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Summary of the decision in case 1475/2016/JAS on the European Medicines Agency’s handling of the referral procedure relating to human papillomavirus (HPV) vaccines

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  • Case: 1475/2016/JAS
    Opened on 05 Dec 2016 - Decision on 16 Oct 2017
  • Institution(s) concerned: European Medicines Agency

This case concerned how the European Medicines Agency (EMA) carried out a “referral procedure”, which is a procedure to deal with questions relating to medicines already on the market in the EU. The specific referral procedure related to human papillomavirus (HPV) vaccines. HPV vaccines prevent infections with the most common types of HPV, which can cause cervical cancer.

The procedure was conducted by the Pharmacovigilance Risk Assessment Committee (PRAC), which is EMA’s committee responsible for monitoring the safety of medicines on the market. The aim of the procedure was to examine whether there is any evidence of a causal link between HPV vaccination and two syndromes, complex regional pain syndrome (CRPS), a chronic pain condition affecting the limbs, and postural orthostatic tachycardia syndrome (POTS), a condition where the heart rate increases after sitting or standing up, causing symptoms such as dizziness and fainting. PRAC concluded that the evidence did not support a finding that HPV vaccines cause CRPS or POTS. This finding was later confirmed by EMA’s Committee for Medicinal Products for Human Use. The finding is shared by other public health bodies around the world.

The complainants expressed concerns about the handling of the referral procedure, its transparency and openness, and its impartiality. They mainly disagreed with the nature of PRAC’s scientific work.

The European Ombudsman’s Office is not a scientific body. The Ombudsman’s role does not include taking a view on the merits of scientific evaluations carried out by specialised scientific agencies, such as EMA’s assessment of the safety of a medicine.

The Ombudsman may, however, seek to assess whether scientific bodies such as EMA have the necessary procedural safeguards in place to ensure that the examination of scientific evidence is complete and independent, and whether these safeguards have been properly applied in any given procedure.

Following her inquiry into the procedural aspects complained about, the Ombudsman concludes that her inquiry did not identify any procedural issues that could have negatively affected the work and conclusions of PRAC in the referral procedure. The examination of the scientific evidence was complete and it was independent.

Given the importance of ensuring citizens’ trust in the procedures of bodies such as EMA, the Ombudsman suggests that EMA proactively makes public as much information as possible on the scientific work of its committees.

In response to a suggestion made by the Ombudsman during her inquiry, EMA agreed to review the confidentiality requirements on experts so that experts may discuss in public details of the scientific debate once that debate has been completed.

The Ombudsman also suggests that EMA provides more information on the documents of relevance it has in its possession, so that it is easier for citizens to request access to such documents.

Finally, the Ombudsman considers that EMA’s conflict of interest policy was fully complied with during the referral procedure on HPV vaccines. There were no identified conflicts of interest. The procedure in question was therefore deemed to have been conducted in full independence by the relevant scientific experts.

The Ombudsman concludes that there was no maladministration by EMA in the handling of the referral procedure on HPV vaccines.