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Case study 02

The European Medicines Agency

Picture of medicine pills

The European Medicines Agency a decentralised agency of the EU – is based in London. It is responsible for the scientific evaluation, supervision and safety monitoring of medicines developed by pharmaceutical companies for use in the EU

The European Medicines Agency, which began operating in 1995, protects public and animal health in 28 EU member states, as well as the countries of the European Economic Area. It ensures that all medicines available on the EU market are safe, effective and of high quality.

The outcome of the EU referendum introduced a question mark over its future location. A Commons debate at Westminster Hall in October sought to discuss and clarify this.

During the debate, the UK location of the agency was praised as a significant achievement of the then prime minister, John Major.

Moreover, it was linked to the importance to the UK economy of the pharmaceutical industry.
The life sciences sector in the UK has a turnover of £60bn a year; generates exports worth £30bn a year; invested £4bn in research and development in 2014; and employs 220,000 people.

Furthermore, 25% of the world’s top prescription medicines were discovered and developed in the UK.

One Prospect member at the EMA has expressed concern about the meaning of the vote for the agency’s future and also for the personal circumstances of pharmacovigilance specialists.

“In the pharmaceutical industry, jobs tend to be very specialised and each area is separate from the rest, so I can only comment on my area of expertise: pharmacovigilance.

“In the EMA, pharmacovigilance staff make up about a fifth of the human medicines scientific staff, just to give you an idea of the sort of scale.

“I assume that in a drugs company, with manufacturing arms and such like, that proportion is far lower.

“In a company’s pharmacovigilance department the most experienced, senior and best-paid person is the Qualified Person for Pharmacovigilance. The QPPV must reside in the EEA and so must their deputy.”

There are currently 7,199 QPPVs in the EEA, he says, of whom 1,299 are in the UK.

QPPVs for small drugs companies with only UK products would be unaffected, but any company that sells to the European Economic Area would have to have a QPPV within that area, meaning that their QPPVs would have to move or lose their role.

In time, pharmacovigilance departments in the UK would be relocated to where that QPPV is, leaving the UK parts as little more than rump offices, filing notifications. This would essentially limit career progression for pharmacovigilance, and the UK would suffer a significant brain drain.

The delay in getting new cancer drugs, for example, would vary from company to company.

Smaller biotech companies of the type pioneering revolutionary new cancer treatments do not have the capacity to file multiple applications at once and handle all the assorted paperwork – each application involves thousands of pages – so they would have to pick one market first and then move on to the next one.

The member points out that US and Japanese companies already file in their home markets first before coming to the EEA.

He suggests they would go to the EEA before the UK, because in the EEA all innovative products – for example treatments for cancer, diabetes, AIDS and arthritis – are centralised through the EMA, so one application covers all countries in the area.

The EMA has 210 days from the receipt of an application to grant or refuse authorisation and the European Commission must take the final decision – based on the EMA’s advice – within a further month.

“However, that period includes clock stops where we ask the agency’s Marketing Authorisation Holders (MAH) for more information. In practice it is more likely to take ten months than eight.”

He adds: “The knowledge of things like biologicals in particular is very specialised. So we really do need a whole continent’s worth of experts to do the assessments, especially to counter the claims of experts paid by the pharmaceutical industry.

“The UK will lose access to that pool of expertise across the continent and so the assessments will probably take a bit longer or just be a copy and paste EMA decision – so much for taking back control, and it may well be far more than six months later.”

In addition, many biologicals are now coming off patent and generics (called biosimilars) will be available. These are also centralised, but will be much cheaper than the current biologicals.

“If the MAHs have to pay to get into the UK market, too, they might be disinclined to bother and if they do, they will certainly wait until after EEA approval. This means the NHS will have to wait many months before it can access these cheaper drugs and thus treat more people/save money as applicable.

“Whether the EMA can stay in London appears doubtful. Currently we are told no, but I guess we will be a pawn in the negotiations.

“If we don’t, it may influence industry to seek alternative places to operate and so the UK should make a serious attempt to allow us to stay. However, many other countries have already seen the advantage of housing the agency and so I am not sure there is much hope.”

  • www.ema.europa.eu/ema