Pharma worried by drug safety monitoring costs

Groups covering the pharma, biotech and generics industries have come together to raise their concerns about the growing cost of monitoring drug safety in Europe.

A total of five associations, including Europe’s pharmaceutical industry association EFPIA say that regulatory fees have grown rapidly since the introduction of new pharmacovigilance laws in 2010.

In addition to EFPIA, the statement has been signed by: European Generic medicines Association (EGA) European biotech industry (EuropaBio); Association of the European Self-Medication Industry (AESGP), and the European Confederation of Pharmaceutical Entrepreneurs (EUCOPE).

New, tougher EU pharmacovigilance laws were introduced in 2012 in order to help identify safety problems with medicines already on the market. The laws were introduced following numerous specific safety controversies, including that around GSK’s diabetes drug Avandia. Whilst the laws were being drafted, the safety scandal surrounding Servier’s Mediator emerged, resulting in further additional safeguards added to the regulations.

The introduction of fees to pay for this increased pharmacovigilance was unpopular with the industry from the outset, but now the groups say procedural fees, such as for pharmacovigilance referrals, have been significantly increased compared to the Commission’s initial calculations. They add that there has been no ‘open and transparent communication’ to alert them to costs needing to rise.

The five industry groups say the EMA and each of the EU’s national medicines regulators should help cover some of the costs, as they say this is what was intended in original legislation.

A strategic review of the system of how the European Medicines Agency charges fees to medicinal products sector is expected this year, and the healthcare industry says this is an ideal opportunity to reconsider how pharmacovigilance is paid for.

The groups are calling for EU decision-makers to present annual cost breakdowns and detailed information on performance indicators for the activities covered by the fees regime. They want to see a financial overview, including the pharmacovigilance costs at the European and national levels (including national annual fees and safety related variations), in order to come to a European-wide picture.

The group concluded that they wanted to establish a dialogue with regulators and payers to ensure that the system is “firmly based on the principles of cost-effectiveness, fairness, proportionality and transparency.”


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