Trade Bill — House of Lords, 2018-09-11
Topic: Health
Ajay Kakkar (Crossbench, Unknown): My Lords, I thank the Minister for the thoughtful way in which she introduced her first Bill in this House. I remind noble Lords of my entry in the register of interests as chairman of University College London Partners and Business Ambassador for Healthcare and Life Sciences. I will confine my remarks to Clause 6 of the Bill, dealing with the question of the European medicines regulatory network The life sciences sector is hugely important to our country in terms of both the economy and the broader health of the nation. We are fortunate to be home to two of the world’s top 10 pharmaceutical companies. There are some 5,000 businesses in the life sciences sector, employing some 235,000 people between them. The sector is worth some £68.5 billion a year to the economy. Over the last 20 years, the pharma industry has been a positive net contributor to our nation’s trade surpluses As a result of the expertise in this country, the United Kingdom is the number one destination in the European Union for inward investment in the life sciences sector. Small and medium-sized enterprises—some 3,500 companies—have grown consistently since 2009 at a faster rate than the rest of the economy, and more than 500 of those small and medium-sized enterprises now actively export However, beyond the businesses involved in life sciences, the expertise in our country has resulted in both the development and sustaining of a broader ecosystem. That ecosystem includes four of the top 10 biomedical universities in the world and a series of other university departments, charities, and of course the National Health Service, which are seen as fundamental not only to this sector in our country but fundamental more broadly because of their global contribution In that context your Lordships’ House, on Report of the EU withdrawal Bill on 18 April of this year, heard from my noble friend Lord Patel on an amendment that dealt with the question of clinical trials regulation. Inevitably, in such an important sector that so directly affects the lives of citizens across every European country, there is a degree of important regulation that attends the question of how the database—the research that justifies the introduction of new medicinal products—is conducted. In 2004, the European Union introduced the clinical trials directive. Regrettably, over time that was shown not to be achieving what was intended, and Her Majesty’s Government, among others, led the way in ensuring a revision of that directive, which resulted in the clinical trials regulation of 2014 When considering the withdrawal Bill, Her Majesty’s Government rightly identified that, although the clinical trials regulation had indeed been passed by the European Union, it was yet to be fully adopted because there was a need to establish a central portal for the accumulation of data associated with clinical trials that would be made available across all member states. As a result, the 2014 regulation could not be considered—certainly at the moment we were considering the withdrawal Bill—as retained EU law that would therefore be directly transposed into domestic legislation at the time we left the European Union. That is a very important point because the clinical trials directive has hindered clinical research, particularly in the United Kingdom. The new trials regulation overcomes those problems, and it could have left us in the situation where our country was left with the old directive on statute, governing the way that trials are conducted in the United Kingdom, while the new regulation providing a much better framework would not be, and therefore we would be left in a disadvantaged position The noble Baroness, Lady Goldie, when answering that amendment, which was ultimately withdrawn, gave the assurance that the elements of the clinical trials regulation that could be incorporated by Her Majesty’s Government in domestic legislation would be incorporated to ensure that many of the disadvantages of the directive would be overcome, irrespective of what status the regulation had by way of retained legislation. However, there are two elements that the Government were not able to give an assurance about. The first was the participation of the United Kingdom in the clinical trial portal, which is vital if we are going to participate across the European Union in clinical research in future and vital for ensuring the competitiveness of the life sciences sector in terms of developments and innovations in our own country that could ultimately undergo rigorous clinical trial testing and then be adopted across a substantial market which has very high global standing. Clearly, Her Majesty’s Government were keen for the United Kingdom to participate in that portal but were unable to give the assurance The second element was participation in the single assessment procedure that would result from the new clinical trials regulation, streamlining the way that applications for new medicinal and device products were considered by the European Union—which, again, is vital for market access. When the Trade Bill was considered by the other place, a contested amendment was introduced that resulted in Clause 6, which commits now for every effort to be made to ensure that the United Kingdom participates in the European medicines regulatory network. This is a network comprising the European Commission, each member state’s own regulatory authority for medicinal products and the European Medicines Agency The Minister has said that this is principally a technical and pragmatic Bill, and therefore I have a couple of technical points to put to her. The first is this: does Her Majesty’s Government believe that this clause and, therefore, the European medicines regulatory network, provide the vehicle by which they will be able to pursue the big questions they were unable to deal with in terms of considering the clinical trials regulation—that is, participation in the research portal and the question of participation in the single assessment procedure? Secondly, if this is to be the vehicle, can we be clear that the Government feel it is the mechanism by which they will now deliver on the commitment they made on Report in the withdrawal Bill, which resulted in that particular amendment not being voted on Finally, I would like to understand a little more about how the Government propose to use this commitment to participation in the European medicines regulatory network to take forward broader opportunities for securing the life sciences base in our country.