EU pushes ahead with pharmacovigilance reforms
2010 laws may not have provided sufficient protection
The European Commission (EC) has proposed four new pieces of legislation to promote better monitoring of medicine manufacture: a European Union (EU) regulation and directive on pharmacovigilance and a regulation and directive on information to patients.
They have been drafted following a pledge from health commissioner John Dalli to simplify proposals released last October, which attempted to force new patient information and pharmacovigilance rules into two laws – a directive (which gives EU member states some discretion over implementation) and a regulation (which does not).
‘The split of the proposals aims to facilitate the discussion of the proposals by the co-legislators…the European Parliament and the Council of Ministers,’ said the EC.
The reforms are an admission that the 2010 laws may not have provided sufficient protection against bad medicine. One area of concern addresses the need for automatic EU safety reviews of pharmaceuticals withdrawn from sale in one member state. Another is that pharmaceutical companies do not have to declare reasons for withdrawing a product themselves.
‘It cannot be ruled out that voluntary withdrawal of a marketing authorisation or product…could lead to safety issues being missed, in particular if the company is not transparent about possible safety concerns,’ said the EC.
The latest proposals come as Brussels has released a series of detailed responses written by EU pharma industry associations and companies to questions posed by the EC as it considered reforms to the EU’s pharmacovigilance (PV) system. This included whether additional processes and pharmacovigilance tasks should be covered in PV system master files. The Association of the British Pharmaceutical Industry (abpi) and the European Federation of Pharmaceutical Industries and Associations (EFPIA) answered this in the negative.
See http://ec.europa.eu/health/human-use/pharmacovigilance/developments/pc_perf_pharmvig_2011_en.htm
Meanwhile, the European Medicines Agency (EMA) has been preparing for the introduction of the 2010 pharmacovigilance laws, which come into force in July. It is setting up a new pharmacovigilance risk assessment committee (PRAC), which first meets on 19 July. An EMA note said the agency would inform the pharma sector ‘through its website and...meetings’.
The EC has also released information about the reform process – see http://ec.europa.eu/health/human-use/pharmacovigilance/index_en.htm