My Lords, I have a personal interest in this most important Bill, as medicines have saved my life on several occasions, and I use several medical devices. But most important to me is the safety of our country in this difficult time of coronavirus and leaving the EU.
The Secretary of State has an immense responsibility in providing safe functions relating to medicines for humans and animals and to medical devices. Leaving the EU means that we will not have the advantage of voting at the European Medicines Agency, where we were among the leaders, and it puts extra stresses and strains on our MHRA. The MHRA works so well with the European Medicines Agency, which has now moved from London to Amsterdam. I ask the Minister: will the MHRA be given more support and funds to carry out its extra and vital work? What will happen with clinical trials in the UK, which are based on the EU clinical trials directive and operate through the MHRA? It is not expected to apply in the EU until after the end of the transition period. This means it will not be part of the EU law, so what will the UK do about this important matter? My noble friend Lord Kakkar also stressed this.
Thousands of clinical trials seeking new treatments for diseases, including cancer, heart disease and many rare conditions, have been suspended or abandoned in the wake of the Covid-19 pandemic. Charities that raise money to provide funds have lost millions of pounds in revenue that would go a long way to helping to research new medicines and therapies that are desperately needed. Coronavirus has cast a shadow across the world. We should work together to fight this disease. But the emphasis on the attractiveness of the UK to conduct clinical trials or develop medical devices must not be put before patient and user safety.
The Bill covers so many aspects of safety. I have been involved with the disaster of sodium valproate, the drug given to pregnant women with epilepsy; their children were born with autism. I hope that the recommendations of the Cumberlege report will be accepted, especially the creation of the post of patient commissioner. I am pleased that the Bill addresses the dangers of falsified medicines. However, the Company Chemists’ Association would like to avoid the unintended consequences of data being used for purposes other than to ensure that medicines are safe. It is asking for “any purpose” to be amended to “in agreed framework”.
Everyone to whom I have spoken agrees that we should maintain the highest possible standards of patient and animal safety. I hope that we can work globally and not become isolated.
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