Safety of Medicines and Medical Devices — House of Lords, 2019-02-28
Topic: Other
Rupert Carington (Crossbench, Unknown): My Lords, in 1797 my four times great grandfather, the banker Robert Smith, was introduced to the House of Lords on the recommendation of William Pitt—that is, Pitt the Younger—to King George III. The result was that a goodly proportion of the House walked out because he was the first person in trade to be elected to your Lordships’ House. I can only hope I do not stir the same reaction I am really privileged to be here today making my maiden speech. Like others, I have sat quietly for some weeks observing the workings and customs of the House. I cannot say that I am yet confident about every aspect of being a newly minted Peer, although I have received endless help and attention, from the doorkeepers up to the Convenor of the Cross Benches, from the attendants up to Black Rod and, of course, from my mentor, my noble friend Lord Aberdare. I have also received help from Peers from every side of the House Furthermore, I am most grateful for the splendid services available to Peers, in particular, for the incomparable Library which magicked up a copy of my father’s first speech in your Lordships’ House. I fear this was not very helpful, as he did not make a maiden speech but instead asked an Oral Question—God forbid! The subject was the use of prisoners of war on farms, as they accounted for 40% of farm labour in 1945. I doubt that that is the solution to current agricultural employment issues. Many noble Lords knew my father, and it is therefore a frightening experience to follow in his huge footprints As for myself, because of my father’s political presence, I decided to follow a different career path, which I hope has given me sufficient experience in a number of areas to enable me to contribute to the work of this House. I am a banker by way of background, specialising in the world of investment, both direct and portfolio, and I still pursue this career as an independent adviser. I have lived in Asia and travelled widely. I have also worked in the Middle East and have been involved in Saudi Arabia since 1974. Currently, I sit on boards and have advisory appointments in the United States, Europe, the Middle East and the Far East. At home in England, I am an active farmer and a lover of the arts. I am privileged to be a governor of the Royal Shakespeare Company I thank the noble Lord, Lord O’Shaughnessy, for introducing this debate. Although I cannot claim to be an expert in the detailed subject of the safety of medicines and medical devices, I am fairly conversant with the importance of the regulatory aspects of the factors which govern the overall environment in which healthcare is brought to the general public. The patient safety aspect of medicine and medical devices is paramount and is constantly evolving with the assistance of new technology, innovation, data capture and identifying worldwide best practice. I am pleased to note that the independent medicines and medical devices safety review is under way and will bring invaluable recommendations to the Government I would, however, like to raise a broader issue which needs to be borne in mind throughout our deliberations, since healthcare accounts for some 10% of gross domestic product. In order to satisfy all patients, the provision of healthcare needs to be driven by innovation, demand, affordability and government regulations. The challenge for regulators worldwide, whether the European Medicines Agency, our own MHRA or, in the US, the Food and Drug Administration is to facilitate innovation without lowering standards. Whether we are in Europe or outside, the same issues arise. Innovation enables new, more efficient medicines and devices to be brought to patients at a more affordable cost. It is important that, while not compromising on safety, regulations do not inadvertently inhibit the all-important innovation In a small way, I have been involved in the analysis of a number of healthcare companies, particularly in the United States. Over the years, therefore, I have had cause to study the workings of the US FDA which, for many innovators, was seen as a regulatory roadblock. This has changed since the current commissioner took over; unusually in today’s environment, he is thought of positively on both sides of the US political divide. The FDA is now collaborating with companies in a more proactive way during the development process. It is offering more guidance and engaging in more interactive exchanges with companies prior to filings The importance of an innovation-friendly regulator cannot be overstated when the results are new products coming to the healthcare industry at a rapid pace, enabling patients to benefit faster than ever before. This is demonstrated by a 168% rise in drug approvals between 2016 and 2018 in the United States. There has been a similar improvement in the approval of medical devices. The regulation of medical devices differs from that of drugs, but the end goal of both approaches is the same: to ensure patient safety and performance. I would be interested to hear from the Minister whether the MHRA has been following these exciting developments at the FDA, and whether there is a process in place to learn from them The purpose of bringing these experiences of the FDA to your Lordships’ attention is to demonstrate the value of adopting best practice in the overall field of healthcare, from innovation to manufacture and delivery to safety. The FDA has its issues, and no doubt follows carefully the work of the EMA and MHRA, but I would urge that, in a field where the overall interests of patients are paramount, we can all learn from each other. Will the Minister please assure us that the principal regulators worldwide are communicating regularly and closely to achieve this essential balance between safety and innovation?