New European Pharmacovigilance Legislation



Becky Wilcox
03/01/2012

New legislation will be passed soon in Europe that will change the way medical agencies address the issue of pharmacovigilance. This could create a boom in a wide variety of sectors, from careers at  contract research organisations to public healthcare agencies. Pharmacovigilance (PhV) is a widely practiced pharmacological science whose purpose is to identify, understand, and address adverse effects in drugs and medicines. It's primary objectives are to discover medicinal hazards and protect patients from being harmed by them.

In Europe, pharmacovigilance is maintained by the European Medicines Agency and the national competent authorities who combined make up the equivalent of the FDA, pharma manufacturers and non-profits in the U.S. In the new legislation, any patient in the European Member States will be permitted to submit his or her adverse reactions to a drug or medicine. This is being enacted in an attempt to make PhV procedures more transparent and to create a better environment for public conversations on the issue.

The primary changes in the new legislation will accompany the creation of the Pharmacovigilance Risk Assessment Committee. At first the legislation will help to establish post-marketing safety and results management. It will also create to signal detection procedures for new medicines. The chain of priority will run from public health and safety to better communication to revised processes. Overall, it's the biggest change to these laws since 1995.

One of the biggest risks to the new rules will be the possibility of them stilting innovation and competition. Some health experts and industry analysts worry that the new agencies and legislation will create more strict regulations that will prevent pharmaceutical companies from creating new medicines, jobs, and R&D. Members of the European Medicines Agency counter that the legislation will only work to foster better safeguards for public health. Others worry that pharma stocks in the European market will take a hit, prompting the EMA to promise stakeholder consultations.

Other issues in European pharmaceutical law include patent law issues, the blurring line between pharmaceutical products and medical devices, data protection through bio-markers, advanced therapies and drug costs. These considerations come on the heels of what will be an anticipated $50 billion in pharmaceutical revenue loss from patent expirations. This loss will be exacerbated by squeezed healthcare budgets. On the brighter side, financial institutions like JPMorgan expect drug makers' production pipelines to improve and generate more cash. For that reason, by midway through the year, analysts expect investors to look to the near future and expect growth. It's unclear whether these projections will be complicated by the new pharmacovigilance legislation. 

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