European Medicines Agency

Daniel Zeichner Excerpts

Wednesday 12th October 2016 Westminster Hall

[Daniel Zeichner (Cambridge) (Lab)]

I beg to move,

That this House has considered the future of the European Medicines Agency.

It is a pleasure to serve under your chairmanship, Mr McCabe. I am grateful for the opportunity to secure the debate, which I called with the expectation of being answered by a Minister from the Department for Exiting the European Union. It is unclear to me why that is not happening; perhaps that could be No. 171 on our list of questions about Brexit. None the less, I am sure we can expect a robust and helpful response from the Under-Secretary of State for Health, the hon. Member for Warrington South (David Mowat), who perhaps can explain that to us.

I start by laying my cards on the table. I am old enough to remember the John Major Government and the Maastricht treaty; I was perhaps one of the few at that time who actually read it. I also remember the troubles that the then Prime Minister had. Despite those difficult times, one of his major achievements was to secure the location of the European Medicines Agency in the United Kingdom. More than 20 years on, that success by a Conservative Prime Minister is being put at risk by the foolish path being pursued by the Conservative Government today. John Major famously referred to some of his colleagues—I apologise for this, Mr McCabe— as “bastards”; now they are running the show.

Last week, the Chancellor wryly commented that no one voted for Brexit to make us poorer. I wonder how many knew about the potential impact on one of our key industries, the future of which we are discussing today. My guess is that very few knew and that very few were voting to destroy British jobs and to do reckless damage to one of our great success stories. The area of the country I represent is a world leader in pharmaceuticals and life sciences. The Cambridge biomedical campus is at the pinnacle of international research, with, just a few years ago, AstraZeneca choosing Cambridge as its location rather than elsewhere in the world—but that was before 23 June.

Given that the vast majority know nothing of all this, let us set out some of the details about the European Medicines Agency and the significant role it has played over the past two decades in providing a harmonised approach to medicines regulation throughout the European Union. It was set up in 1995 from predecessor organisations, is a decentralised agency of the European Union and is located in London. Its mission is

“to foster scientific excellence in the evaluation and supervision of medicines, for the benefit of public and animal health in the European Union”.

Responsible for the scientific evaluation of human and veterinary medicines developed by pharmaceutical companies for use in the European Union, it can grant marketing authorisations for medicines that allow for their use across the 28 EU member states, as well as the countries of the European economic area—Iceland, Liechtenstein and Norway.

The EMA describes its four main functions as to facilitate development and access to medicines, to evaluate applications for marketing authorisation, to monitor the safety of medicines across their life cycle and to provide information to healthcare professionals and patients. Essentially, it is tasked with ensuring all medicines available on the EU market are safe, effective and of high quality, and it seeks to harmonise the work of existing national medicine regulatory bodies, such as the UK’s Medicines and Healthcare Products Regulatory Agency. It serves a market of more than 500 million people living in the European Union and covers a market of 25% of global pharmaceutical sales, of which the UK constitutes just 3%.

We should understand the EMA in the context of the growing global pharmaceutical market and the UK’s world-leading life sciences sector. The Prime Minister herself said in July:

“It is hard to think of an industry of greater strategic importance to Britain than its pharmaceutical industry”.

Indeed, the life sciences sector in our country has a turnover of more than £60 billion per year and generates exports worth £30 billion. In 2014 it invested £4 billion in research and development—more than any other sector. It employs 220,000 people in our country and 25% of the world’s top prescription medicines were discovered and developed in the United Kingdom. In my constituency of Cambridge alone, there are more than 160 life science companies reinforcing the strong local knowledge economy, and contributing to the economy well outside my region as well.

In passing, it is perhaps worth noting that Cambridge is one of just a handful of UK cities making a net contribution to the UK Treasury, thanks in no small part to its vibrant life sciences industry. Thus, the Cambridge view on how we secure future prosperity may perhaps be worth listening to. Cambridge, and those in this key sector, are most certainly unhappy with the current route being taken for a range of reasons and the future of the EMA is a good example. What will be its future, post-Brexit? What will be the impact on the future of our country’s life sciences industry more generally? What will be the real impact on the NHS—the real impact, not the bus slogan? The head of NHS England, Simon Stevens, has rightly insisted that the regulation of medicines and devices must be considered during the Brexit negotiations.

What are the options? As I have noted, countries inside the European economic area are included within the EMA’s centralised marketing authorisation procedure, which means that, if the UK remains part of the economic area, the process for regulating and supplying medicines in our country might see little change, which could bring stability for the sector.

[Nick Thomas-Symonds (Torfaen) (Lab)]

It is a pleasure to serve under your chairmanship, Mr McCabe. My concern is that, outside the European Union, we will be in a position in which pharmaceutical companies will have to go to the EMA to go through the process to make the drugs available, and subsequently have to do the same thing for the purposes of UK law, which will cause delay. Does my hon. Friend agree that it is important that we have parallel processes so that there is no disadvantage to patients in this country?

--- Later in debate ---

[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 ---

[Daniel Zeichner]

I thank all hon. Members who have taken part today. As so often in these Westminster Hall debates, we have had a much more constructive, collaborative discussion than we might have had in the other Chamber.

The hon. Member for Strangford (Jim Shannon) said that the die is cast. This morning I was described on my local radio station, BBC Radio Cambridgeshire, as a “remoaner” by one of the more constructive UK Independence party MEPs. I was not sure whether to be insulted or flattered, but my retort was that I think I am a realist. Today’s debate has shown a realistic understanding of the challenges and options that lie ahead. I am encouraged, perhaps more than is helpful for the Minister with regard to his ministerial friends in the Brexit Department, by the suggestion that the European economic area option is the best one for this sector. Many of us will be making that case, and I suspect that the debate will continue. It is right to highlight the importance of the sector, and I am thankful for the opportunity to do so today.

Question put and agreed to.

Resolved,

That this House has considered the future of the European Medicines Agency.