The new European Commission says it will remove responsibility for medicines, including the European Medicines Agency, from the Directorate-General for Health and Consumers and give it back to DG Enterprise and Industry, in a development which has appalled health activists.
This “opaque and unjustified” decision by President-elect Jean-Claude Juncker’s new Commission “will put the commercial, profit-driven interests of the pharmaceutical industry, rather than patients and consumers, at the heart of European policymaking on medicines,” warns Health Action International (HAI). Pharmaceuticals are integral to enhancing public health, so they belong within the portfolio of DG Health and Consumers (DG SANCO), which is mandated to protect health and well-being, it says.
Jim Murray, a former director of the European Consumer Organisation (BEUC), has described the move as “a good day for the pharmaceutical industry, but a bad day for public health.”
No Directorate-General should combine the lead role for medicines policy with the lead role for the promotion of the pharmaceutical industry, says Mr Murray, writing on the EurActiv blogging platform BlogActiv. The difficult tasks of balancing the interests of public health and the legitimate interests of the pharmaceutical industry should not take place within the one DG, and should not be well-hidden from public scrutiny, he says, and also points to the difficulty of ensuring the right mix of skills within a single unit or DG, combining specialists in public health with expertise in industrial promotion.
The European Public Health Alliance (EPHA) has also condemned the move as “a potential disaster.” The group points out that among the reasons for moving health technology and pharmaceutical policy to DG SANCO in 2009 was to 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 the EU member states, all of which manage pharmaceutical policy under their health ministries.
“It is disappointing that President-elect Juncker believes these objectives fall a pale second place to appeasing big business,” said EPHA president Peggy Maguire. “The [EU] College of Commissioners should work for the interest of citizens and not anonymous corporate masters,” she added.
According to HAI, the transferral of the EMA to DG Enterprise and Industry is particularly troubling, and will create significant threats to clinical trial data transparency in the European Union (EU). “EMA had encountered significant opposition to its policy on public access to clinical trial data from the pharmaceutical industry in the last year. Now, the strong opposition from the industry will be more loudly heard by the EMA, and will most likely jeopardise independent review and, ultimately, patient safety,” the group warns.