Brexit Effect: 5 Questions for the European Medicines Agency

Siobhan Harris

Disclosures

October 29, 2018

Brexit could have a major impact on the UK's pharmaceutical industry. However as there is, as yet, no certainty about the Brexit deal as a whole, there's also a lack of clarity about specific implications for the movement of medicines to and from the UK.

The pharmaceutical sector in the UK has a turnover of more than £40 billion a year. A recent UK government report on the impact of Brexit suggested that leaving the EU without a deal would risk damage to the UK industry, possibly making it a less attractive place to launch new medicines. It would also risk affecting patients.

The report confirmed that 73% of pharmaceutical imports to the UK come from the EU. That's 37 million packs of medicines every month. Also, 45 million packs of medicines leave the UK every month to go to Europe.

There have been warnings about possible shortages of medicines and the need to stockpile in the case of a no-deal Brexit.

Whatever the eventual deal, one significant consequence of Brexit to the pharmaceutical industry in the UK is the relocation of the European Medicines Agency (EMA) from the UK to the Netherlands.

The EMA evaluates pharmaceutical products across the EU and has been based in London since 1995. It's moving to Amsterdam next year.

The British Government wants to keep close ties between the UK's Medicines & Healthcare products Regulatory Agency (MHRA) and EMA after Brexit. Prime Minister Theresa May in a speech earlier this year even spoke of the UK paying to be an associate member.

So far that hasn't happened.

   

Melanie Carr

Medscape UK asked Melanie Carr, head of the EMA's Stakeholders and Communications Division about the current situation.

Q&A

Medscape UK: How is the move to the Netherlands from London progressing?  How many staff are relocating? 

Melanie Carr: Plans for the physical move of EMA to Amsterdam are well on track. We are working closely together with our Dutch counterparts to ensure that the preparations advance smoothly and agreed timelines are met. Initially, in March 2019, EMA will move to temporary premises pending completion of the construction of our final premises, which will be fully operational and functional as of mid-November 2019.

However, staff retention is a concern as it has become clear that the Agency will lose a substantial number of staff. According to latest estimates from the end of September, in a best-case situation we could lose 24% of our overall workforce of over 900 staff. This includes 125 short-term contracts which will no longer be able to provide their services to EMA after its relocation, due to the difference in the employment rules in the Netherlands compared to the UK. Information still changes on a daily basis as more staff make decisions as the date for relocation approaches and therefore we are monitoring the situation closely.

Medscape UK: How do you see the UK's relationship with the EMA after Brexit?

Melanie Carr: The terms of any future relationship, as well as the situation with regard to medicines regulation post-Brexit, is subject of the negotiations between the UK and the European Union, in which EMA has no formal role. Therefore, I am not in a position to comment on this topic.

Medscape UK: How do you envisage future working relationships with the UK's MHRA post-Brexit?

Melanie Carr: As far as rules and regulations are concerned, as mentioned previously, we cannot speculate on medicines regulation post-Brexit as this is part of the negotiations between the UK and the European Union, in which EMA has no formal role.

However, on a more personal level, EMA is a scientific organisation and science has no borders. We have built personal relationships and have excellent working relations with our colleagues from the Medicines & Healthcare products Regulatory Agency (MHRA), so of course we are sad to see them leave the network.

Medscape UK: What are your main areas of potential concern after Brexit?

Melanie Carr: One area where we are very active is to ensure the continuous supply of medicines for both human and veterinary use. The European Commission, EMA, national competent authorities together with the marketing authorisation holders have a collective responsibility to make sure that patients continue to have access to their medicines.

Together with the European Commission, we have been providing guidance to help pharmaceutical companies prepare for the withdrawal of the UK from the EU since May 2017. Companies need to take the necessary regulatory steps to keep their medicines on the market post-Brexit. We are monitoring the situation closely and are in constant dialogue with the companies for whom critical regulatory steps are currently taking place in the UK, to ensure they submit the necessary variations to the marketing authorisation of their products to allow continued supply in the EU.

We are also looking forward to being able to restart activities that had to be postponed, suspended or reduced due to the loss of staff and the need to focus on our operational preparations for Brexit.  We are very optimistic that we will be able to fill vacancies quite quickly as recent recruitment efforts showed that many qualified people are interested to work for the Agency.

During the past months we have received and screened over 3500 applications for the various positions we have advertised. We are putting in place a knowledge transfer and training programme to ensure that the expertise and knowledge of those leaving us is retained in-house and that their activities can be covered by other colleagues.

Therefore, we do realise that the next couple of years could be challenging, but longer term, we will be back stronger, fully engaged and ready to implement the next regulatory network strategy beyond 2020. And certainly, the move to Amsterdam will be a good opportunity for EMA to refocus and make sure that we are well prepared for the regulatory challenges ahead.

Medscape UK: What stage is your business preparedness plan at?

Melanie Carr: The UK’s withdrawal from the EU has a major impact on the operations of EMA. We have developed and implemented a dedicated Brexit business continuity plan (BCP) to address the physical move of the Agency as well as the potential staff loss and the necessary changes to operations and procedures after the withdrawal of the UK from the EU. The plan enables EMA to address two situations which may arise linked to Brexit; firstly, the need to free up resources to prepare for Brexit, including EMA’s relocation to Amsterdam and secondly, the need to address staff loss which in the short term cannot be compensated through recruitment.

We have just launched, on 1st October, the third phase of our Brexit preparedness business continuity plan (BCP). In this context, we are temporarily suspending or scaling back additional activities. This is to ensure that resources can be redeployed to allow us safeguarding our core activities related to the evaluation and supervision of medicines, and that this work can continue without interruption and to the same quality.

Activities which are to be suspended or scaled back fall into six key areas: international relations, guideline development, meetings, programmes and projects, stakeholder communication and clinical data publication, and are detailed in our implementation plan. For example, we will focus our development of guidelines on those which address either an urgent public or animal health need, or are necessary to support and facilitate preparations for Brexit, or the implementation of new or revised legislation.

We anticipate that phase 3 will have to be complemented with additional temporary suspensions and reductions as of 1st January 2019, which will be launched as part of phase 4 of the BCP, in order to facilitate our physical move to the Netherlands.

The temporary reduction of activities is currently expected to last until 30th June 2019, but will be reviewed in April 2019, once the Agency has completed its move to its temporary building in Amsterdam.

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