EMA Pushes for Release of Clinical Trial Information
The European Medicines Agency (EMA) readies itself to battle lawsuits from two pharmaceutical companies as the agency attempts to make more clinical trial information publicly available.
EMA Pushes for Drug Trial Transparency
- According to Reuters, leaders of the European Medicines Agency have reported that its agency intends to release information on drugs, two of which are being sold by two U.S. drug makers whom are taking legal action.
- The agency has been at odds with much of the drug industry over this push for transparency through their decision to release confidential trial information that drug makers submitted in the application process to get their medicine on the market.
- Researchers and patient consumers alike feel that access to this data will improve the process of third-party scrutiny and stress-testing. Drug companies, however, are protesting the release of data for fears that it will undermine the protection of patents and harm their business.
- The EMA Executive Director contends that the fears that these companies have expressed are misplaced. Rather, releasing this data would help the company’s scientist searching for new drugs to add to their products.
- A main legal concern that drug companies have is that the release of data will infringe upon the protection of their patents because the information on drug trials will be available to other companies who can avert the research process themselves.
- The drug companies AbbVie and InterMune have legally challenged the EMA’s new policy. The companies received and interim decision that prohibits the EMA from releasing the data.
- The final decision is still pending and the EMA has applied to have the injunction removed and has filed an appeal that was heard this month. A final court decision is still being made.
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