Safety of Medicines and Medical Devices

Lord Suri Excerpts

Thursday 28th February 2019 Lords Chamber

[Lord Suri (Con)]

My Lords, I am very pleased to participate in today’s debate and privileged to have heard the maiden speech of the noble Lord, Lord Carrington, who brings the wealth of knowledge of senior Carringtons to this House. The debate is of great importance to all of us here, and serves as one of the most pressing cautionary tales for what might happen if the other place does not pass the withdrawal agreement that will be coming before it in due course.

The safety of medical devices and medicines is not a present issue in the minds of the electorate and does not get the attention it deserves. Part of this is down to the incredible luck we all have to live in a country with an excellent health service which guarantees consistently strong treatment across all of its hospitals and surgeries, with investment decisions taken after thorough consultation and planning. We are particularly lucky to have a national regulator with great depth of expertise in particular fields of treatment and medicines—from toothpaste to gene therapy. It is a great shame that, post-departure, the likelihood of the MHRA receiving commissions from the EMA will considerably diminish. One-third of the income of the MHRA is linked to EMA funding, and unless government support is guaranteed there is a serious and pressing risk that the MHRA will suffer a loss of income and reputation and an outflow of specialists to other European regulatory agencies, taking a sizeable proportion of the UK’s comparative advantage with them.

This is important, as it underpins investment by pharmaceutical firms in our universities and labs. It is natural that they would be keen to be close to the leading researchers and benefit from their expertise throughout the development process. I therefore ask the Minister to confirm ongoing government support for areas of specialist research traditionally funded by the EMA for the MHRA, such that the UK maintains our lead in the areas in which we excel. If this cannot be guaranteed, will the Minister commit to seeking a close continuation of the existing relationship in the next stage of Brexit talks focusing on the future relationship? I also wish to add my approval of the ongoing Cumberlege review. The NHS is funded out of general taxation to serve the population, and it is of paramount importance that the people’s voices are heard as soon as concerns are raised about medicines or medical devices.

Too often in the past we have relied on clinicians raising concerns with NICE or the MHRA and then letting action be taken, even when there has been a substantial degree of concern in the patient community. A great deal can be learned from the mechanisms enshrined in statute in Section 11 of the Enterprise Act. So-called super-complaints allow representative consumer bodies to make a well-researched complaint about some feature of the market, to which the responsible regulator or a Minister must respond within a given timeframe. The principle was extended to financial markets by the Financial Services and Markets Act 2000, and the mechanism operating via both of these statutes has been endorsed by consumers and industry alike as an effective means of ensuring accountability and maintaining high standards. I know, of course, that the yellow card scheme operates in a similar way, but there is no guarantee of a fast-track process for responsible nominated groups operating on behalf of consumers. Having had the advantage of reading some of the submissions made to the review online, I have been impressed with the quality of submissions made to the group and I therefore think that they should be given super-complaint powers.