My Lords, my two colleagues have made a powerful case for the European Medicines Agency. They are perfectly right. The consequences of getting rid of it—of leaving the EU structure—are very serious. There are two parties involved in any introduction of a new ethical compound to the market. One is a pharmaceutical major—and by “major” I mean household names that the House will be familiar with: Pfizer, Merck, Eli Lilly, AstraZeneca, Glaxo, Boehringer, Bayer, Sanofi, Roche—I have left out two or three and a couple of Japanese ones, but you can count them on the fingers of three hands or so. The second is a regulatory agency that provides registration, which is of course the key to licensing, prescribing and selling freely a drug in the jurisdiction concerned.
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People who know a lot about this subject may be surprised that I have not mentioned smaller pharmaceutical boutiques, because it is well known that most new drug registrations in the past 20 years have been for compounds identified and developed in small boutique companies. However, those companies never get involved in the registration process. They cannot possibly afford it. The registration of a new compound typically costs about £1 billion a throw. The clinical trials that must be randomised and which
last for years are particularly expensive. No boutique can face that; nor will a boutique have the resources to market a drug. Those two roles remain in the hands of the pharmaceutical majors.
All that is necessary to understand what might happen if we leave the European Medicines Agency. The Government will have four choices if we do. The first is to do nothing at all, which would have the consequence of new compounds not being registered in this country. They would not be available for prescription and British patients would not have them. I assume that the Government will exclude that possibility. The noble Lord, Lord Warner, suggested another possibility: building up the domestic registration agency, perhaps along the lines of the European Medicines Agency or the FDA in the United States, and opening it for business. I am prepared to predict that that new agency would go broke within 12 months. It would not get any customers because pharmaceutical majors that have already spent £1 billion getting registration for the European Union or the United States will not want to spend another £1 billion going through registration for a country that has a mere 3% of the sales of ethical pharmaceutical products. They would not use it.
I suppose that the Government could decide to set up an agency with softer criteria, less demanding rules and lower registration costs, and attract business in that way. I think it inconceivable that any reputable scientist in this country—we have wonderful scientists in pharmacology, biochemistry and, of course, medicine —would agree to work on that basis and to give up the professional standards for which they are famous. At that point, the only thing that the Government could do would be to act as a kind of passenger on the system and say, “Well, if a drug has been registered by a reputable registration agency in, say, the United States or the European Union, we will just follow that”, and, without any procedures at all, allow that particular drug to be marketed in this country. That would also be an extraordinary move on the part of a country that has played such a major role in drug registration in the past. Surely it would be an extraordinary result for a Government concerned about national sovereignty if we became entirely dependent on an organisation over which we have no influence whatever, as we would no longer be involved in its management structure or its strategic thinking. That would be very bad news.
The purpose of my intervention is quite simple: to ask the Government what they would do if they left the European Medicines Agency at the same time as they left the European Union, which is quite unnecessary. As far as I know, there is no basis for expelling a member. I do not think that there is any political interest in trying to expel the United Kingdom, anyway. So we would have to take the initiative and resign, if we wished to resign. Equally, we could do nothing and remain part of the European Medicines Agency, with all the advantages that my two colleagues have set out this evening.