European Medicines Agency

Sarah Wollaston Excerpts

Wednesday 12th October 2016 Westminster Hall

[Daniel Zeichner]

My hon. Friend pre-empts the points that I will move on to. The issue of delay is really important.

I was talking about the option of staying within the European economic area. Sadly, from what we are hearing, and from what is possibly happening in the Chamber at this very moment, that is an option the Government do not seem to be entertaining. If we do not, pharmaceutical companies might have to apply separately to the UK’s MHRA if they want to supply a drug in the UK, as my hon. Friend has pointed out. Most commentators predict that that is likely to lead to a slower, less efficient regulatory process.

The Association of Medical Research Charities has pointed out that the strong and aligned medicines regulation across the EU, underpinned by science, is essential to bringing new medicines to patients in a way that minimises delay and costs. At the weekend, the chief executive of AstraZeneca made exactly that point—that, without the EMA, NHS patients would get new drugs more slowly and drug costs to the NHS would rise, meaning less money for the NHS; not quite what was written on the bus. Perhaps the Minister will confirm that the Government believe that people voted for less money for the NHS. That is certainly not the general understanding.

There is also an associated worry that smaller biotech companies, the lifeblood of our future prosperity, which in many cases are pioneering revolutionary treatments, will lack the capacity to file multiple applications at once and to handle all the associated paperwork. Some will struggle on, and we wish them every success, but I fear others will go elsewhere, to our detriment.

The MHRA finds itself in a potentially difficult place. It has commented, carefully, in response to the referendum result:

“We will continue to work to the highest levels of excellence and quality, working with and supporting our customers, partners and stakeholders to protect health and improve lives. Working closely with government, we will consider the implications for the work of the Agency. We will continue to make a major contribution globally to improving public health through the effective regulation of medicines and medical devices, underpinned by science and research.”

Those words, and the intention behind them, are encouraging, if unsurprising, but the MHRA has been put in a difficult and uncertain position. No major member state has left the EU before, so there is no model to follow for disentangling the UK’s medicines and life science industry from the EMA. The EMA and the MHRA work symbiotically and their separation is likely to be complex. The MHRA may be left with a bigger workload, and pharmaceutical developers may well prioritise the much larger EU market and delay securing regulatory approval in the UK. Indeed, US and Japanese companies already file in their home markets first before seeking approval in the European economic area. The UK, with its much smaller market, will be in danger of being at the back of the queue.

As we have heard, the EMA has allowed UK patients faster access to new treatments. It is worth noting that, in Australia and Canada, where medicines are licensed nationally, patients have slower access. On average, new medicines come to market six to 12 months later than in the US and the European Union. It seems likely we will be in the same position. Is that really what people voted for—longer delays in getting life-saving treatments? Again, I seek the Minister’s view.

The damage is not only done to us. The BioIndustry Association warns that, without Britain, the European Medicines Agency could also end up losing out. It would sorely miss the MHRA’s strengths in patient safety regulation. The Association of the British Pharmaceutical Industry has said that European colleagues are desperate for the MHRA to be retained as part of the regulatory process, owing to the high regard in which it is held. Both the ABPI and the Association of Medical Research Charities advocate ongoing regulatory co-operation between the EMA and the MHRA. The ABPI suggests that there is a strong rationale for seeking regulatory co-operation on the basis of the public health benefits to patients. The organisation says that strong, globally aligned medicines regulation has proven effective in bringing new medicines to patients quickly, without the additional costs of multiple regulatory systems. I believe we should do all we can to safeguard that.

The Government wrote in July that their renegotiation on the new European Union-United Kingdom relationship includes looking at the relationship between the UK and the EU medicines regulatory framework. I would appreciate an update on what they now believe that new relationship might look like and whether regulatory co-operation might still be possible.

[Dr Sarah Wollaston (Totnes) (Con)]

The hon. Gentleman is making a powerful case. These points were raised with the Select Committee on Health in the run-up to the referendum. Will he join me in calling for people to submit further evidence to the Health Committee, now that we have launched our inquiry into what the Government’s priorities should be during their negotiations on the terms of our withdrawal?

