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Prescrire maintains all 5 complaints filed with the European Ombudsman, following the response by the European Medicines Agency (EMA)

Prescrire filed 5 complaints with the European Ombudsman on 30 August 2010, citing repeated refusals by the European Medicines Agency (EMA) to provide documents and information, in particular concerning drugs with a negative risk-benefit balance. After EMA's response in January 2011, Prescrire has decided to maintain all 5 of its complaints.

Prescrire is an independent source of information on drugs.

Over the last few decades, several scandals involving drugs such as rofecoxib (Vioxx°) and benfluorex (Mediator°) have had devastating public health consequences for European populations. Other drugs, such as rimonabant (Acomplia°) and buflomedil (Fonzylane°), were withdrawn after being marketed for years. While they were on the market, these drugs caused serious adverse effects in thousands of patients. Yet they were all licensed by drug regulatory agencies, including the EMA.

These scandals have also shown that it is difficult to get access to information about drugs, especially the information held by drug regulatory agencies, confirming the need for transparency affirmed in 1996 in the Uppsala Declaration and the International Society of Drug bulletins (ISDB). These scandals have also shown that in order to evaluate a drug, it is necessary to ask questions and to examine, compare and cross-check information from multiple sources. For this reason, Prescrire’s approach for decades has been to consult various essential sources of information on drugs: primary publication journals and reference works, other independent teams that evaluate medicines, pharmaceutical companies and drug regulatory agencies.

We are well aware that regularly questioning the drug regulatory agencies, including the EMA, creates work for their staff. This approach is all the more justified since only a small fraction of the information held by the regulatory agencies is made publicly available. The EMA’s administrative processes, and especially reviews of drugs suspected of causing serious adverse effects, are too long in the face of the pressing need to safeguard patients and European populations. These drawn-out processes benefit the pharmaceutical companies that market the drugs in question. But they also delay the sharing of knowledge about these drugs’ adverse effects and deprive healthcare professionals and patients of the opportunity to take this knowledge into account when deciding which treatments to use.

Throughout our requests for information, the EMA has regularly demonstrated its conception of the protection of commercial interests, which gives this protection priority over the transparency of clinical data.
The European Medicines Agency’s role is to safeguard patients and European populations. The clinical data in its possession are common property and a matter of public interest. These data contribute to the knowledge of drugs, and especially of their adverse effects. They belong no more to pharmaceutical companies than to the entire community. In all circumstances, the importance of disclosing these data, in terms of public health, surpasses the importance of protecting commercial interests.

•  •  •

Most of the requests mentioned in our complaints reflect maladministration practices by the EMA, which doubtless go beyond Prescrire’s requests for information:

  • unacceptably long delays before disclosing information, particularly about adverse effects;
  • insufficiently explicit responses, that rarely enable us to fine-tune our requests;
  • blatant refusals to provide documentation.

Claiming that EMA documents cannot be released until the European Commission has made its Decision is yet another way of avoiding transparency. If the European Union accepts such a practice, it will be a serious setback for transparency. Civil society will see where the Community administrations’ chosen priorities lie.

We have studied the EMA’s new transparency rules from November 2010. We will observe their implementation and their limits. Because although these rules were supposed to bring out into the open certain types of document that the EMA had previously kept under wraps, they still only apply to a restrictive list of documents produced and held by the EMA, and therefore represent a limited interpretation of Regulation EC No 1049/2001 concerning public access to administrative documents.

We call on the EMA to provide public access through its website to a comprehensive register of all the documents it holds: all of those it produces and all of those it receives.
Information about the adverse effects of drugs is scientific data. The EMA has no right to refuse teams of healthcare professionals like Prescrire access to such data, on the pretext of their commercially confidential nature or the fact that an administrative procedure (the one conducted by the EMA and the Commission) is still underway.

We call on the EMA:

  • to provide immediate public access through its website to all supporting documents in its possession, relating to its recommendations.
  • to provide public access to the raw data held in its databases, and especially the EudraVigilance database.
  • to rapidly meet all its obligations in terms of transparency. For example, it is high time the Commissions’ detailed agendas were released.
  • to rapidly provide public access to the minutes and scientific opinions of all of its committees, working parties and other groups.
  • to rapidly provide public access through its website to conflict of interest statements for all of its experts and participants of committees, working parties and other groups.
  • to provide more constructive responses to concerned parties, and to help them determine how best to formulate their requests where appropriate.

Licensing drugs with unfavourable harm-benefit balances and not suspending marketing authorisations when a drug is suspected of posing a serious threat, are in themselves acts of serious maladministration. Pharmaceutical companies benefit, at the expense of the patients who remain exposed to these risks. As our requests show, the EMA persists in limiting access to information. There are concerns that this is one way in which the EMA gives priority to the interests of marketing authorisation holders.

This policy is seriously damaging to public health. On the other hand, a policy focused unequivocally on public health would lead to transparency on all clinical data, and especially data on adverse effects.

©Prescrire 6 April 2011

For more information:

Read the full document
Pdf, free

Read the report from
the European Medicines
Agency (EMA) in response
to Prescrire's complaint
(January 2011)
Pdf, free

Prescrire files a complaint
against the European
Medicines Agency (EMA)
(September 2010)

Read the complaint filed
by Prescrire against the
European Medicines Agency
(August 2010)
Pdf, free

See also:

Legal obligations for
transparency at the
European Medicines Agency:
Prescrire's assessment
over four years
Prescrire Int 2009 ;
18 (103) : 228-233.
Pdf, free