the EU treats medicines. NGOs have done Europe a big favour in uncovering this issue. We will now do our part in the Parliament to secure the safeguards that our common health policy requires."
Leading medical academics have also criticised the move Fiona Godlee, editor in chief of the British Medical Journal and Bruno Toussaint, director of la revue Prescrire wrote an open letter to Juncker saying this was an “incomprehensible step backward” prompting the questions “What are the reasons for this step backwards? What will it mean for the future direction of the EMA and for European patients?”
The letter argues that "experience has shown that the interests of pharmaceutical companies only coincide with the interests of public health when companies are encouraged to focus on real and pressing health needs, are obliged to evaluate their drugs sufficiently, and when their marketing activities are monitored. Too many medicines introduced on the European market offer no tangible therapeutic advantages for patients, and some are inferior to existing treatments.”
Martin McKee, professor at the London School of Hygiene and Tropical Medicine and Paul Belcher, strategic adviser to the EPHA president and board point out that “recent national and European elections revealed a combination of disillusionment and outright hostility to the European idea. Taking responsibility for medicines from those charged with safeguarding public health and giving it to those whose goal is to support an industry whose track record is decidedly mixed seems a strange way to improve this situation.”
They point out three objections;
the failures of the current model of pharmaceutical discovery and development have been unfolding in the glare of publicity surrounding the Ebola outbreak. This prompts the question of how DG SANCO will be able to fulfil its mandates in respect of preparedness for infectious diseases, such as pandemic flu, and biological or chemical terrorism
this undermines alternative ways to create incentives to bring new drugs to market going beyond enhanced protection of intellectual property rights and could undermine increasing added therapeutic value
the secrecy of the drug authorisation process including the transparency of clinical trials data
Civil Society reaction
The change proposed by Jean-Claude Juncker will further greatly threaten objectives around patient safety, access to medicines, control of infectious disease outbreaks, coordination of vaccines and general public health interests. Partners who share this concern are now forming a strong coalition against the maldistribution of the tasks among the College of Commissioners.
All stakeholders are united in the belief that health interests should come before market considerations and strongly advocate the urgent revision of where the responsibility for pharmaceutical and medical devices policies truly belong.
This joint civil society letter will send a strong statement ahead of the Commissioner hearings and before the informal EPSCO (Employment, Social Policy, Health and Consumer Affairs) Council meeting of health ministers which takes place on 22 and 23 September (in Milan, Italy) on innovation in pharmaceuticals and access to medicines.
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