12 September 2014, Brussels – The public health community has reacted with alarm and disbelief at the ill-thought distribution of responsibilities amongst the in-coming European Commissioners.
In an announcement on Wednesday 10 September, the President-elect (1) revealed that health technology and pharmaceutical policy is being moved from the Health and Food Safety Commissioner to the new Commissioner for Internal Market, Industry, Entrepreneurship and SMEs (2). The European Public Health Alliance cannot support this decision which threatens Europe’s ability to prepare for major health crises such as outbreaks of infectious diseases and health threats arising from climate change, whilst putting the public interest behind the drive for profits in drug authorisation procedures.
The European Public Health Alliance believes that this move undermines the College of Commissioners and will deepen the rift between the institutions and ordinary people. We also deeply regret that the decision had not been subject to public debate, the lack of explanation provided for this policy shift, and that the announcement of portfolios came after the deadline for written questions in the Parliament. The unfortunate timing essentially inhibits the European Parliament’s right of scrutiny.
Health technology and pharmaceutical policy was transferred to the Health Commissioner in 2009 to, among other reasons (3), facilitate emergency preparedness (in response to the emergence of H1N1 and the alleged inability of DG Enterprise to provide the necessary leadership and coordination of vaccines) and to harmonise pharmaceutical governance along the lines of Europe’s Member States, all of whom manage pharmaceutical policy under their Ministries of Health.
“This is a potential disaster. President Barroso took the decision to strengthen Europe’s ability to respond to pandemics, and to bring the European Commission in line with national governments. It is disappointing that President-elect Juncker believes these objectives fall a pale second place to appeasing big business,” said Peggy Maguire, President of EPHA. “It sends a terrible message during times when criticism is being levelled at Europe: the College of Commissioners should work for the interest of citizens and not anonymous corporate masters,” continued Ms Maguire.
With the responsibility for pharmaceutical and medical devices policies removed from the Commissioner for Health and Food Safety, Dr Andriukaitis the nominated Commissioner-designate, has effectively been denied the opportunity to achieve what his services are being requested to do.
Pharmaceutical policy is an integral part of public health policy making. Medicines form a major part of prevention and treatment measures and are therefore of key importance in safeguarding health. Access to safe, effective and high quality medicines (4), accompanied by independent and unbiased information to patients, is a minimum requirement for sustainable health systems. Previous experience with the Directive on information to the general public on medicinal products subject to medical prescription demonstrated the difficulty of providing information that must be reliable, comparable, objective and user-friendly when the main policy consideration was increasing sales. (5)
“When I was negotiating the transparency laws for clinical trial results, it was DG Enterprise that wanted to water the rules down. Now they will be overseeing the European Medicines Agency as it implements the transparency regime, which is frankly concerning,” said Glenis Willmott, MEP S&D UK.
“President-elect Jean-Claude Juncker, the College of Commissioners, the European Parliament and Europe’s Ministers of Health must all support an inclusive, coherent approach to health that acts in the public interest,” concluded Peter Wiessner, EPHA Vice-President.
– Notes to the editors
(3) EPHA welcomes transfer of pharmaceutical policy to DG Sanco – November, 2009
(4) Press release] [Joint declaration on access to medicines: ringing alarm bells on a deepening problem
(5) EPHA Position Paper on Information to Patients on prescribed medicines Contact information.
– Contact information
Javier Delgado Rivera, EPHA Communications Coordinator at javier@epha.org or +32 (0) 2 233 38 76 / (m) +32 (0) 484 919 156.
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Explanatory background notes <img7253|center>
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Juncker puts Europe’s security at risk by promoting profit over public health.
The decision of the President-elect Jean-Claude Juncker to move the governance of key dossiers relating to public health from the Commissioner responsible for health and food safety to the Commissioner responsible for enterprise and industry is not a decision that the European Public Health Alliance (EPHA) can support.
The proposed change in the responsibilities of the new College of Commissioners unveiled by President-elect Jean-Claude Juncker this week is in direct contradiction to the need for a coherent and unified health policy within the European Union.
EPHA is not alone in its criticism of this move. Other key organisations working in healthcare have also voiced their opinions in line with EPHA’s concerns:
“We are dismayed the competence on medicines and medical devices is no longer in the hands of the Health Commissioner. Policies on pharmaceuticals and medical devices such as breast implants and hip prostheses should be designed to promote and protect public health. But DG Enterprise’s job is to promote the competitiveness of the industry. This shift gives European consumers the signal that economic interests come before their health,” said Monique Goyens, Director General, BEUC – The European Consumer Organization.
“AIM regrets that the EU Commission is backpedalling by shifting vital elements related to health such as medicinal products and medical devices to DG Industry and Entreprise. AIM urges to put health of European Citizens in the right hands. This can only be done by DG Health!,” added Christian Zahn, President of the International Association of Mutual Benefit Societies (AIM).
“It is doubtful, that a Commissioner responsible for the Single Market and Industry will strongly advocate for patients’ interests. As representatives of social insurances and patients in Europe we fear that this decision will overemphasize industry interests in future policy making regarding health products and technologies. Shifting the portfolio to DG Enterprise is exactly the wrong signal for ensuring patient safety,” commented Dr. Franz Terwey, President of the European Social Insurance Platform (ESIP).
The basis of our criticism of this shift of pharmaceutical competence within the European Commission is based on the following:
– Tightening coordination between national health authorities in the case of major health crises such as outbreaks of infectious diseases, food safety scares, biological or chemical terrorism, and health threats arising from climate change is a priority for and a mandate of the new Heath Commissioner (as set in his mission letter). In the case of pandemics, such as the H1N1 virus, it would be his role to frame the appropriate response. With the allocation of medicines needed to manage such outbreaks with the Commissioner for enterprise rather than health, there is a strong risk that market objectives will take the lead over immediate health concerns.
– In the current debate over the pricing of novel drugs, such as Gilead’s outrageously expensive Sovaldi Hepatitis C treatment, we feel it is ill-advised to allow the regulation of drug authorization policies to fall under the remit of a directorate who prioritises market concerns over public interest.
– Patients deserve and require the best unbiased information possible. This needs to be regulated as a part of a larger health policy without industry interference and under the guidance of health care professionals and researchers.
– Medicine regulation needs to be patient driven, the move back to DG Enterprise does not support this. This regressive measure places medicines well and truly in the heart of ‘the market’ instead of being a priority for the health and well-being of all.
– The shift to enterprise and industry raises serious questions about who will profit from future legislation on medicines.
-* For more information:
. The European Commission and pharmaceutical policy; A victory for profits over public health? – co-authored by Paul Belcher, EPHA strategic adviser to the president and board, and Martin McKee, professor of European public health at London School of Hygiene and Tropical Medicine, The British Medical Journal (BMJ)
. Why Juncker should backtrack and keep pharma policy in the health portfolio – op-ed at EurActiv – Brussels-based media outlet.
. Juncker plays into the hands of big pharma – letter to the editor, by Emma Woodford, EPHA Interim Secretary General in the Financial Times.
. Juncker’s health plans drive a wedge between partners – European Voice.
. Intergroup boycotted over change in Health portfolio – New Europe – Brussels-based media outlet.
. Juncker should reverse decision on medicines shake up – by MEP Glenis Willmott (S&D, UK)
. A Bad Start for the New Commission – by Jim Murray (OpenMedicine.EU)
. New European Commission announced: First BEUC comments – The European Consumer Organisation (BEUC)
. Public health in danger with move of pharmaceutical policy to DG Enterprise and Industry – Health Action International (HAI)
