Medicines Regulation

Debate between Helen Goodman and Philippa Whitford

Tuesday 21st November 2017 Westminster Hall

[Helen Goodman]

The hon. Gentleman truly is a gentleman, and I agree with him entirely. We want to see continued UK participation in EU regulatory and medicine safety processes as well. The ABPI has also said, reasonably enough, that it wants to maintain trading terms equivalent to being a full member of the customs union, and to have a common system for VAT.

In May, the EMA and the European Commission issued a statement saying that if the United Kingdom does not stay in the single market, stick with the EMA, or join the EEA—the European economic area—but goes for a clean break, drugs made in the United Kingdom will no longer be authorised for use in the European Union, and drugs made in the European Union will no longer be authorised for use in the UK. Tackling that would involve costly and time-consuming checks. It could even mean that the availability of drugs would diminish dramatically.

What response have the Government made to that statement? What practical steps have Ministers taken? All we have seen is a letter from the Secretary of State for Health and the Secretary of State for Business, Energy and Industrial Strategy to a newspaper, which said that they want a “close working relationship” with the EU, and that patient safety matters, as does certainty, long-term stability, and innovation. The letter said that Ministers will set up a regulatory system with competitive fee pricing. This afternoon, we would like the Minister to explain that.

Currently, the UK Medicines and Healthcare Products Regulatory Agency—MHRA—contributes to the EMA’s work, and the UK pays approximately a fifth of the overall costs. It is universally acknowledged that the MHRA could not take on the task of licensing all drugs without astronomical costs for the industry and the taxpayer.

[Dr Philippa Whitford (Central Ayrshire) (SNP)]

Is part of the problem not that there appears not to have been a specific assessment of all the health-related impacts of leaving the EU?

[Helen Goodman]

I agree entirely. We tabled amendments when the article 50 legislation went through requesting impact assessments on many things, including the effect of possibly leaving the EMA, and we have not heard about them. That is extremely alarming, because it gives the impression that Ministers are basing decisions not on fact and analysis, but on prejudice and assertion—not a very good basis when it comes to health or economics.

This issue matters because life sciences and pharmaceuticals is one of the UK’s most successful industries. The combination of first-class scientific research in our universities and high-quality manufacturing means that we have been exceptionally successful. The life sciences employ 220,000 people—of which pharmaceuticals accounts for 90,000—in good quality, well-paying jobs. They are careers, not gigs. The industry is innovative and internationally competitive. In fact, it has the highest manufacturing gross value added, which means that every employee contributes £330,000 to the British economy every year. The value of our exports is £30 billion. Obviously, the industry wants to continue in those collaborations and develop new medicines.

One of the major costs in pharmaceuticals is research and development; another is complying with regulations. Inspections take several days, and internationally there are two dominant regulators: the EMA, which looks at about a quarter of all drugs globally, and the American FDA, which looks at about a third. Clearly, we do not want regulatory complexity, because that would simply add to costs. As Andrew Witty, the former head of Glaxo said, when the regulatory systems of 27 European countries were unified into one, that was a big deal.

Ministers need to keep in mind that the pharmaceutical industry is international and highly mobile. There is world-class production in France, Switzerland and America, and generics are made across the globe, in China and India. Senior executives answer to their shareholders; if it is cheaper to move, they will, so we need to do everything we can to keep costs down in this country. Quite honestly, I cannot understand why Ministers do not just commit to staying in the EMA—it is so obviously the cheapest and simplest solution—but their crazy ideological obsession with escaping the European Court of Justice means, to quote the Secretary of State for Brexit, “putting politics above prosperity”.

What is even worse is that Ministers are cutting across their own stated principles and are creating a highly uncertain environment. Business needs certainty to invest. For example, in my constituency, a new production facility was started a year ago. It will cost £120 million and will take four years to come into production. We are now only 16 months away from 1 April 2019, but yesterday, AstraZeneca wrote to Members of Parliament to say that it needs a transition period of two to three years.

The Prime Minister made things worse—I do not think she intended to, but she undoubtedly did—when, in her Florence speech, she said there would be a transition period. Everybody imagined that there would be time to look at what the post-Brexit regime would be, to have clear negotiations and to make a plan—to go through everything in a systematic way. Her insistence on putting the March date into legislation shrank that time overnight, from 40 months to 16 months.

Industry is taking decisions now. One plant has already closed in Southampton. GSK is implementing its contingency plans nationally, which include relocating some members of staff to other European Union countries. In Barnard Castle and Ulverston, it is reviewing the production of cephalosporins, which my hon. Friend the Member for Barrow and Furness (John Woodcock) will talk more about later in the debate.

But this is not just about jobs; it is also about health. Every month, the United Kingdom sends 45 million medicine packets to Europe and we receive 37 million medicine packets from Europe. Some 80 million people need those medicines. Border delays in the medical supply chain will affect not just the final product but intermediate production, especially where we are talking about time and temperature-sensitive drugs, such as for cell and gene therapy. More than 2,600 final products have some stage of manufacture in the UK. Delays as they cross the border during production could mean the loss of lives. That is why the Association of the British Pharmaceutical Industry and its European counterparts wrote a joint letter to Monsieur Barnier, the European negotiator, and the Brexit Secretary of State, to sort this out promptly. Ministers should put patients and public health first, and should start co-operating with the European Union on solving this problem. Given the long lead times, they need to speed up the work and sort out the transition phase.

I have seven questions for the Minister. Will he rule out introducing a freestanding, new, regulatory structure? Will he rule out incorporating the MHRA into the American FDA? Will he confirm the Government’s stated aim of keeping British regulation aligned with the EMA’s European regulation? Will he tell us what moving the EMA and setting up a new regime will cost? Will he set out the legal basis for our continued co-operation and participation in the EMA system from 1 April 2019? Will he say how he intends to legislate? And will he commit to more than another 90-minute debate on an affirmative statutory instrument? If he cannot even do that, half of the debating time that Parliament will have on this important subject will be this afternoon.