[Daniel Zeichner]

I thank the Chair of the Health Committee for her intervention. I certainly encourage those in my area and others to take up that offer. We will be doing so.

Let me come to the most tangible issue of all: the future physical location of the European Medicines Agency. Just last month, the Government said in a written answer to my hon. Friend the Member for Denton and Reddish (Andrew Gwynne):

“The future arrangements which apply in relation to European Union institutions based in the United Kingdom should be determined once the United Kingdom has left the EU. It is too early to speculate on the future location of the European Medicines Agency.”

Early or not, speculation is intense, and others are moving fast to gain advantage. The EMA stated in July that it

“welcomes the interest expressed by some Member States to host the Agency in future”,

while stressing that the decision will be taken

“by common agreement among the representatives of the Member States.”

Various member states are already vying to host the EMA. The Danish Prime Minister has said he is looking at it. The Irish Health Minister has said that attracting the EMA to Dublin is one of the “more interesting” opportunities afforded by Brexit. Italy, Sweden and Spain are also reportedly expressing an interest.

The EMA employs some 900 people. What will happen to their jobs? Will those people move with the agency? Inevitably, there is concern that, should the EMA relocate outside the UK, there will be a knock-on effect on the wider pharmaceuticals and life sciences industries. When they next decide where to locate and invest, does losing the EMA hinder or help? In my view, the answer is fairly clear, but I would welcome the Minister’s view.

We risk losing jobs. We risk losing influence. On a practical level, any company that sells to the European economic area has to have a qualified person for pharmacovigilance—an experienced, senior person based in the European economic area. If we are outside that area, QPPVs would have to move out of the UK or lose their jobs. There are 1,299 QPPVs currently in the UK. That is another potential loss, and of course, every highly-skilled job lost has a multiplier effect.

Perhaps the Minister can give us an estimate of how much all this will cost us. When I asked the Secretary of State for Exiting the European Union that question in the House on Monday, he had no answer. I appreciate that the Minister, following the lead given by the Brexit Ministers, is unlikely to be able to provide detailed, concrete information at this stage. I have some sympathy; if you do not have a plan, it is probably best to say as little as possible. However, I hope that the Government understand just how important it is for the UK to retain the closest relationship possible with the European Medicines Agency. It is important for patients. It is important for businesses. It is important for innovation, and it is important for our economy as a whole.

--- Later in debate ---

[David Mowat]

Clearly when I used the word “finish”, people sprang into action. I will ensure that the hon. Gentleman gets a written answer to his questions on muscular dystrophy.

We do world-class science in this country. We must continue to do so, and to have a world-class pharmaceutical industry, with all that means for value added and input to the Exchequer. Governments are not the reason why we are among the best in the world in gene therapy and cell therapy, and they are not the reason why we have built £60 billion pharmaceutical organisations GlaxoSmithKline and AstraZeneca. It is important that we get the regulatory environment right, and the Department of Health and the Department for Exiting the European Union will ensure that the negotiations we are about to have address those issues.

[Dr Wollaston]

Does the Minister agree that the reason why we have such world-class expertise is the workforce? We must be absolutely clear and send a message to the world that, within our science and research community, we will not be maintaining a list of who is here from the EU and who is a British scientist. We must unequivocally send a message that Britain is open to scientists, researchers and the medical and healthcare workforce from around the world and the EU, not just from Britain.

[David Mowat]

That last intervention—I say “last” somewhat hopefully—unites us all. It would be ridiculous if the world-class science that we must continue to do compromised on matters like that. I completely agree with my hon. Friend’s point, and there is agreement across Government about that. If we need to make that clearer, we should.

I will finish now, as nobody is springing to their feet. I thank all hon. Members, particularly the hon. Member for Cambridge, for putting the issue on the agenda. It is right and important that the topic is at the forefront of our negotiations, and that we get the right answer in the end.