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.
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?
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.
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?
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.
The noble Earl has made very clear the legal background to the present situation. He is fully aware that if a drug that has been fully tested and shown to be highly effective, and NICE has recommended that it should be prescribed to patients, the authorities have the legal responsibility to prescribe it. If, on the other hand, NICE has been given evidence to indicate that a particular remedy is ineffective as a result of negative clinical trials, is it equally incumbent on health authorities to recommend that that drug should not be prescribed?
Certainly, my Lords, any advice that comes from NICE on the clinical effectiveness of a drug should be adhered to by commissioners. It is not, however, mandatory that that happens. Commissioners have discretion in that area.
I compliment my noble friend on the full and comprehensive Answer that he gave to the Question, and on the reassurance that it contained. Do he and his colleagues think that perhaps the issue here is not the legal framework but the issue of transparency and ease of access to information? If they think that that has some merit, would they be willing to consider having a simplified summary of the legal position on the department’s website for easy access for those who are interested?
I absolutely agree with my noble friend. The Government are committed to transparency in the area of clinical trials. Transparency is important for patients, the public, researchers and the NHS, and it can be achieved through ensuring trial registration and outcome publication, as well as making data available through the appropriate channels. I think that the new EU regulation will be extremely helpful in promoting transparency, and the availability of summaries of all trials and clinical study reports will be a part of that regulation. However, I take my noble friend’s point about a simple guide for the public and I will gladly consider it.
My Lords, will the Minister confirm that the work put in hand by the previous Government to ensure that we had the capacity to produce sufficient quantities of drugs to counteract various types of bird flu, once it had been identified, has now been completed and that we are in a position to be able to do that?
My Lords, I readily acknowledge the work done by the previous Government, which makes this country probably the best prepared in the world for a flu pandemic.
My Lords, I come back to the question raised by the noble Baroness, Lady Brinton. Once a medicine goes off patent it can, through generic production, remain available to members of the public for many years. The evidence seems to be that trials that give a favourable verdict are twice as likely to be published as trials giving unfavourable results. Could the noble Earl focus a little more on whether the industry can be encouraged to produce evidence around those trials in relation to current medicines as well as future ones? I also refer noble Lords to my health interest in the register.
My Lords, it is important to point out that the MHRA does not have evidence that there is systematic or large-scale withholding of data. However, it has investigated cases in the past where clinical trials and safety data were not properly reported. The Government believe that the proposals included in the new EU clinical trials regulation will, as I said, contribute to greater transparency in the area of clinical trials. It must be remembered that any company infringing even the current rules can lay itself open to some very severe penalties.