Pharma industry issue statement of caution on clinical trial transparency
The European Federation of Pharmaceutical Industries and Associations (EFPIA) has issued a statement warning the European Parliament, European Commission and Council of Ministers not to approach the issue of clinical trial transparency “in an indiscriminate way”.
With the European Commission’s proposals for reform of the Clinical Trials Directive via a new Regulation now under scrutiny in the European Parliament, the industry body has expressed concern that transparency of clinical trial information should be balanced against commercial confidentiality.
The statement follows activity by the British Medical Journal, the Cochrane Collaboration, and health journalists to highlight the need for stronger requirements on full disclosure of clinical trial results, whether positive or negative.
Amongst industry concerns are that publishing certain chemistry, manufacturing and controls as well as non-clinical data following European marketing authorisation could “enhance the ability of non-innovators to obtain approval outside the EU based on the originator’s data”
The European Parliament has now allocated scrutiny responsibilities for the Commission proposals to various Committees with deadlines for Members of the Parliament to table amendments in January and February 2013.
The issue of clinical trial data transparency looks set to remain on the key issues of debate.
EAHP is collaborating with a number of partner organisations in order to ensure the new Clinical Trial Regulation meets the needs of hospital pharmacists in practice, with a new joint statement of interested organisations to published in the coming week.
Recent EFPIA statement here
EAHP statement here
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