Drug Companies: Medical Trials

Lord Kennedy of Southwark Excerpts

Monday 24th February 2014 Lords Chamber

Asked by

[Lord Kennedy of Southwark]

To ask Her Majesty’s Government what action they intend to take in respect of drug companies that withhold the results of medical trials.

[The Parliamentary Under-Secretary of State, Department of Health (Earl Howe) (Con)]

My Lords, companies are legally required through the marketing authorisation application process to provide the relevant regulatory authority with all information for evaluation of a medicine. This includes clinical trial results which are both favourable and unfavourable. The Medicines and Healthcare products Regulatory Agency has powers to take action where particulars supporting an application are incorrect or where the company has failed to inform authorities of new information that would influence the evaluation of the benefits and risks of the product.

[Lord Kennedy of Southwark (Lab)]

My Lords, the number 1 risk on the Government’s national risk assessment for civil emergencies, ahead of both coastal flooding and a major terrorist incident, is that of pandemic influenza. Is the noble Lord concerned that Tamiflu, which is supplied for use in a flu epidemic, may not be as effective as was once thought? Is he concerned that many large-scale trials of Tamiflu have not been publicly reported?

[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.