Drug Companies: Medical Trials

Baroness Brinton Excerpts

Monday 24th February 2014 Lords Chamber

[Earl Howe]

My Lords, during the course of last year, the Government gave detailed evidence to the Science and Technology Committee on the issue of data provision in respect of clinical trials. The committee made a number of helpful recommendations on the removal of barriers to transparency. In our formal response, we set out how we would work to achieve the aims of greater transparency. In the light of that response, the Government are looking into the recommendations of the PAC report on the stockpiling of Tamiflu and access to clinical trials data, published in January. We will give our formal response to the report next month.

[Baroness Brinton (LD)]

My Lords, evidence shows that the chances of a complete trial being published are roughly 50%. The recent EU clinical trials draft directive will require all trials to be registered before they start, and full results to be published within a year. However, the regulation will be applicable only to trials starting from this year. How do the Government plan to ensure that pharmaceutical companies will release medical records for drugs that were launched before 2014?

[Earl Howe]

My noble friend raises a topical question. The industry’s trade body, the Association of the British Pharmaceutical Industry made clear, in its code of practice in 2012, that companies are obliged to publish all clinical trial results within a year of marketing authorisation and publicly register new clinical trials within 21 days of the first patient being enrolled. That, of course, is a forward-looking exhortation, but we are encouraged by the fact that the industry is taking an increasingly responsible view in this area by publishing data voluntarily, as demonstrated by companies such as GSK, AstraZeneca and Johnson & Johnson. We want to encourage more companies to do the same.