Alex Ledger discusses what the loss of the EMA means

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Joy division?

 

Will the loss of the European Medicines Agency (EMA) result in slower drug access for UK patients? It will according to Sir Alasdair Breckenridge – former chair of the The Medicines and Healthcare products Regulatory Agency (MHRA) – and it might do more than that.

Several countries are vying to give a home to Europe’s medicines licensing agency. Barcelona, Milan, Lyon, Dublin, Amsterdam, Stockholm and Budapest have all apparently submitted their interest. All offer sensible prospects, however, the stakes are high. An EMA staff survey, recently reported in the FT, has been presented to the agency’s governing board, which showed that about 50% of employees would leave in the event of relocation to an undesirable city.

Even losing a fraction of this number would dramatically restrict the EMA’s work programme, slowing down the rate of evaluations and, ultimately, approvals. All European patients would suffer.

The EMA relocated to large headquarters in London’s Canary Wharf two years ago. In those modern facilities, 890 medics, scientists and bureaucrats determine the licensing and monitoring decisions for medicines throughout the European Union. Additionally, the agency coordinates 36,000 national regulators and scientists each year, from across the continent, who approve the safety and efficacy of drugs.

To accompany this, a specialist regulatory industry has blossomed in and around London, supporting companies through the EMA’s processes. Relocation of the agency means the potential loss of highly-skilled professionals who will, inevitably, take their skills, taxes and expense budgets elsewhere.

Naturally, concern has also been raised in Parliament. During Prime Minister’s Questions SNP MP Philippa Whitford – member of the health select committee – raised a probing question, inquiring as to the Government’s plans to tackle the departure of the EMA. Theresa May’s retort was devoid of detail other than to say it was ‘looking into the matter’.

Jeremy Corbyn’s shadow health secretary, Jonathan Ashworth MP, has publicly stated that he has written to Jeremy Hunt, characterising the Government’s handling as “reckless”, carrying with it a “damaging loss of jobs and wealth”.

Securing a good deal for medicines regulation is fast becoming a high-profile feature of the proposed Brexit negotiations. Any agreement will need to reassure industry that the UK will not represent a substantial hurdle to secure access. Achieving this is a tough demand.

An option to avoid disruption and cost would be an agreement for the UK to continue participating in the EMA and its regulatory system. There is precedent for this. Norway, Iceland and some smaller European countries are members and subject to its rulings. To achieve this, however, those countries had agreed to be members of the single market and, as part of this, accepted core EU principles such as free movement of people, goods, capital and services. There is no appetite within the Government to entertain such a ‘soft’ Brexit.

Another suggestion would be to automatically adopt post-Brexit EMA rulings by uniting the MHRA and NICE to make them a more appealing prospect to industry. A single, integrated agency responsible for an end-to-end value assessment of new technologies could speed up regulatory decisions and reimbursement. This would be a positive development.

Nevertheless, both bodies have prominent independent reputations – both domestically and internationally – and will be keen to protect their respective territories. NICE operates an international consulting arm, and the MHRA uses its expertise to conduct reviews on behalf of the EMA – it currently approves about 25% of all medicines in the EU.

To duplicate the EMA’s work would entail a substantial uplift in resource and cost. It is hard to see how Government would finance this without passing some cost onto industry. MHRA already charges and NICE has proposed new fees for its own assessments. These latter reforms have sensibly been paused for the time being, in light of Brexit, and will await publication of the Government’s industrial strategy in the coming months.

Somewhere the risks of European departure for the future of the life sciences sector are being listened to, but worryingly there remains little convincing detail about proposed solutions.   

 

EMA in numbers

Licenses medicines in 28 EU states

Equates to 25% of the world’s total drug market

Serves a combined population of 500 million people

The UK on its own is about 3% of the global market.

 

New order

Should Breckenridge’s views cause concern – would the impact of Brexit create a two-tier regulatory system in the UK? EMA as the major market, and the MHRA – or a succeeding body – as the second. If so, pharma could be deterred from launching in the UK early, particularly if it came with additional costs.

Theresa May’s government has suggested that much of EU regulation is readily adoptable and can be quickly ‘copy and pasted’ into UK law. Industry figures have been quick to endorse this, suggesting that a system of mutual recognition with the EMA might offer a workable solution. Some legislative experts, however, have been more sceptical.
There are suggestions that, because a sizeable proportion of EU regulation is considered to refer directly to European institutions or other EU legislation, it cannot be easily transferred.

The EMA – an agency subject to the European court system – has been clearly marked out as not featuring in the Government’s post-Brexit plans. Indeed, it was the judgements of this court which fuelled much of ‘Team Leave’s’ messages in the run up to the referendum. One of their core arguments was the cutting of the overly constrictive regulatory order to ensure the UK was not subject to decisions from the European Court of Justice after Brexit. It would be an Olympic effort to row back on that one.

 

Alex Ledger is Deputy Managing Director at Decideum – the views expressed are entirely his own. Go to decideum.com