EU publishes new drafts of patient information and pharmacovigilance proposals

March 8, 2012

The European Commission has published the revised proposals on pharmacovigilance and information to patients, following its decision on 2 December last year to separate the two. The two proposals, which each take the form of a draft directive and draft regulation, have now been sent to the European Parliament.

The pharmacovigilance proposals had been piggybacked onto the patient information draft in October 2011, but it soon became clear that this was not a good idea, because the pharmacovigilance part will complement the major body of drug safety legislation that is due to come into effect in July this year and so needs to be approved quickly. Getting the controversial patient information proposals through the legislative process is likely to take much longer.

The commission said that the splitting of the proposals into four separate texts was “a purely technical separation” and that the actual wording of the two proposals was unchanged from the versions adopted in October.

The new pharmacovigilance provisions were drafted in light of the regulatory failings that led to the French Mediator affair. “Following an analysis of the Mediator case in the light of the 2010 pharmacovigilance legislation (“stress test”), the commission has detected certain weaknesses in the pharmacovigilance system which should be addressed,” it said.

The draft puts forward a number of new provisions. For example, if a product is no longer to be marketed, either temporarily or permanently, the company must notify the authorities no less than two months before supply is interrupted, and will have to explain the reasons for such action.

Approved drugs that are subject to special surveillance by national authorities will be included in a publicly available list that will include an electronic link to the product information and the summary of the risk management plan. Products on the list will include the statement “This medicinal product is subject to additional monitoring.”

The controversial patient information proposal would allow pharmaceutical companies to provide a limited amount of information to the public on their prescription medicines. It was heavily amended by the parliament, and the commission has revised the draft to reflect most of these amendments.

For instance, it clarifies what information companies “should” make available and what they “may” make available, lays out the criteria that such information should meet, and allows for pre-vetting of information before it is made available.

Previous post:

Next post: