New York TimesBy JAMES KANTERSEPTEMBER 10, 2014
BRUSSELS — Jean-Claude Juncker, the incoming president of the European Union’s executive branch, nominated his team on Wednesday, which will face challenges including reviving the flagging euro-area economy, curbing reliance on Russian energy and controlling migration into the bloc. The nominations come as part of the changes in European Union governance that occur every five years, and follow the election in May of a new European Parliament. Mr. Juncker’s nominees are subject to approval by the Parliament, which is expected to hold hearings on each appointee — but can only accept or reject the entire slate, rather than approve some nominations while blocking others…
A victory for profits over public health?by Martin McKee and Paul BelcherBritish Medical Journal. 2014 349:g5671 [Published 15 September 2014]News of the allocation by the European Commission’s president elect, Jean-Claude Juncker, of portfolios to the remaining European Commissioners has been eagerly awaited. This is an intensely political process, with the largest member states vying among themselves for the main economic roles. Would Juncker follow established precedent, giving health a low priority by allocating the portfolio to one of the countries with the smallest economies and thus, in effect, least political power in the European Union? … Or would he break with precedent and allocate it on the basis of merit, choosing the commissioner whose expertise and experience most closely matched the role? This time it seemed at least possible that Juncker would choose the second course, given that the line up included a very experienced candidate, Vytenis Andriukaitis, a Lithuanian surgeon who had been active in his country’s struggle for independence and gone on to become a successful health minister. European health policy experts were delighted when Juncker chose this course; subject to approval by the European Parliament, Andriukaitis will take up his role in November 2014.
Yet very shortly afterwards it became clear that the news was not all that it seemed. The allocation of jobs was accompanied by a restructuring of the directorates general [DGs]—in effect the ministries of the European Commission—without any explanation for the change. Three of the key units within the directorate general for health and consumers [DG SANCO] were to be transferred to the directorate general for the internal market, industry, and entrepreneurship [DG ENTR]. These were the units responsible for medicinal products and medical devices, including authorisations; that for quality, safety and efficacy; and the European Medicines Agency. This move reversed changes made by the previous European Union president, José Manuel Barroso, who in 2009 had brought these responsibilities within DG SANCO after a campaign led by pan-European health and consumer groups. Then, DG ENTR was seen as unable to provide the necessary leadership in the face of H1N1 influenza, especially in respect to emergency preparedness. The 2009 reorganisation also reflected a recognition of the need to harmonise the European Commission’s structures with those of its member states, where policies on pharmaceutical quality and safety were typically led by health ministries.
Inevitably, the latest change has provoked a furious response among health policy experts. Peggy Maguire, president of the European Public Health Alliance, described it as a “potential disaster,” arguing that Juncker was placing health concerns in “second place to appeasing big business.” In the same vein Monique Goyens, director general of the European Consumer Organization, said, “This shift gives European consumers the signal that economic interests come before their health.” In contrast, the body representing the European drug industry was delighted. Richard Bergstrom, director general of the European Federation of Pharmaceutical Industries and Associations, welcomed the move, expressing his “trust [that] the people in these units have the integrity to continue to put patient safety first. Critics of the transfer have three main objections…A third concern relates to the secrecy of the drug authorisation process, as described in great detail by Ben Goldacre in his book Bad Pharma. Glenis Willmott, a British member of the European Parliament, recalled, “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”
And then yesterday, Fiona Godlee [BMJ Editor] and Bruno Toussaint of Prescrire sent this letter to President Juncker:
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16 September 2014
To Jean-Claude Juncker, President of the European Commission Dear Mr Juncker, In 2009, President Barroso finally decided to place Commission policy on health products [medicines and medical devices] and the European Medicines Agency [EMA] under the responsibility of the Directorate-General for Health and Consumers rather than the Directorate-General for Enterprise and Industry. We and many others publicly welcomed this long-requested reform. It constituted an important guarantee that priority had been given to public health and patients rather than short-sighted economic and corporate interests. An incomprehensible step backwards. Your decision to transfer responsibility for drugs policy and the EMA back to the Directorate-General for Enterprise and Industry is a great disappointment, which none of the groups concerned about public health in Europe can understand. What are the reasons for this step backwards? What will it mean for the future direction of the EMA and for European patients? We have been watching the EMA’s work closely since its inception [1995]. It constantly and forcefully defends the interests of industry. Little attention is paid to the views of patients and health professionals. If the EMA’s policies are to be balanced, it must be more receptive to patients’ interests and the protection of public health. We will cite just one recent example. In 2010, the EMA announced a proactive policy on transparency and public access to the data on which the Agency bases recommendations that directly affect the health of European citizens. This policy was in line with an inexorable international trend towards greater transparency and with what MEPs and the European Council wanted to achieve as part of the new regulations governing clinical trials. To the astonishment of observers and of activists who had been deeply involved in this positive development, the EMA made a spectacular retreat in recent months, coinciding with the arrival of the new head of its legal service [whose background was in the pharmaceutical industry]. The EMA explained its change of heart by saying that it had to take into account the Commission’s position in ongoing negotiations on transatlantic trade. Put public health first. 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. President Juncker, bringing the EMA and industry even closer together endangers the health of European citizens. We feel that your decision was probably taken under the influence of commercial vested interests, but you still have the opportunity to take a better, more forward-looking decision, informed by a full understanding of the best interests of European citizens and their health. We are counting on you and the world is watching.
Fiona Godlee, editor in chief of the British Medical Journal
Bruno Toussaint, director of la revue Prescrire
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I can’t find any way in the world to read all of this without an overwhelming suspicion that it represents a behind the scenes move by the pharmaceutical industry [EFPIA]. But that aside, as the BMJ editorial says, it’s "A victory for profits over public health!"
There are endless numbers of pressure points in complex bureaucracies where money, favors, or threats might influence decisions. Pharma has the money to be very creative in finding them.