Health: Medical Innovation

Baroness Morgan of Drefelin Excerpts

Wednesday 16th January 2013 Lords Chamber

[Baroness Morgan of Drefelin]

My Lords, I congratulate the noble Lord, Lord Saatchi, on securing this debate. I, too, found his introduction moving, so I thank him for that.

I declare an interest as chief executive of the medical research charity Breast Cancer Campaign and, perhaps more importantly for this debate, honorary president of Cancer52, an alliance of more than 60 organisations—many of which are very small and unstaffed—working to address the issues faced by those with less common cancers who make up 52% of UK cancer deaths, including ovarian cancer.

The promotion of a vibrant research environment is absolutely essential for the development, evaluation and take-up of new medical innovations in our NHS. Research and innovation are vital if we are to ensure better outcomes for cancer patients, which is why I am so proud that we in this House worked hard and successfully to ensure that duties to promote research and innovation were included in the Health and Social Care Act 2012. It is now equally essential to make sure that these duties are embraced by the new NHS structures as they take up their responsibilities in the coming months. I know that there is much debate about how that will happen.

I turn to an issue that is of concern to many patients: the use of drugs which are off-patent and not licensed for a particular indication, but which could be helpful in new and innovative ways. This is a little related to concerns that the noble Lord, Lord Saatchi, has raised through his Private Member’s Bill. Many noble Lords will have seen the news yesterday about proposals from the National Institute for Health and Clinical Excellence to recommend the use of the drugs tamoxifen and raloxifene for the prevention of breast cancer in high-risk patients. The barrier to using tamoxifen for chemoprevention in the UK arises from the fact that the drug is now off-patent and its original licence does not cover the use of tamoxifen for chemopreventive purposes, despite the drug being licensed for this indication in the United States for a number of years. Because existing UK legislation only allows the original owner of the drug to seek to change the indication—even when a drug is off-patent and there is therefore no incentive for the drug company to seek a change at this stage—this means that medical professionals who may wish to prescribe the drug for their patients must do so outside the existing licensing agreement. This is a significant disincentive and we could argue that it is stifling innovation.

Indeed, the draft guidelines issued by NICE yesterday are clear. They state that the prescriber of these drugs should follow the General Medical Council’s good practice in prescribing medicines and take full responsibility for their decision. This means that medical professionals must clearly document that the patient, or whoever has the authority to give consent on the patient’s behalf, has provided informed consent to receive the drugs for chemopreventive purposes.

Although the NICE guidelines are designed to circumvent this problem and make health professionals more comfortable with prescribing these particular drugs for chemoprevention, the best way to eliminate any remaining doubts for prescribers would be for a new avenue to obtain licences for new indications for drugs where there is a clear evidence base of clinical benefit and when they are off-patent. Therefore, would the Minister tell us what avenues the Government are exploring for closing this existing shortfall in the current legislation? Have the Government perhaps explored any possibilities for public bodies such as NICE to seek new licences for off-patent drugs where the manufacturer has no incentive to do so? He might want to write to me on this, but it would be very interesting to hear how this kind of innovation—which is looking at existing medicines and discovering how they might be used in different ways in different conditions —could be made a more nimble, innovative process.