June 21, 2018

The European Medicines Agency to Find a New Home After Brexit

By Xcenda

In June 2016, the United Kingdom voted in a referendum to leave the European Union. "Brexit," as it's known, includes the move of two UK-based EU agencies, the European Medicines Agency (EMA) and the European Banking Authority (EBA) to a location within the remaining EU member states. This article looks to answer some key questions regarding the departure of the EMA from its London-based headquarters and the effect that this move could have on UK-based pharmaceutical manufacturers and the UK’s current status as an important player on the global drug development stage.

HTA QUARTERLY | SUMMER 2018

The European Medicines Agency to Find a New Home After Brexit

By Martine Etschmaier, MPH, and Chelsey Campbell, PharmD, MBA, MS

On June 23, 2016, the United Kingdom (UK) voted in a referendum to leave the European Union (EU). With this decision to exit the EU, the UK government initiated a 2-year transition period, colloquially known as “Brexit,” with the departure from the EU to become official on March 29, 2019. As part of the departure comes the painstaking task of moving 2 UK-based EU agencies, the European Medicines Agency (EMA) and the European Banking Authority (EBA), to remaining member states. Naturally, this move raises many questions: Where should the new agency headquarters be located? With the departure of these 2 agencies, what will be the future role of the UK on the world stage in banking and medicine?

In this article, we will look to answer some key questions regarding the departure of the EMA from its London-based headquarters and the effect that this move could have on UK-based pharmaceutical manufacturers and the UK’s current status as an important player on the global drug development stage.

Where is EMA moving? Is the decision final?

On November 20, 2017, the EU Member States determined that the EMA headquarters will be relocated in Amsterdam, the Netherlands. This decision follows a joint assessment by the European Commission and EMA of the formal offers submitted by 19 member states seeking to host the EMA. The assessment was based on multiple criteria, including the proposed location, accessibility, education facilities, labor market, social security and medical care, business continuity, and geographical spread of each of the applicant locations. The decision was finalized in February 2018, with scheduled completion of the relocation to a temporary headquarters on the outskirts of Amsterdam by March 2019 (to coincide with the Brexit finalization date). A permanent, custom-built headquarters in Zuidas (Amsterdam’s financial district) is currently scheduled for completion by the end of year 2020. The Dutch government will foot the bill for the temporary offices until the building is ready for the permanent headquarters.

How would this relocation affect EMA staffing?

A major consideration before relocation was its potential effect on EMA staffing. The more than 900 EMA employees were informed that the pending move to Amsterdam will occur (and be made permanent) even if the UK decided not to move forward with Brexit at a later date. This has significant implications for British nationals employed by the EMA, who are unlikely to remain on staff after the move, especially if and when Brexit occurs.

According to a survey conducted in November 2017, over 80% of EMA staff are expected to move to the new headquarters in Amsterdam. However, this still leaves a significant gap in terms of staffing in relation to EMA’s current workflow demands and responsibilities. It remains to be seen if approval delays or other roadblocks occur as a result of temporary staffing shortages. In a recent move, in response to concerns from British citizens working for the European Commission in Brussels about their post-Brexit status, the European Commission President Jean-Claude Juncker urged Belgium to grant them citizenship. It remains to be seen if this proposal is accepted and sets a precedent for a similar request to be made to the Dutch government for British EMA staff who may want to relocate to Amsterdam.

What resources are available to help manufacturers understand the next steps involved in this move?

To help ensure a smooth transition without interruption in pharmaceutical supplies, the EMA has created a dedicated website to provide pharmaceutical companies with information to assist them with changes related to Brexit and the move of the headquarters to Amsterdam. Information regarding the joint governance structure agreed upon by the EMA and the government of Netherlands is available along with details on the 5 work streams related to the move: 1) temporary premises; 2) permanent premises; 3) staff relocation; 4) financial and legal aspects; and 5) external communication. A tracking tool is also available to follow the timeline and progress of the work streams. A bevvy of other resources related to the move can be found on the EMA’s website.

What will happen to products with marketing authorization holders located in the UK?

Given the lack of precedent regarding a member state leaving the EU, there are many unanswered questions about what will happen to products that are manufactured and monitored in a country that is no longer a member state of the EU. Given the scenario that Brexit will be finalized by March 30, 2019, any marketing authorization decisions made after that time would not include the UK as a co-rapporteur. Drugs already authorized by the EMA at that time will remain authorized in the UK.

As recently as March 2018, Prime Minister Theresa May vocalized the UK’s desire to remain a part of the EMA, similar to how Iceland and Norway currently function as co-rapporteurs with the EU-27. The feasibility of this arrangement has yet to be determined and, thus, the EMA’s current working assumption is that the UK will be a separate “third country” without access to the EMA’s resources.

To help assess Brexit’s impact on the pharmaceutical supply and marketing authorization, the EMA distributed a survey in early 2018 to marketing authorization holders across the EU. The aim of the survey, according to the EMA, was to:

Identify companies where there is a need for concerted action to address medicines supply concerns due to Brexit in order to protect human and animal health, and
Help the agency and the European Commission plan resources in the areas where these submissions will be processed

The survey specifically targeted marketing authorization holders of centrally authorized products (CAPs) that:

Are located in the UK, or
Have quality control sites, batch release sites, or import manufacturing sites in the UK, or
Have a qualified person for pharmacovigilance (QPPV) or pharmacovigilance system master file in the UK

The survey asked marketing authorization holders to detail their plans to submit transfers, notifications, or variations to their marketing authorizations in the context of Brexit. Another key goal of this survey was to encourage marketing authorization holder planning for the EMA move.

According to the preliminary data that are available from the survey, 427 of 1,165 (36.6%) CAPs have UK-based marketing authorization holders. Furthermore, 323 of 1,165 (27.7%) CAPs have UK-based QPPVs. These early findings highlight the importance of strategic planning for marketing authorization holders assuming Brexit is finalized in 2019 and, thus, keeping a finger on the pulse of marketing authorization holder Brexit plans will be key for EMA for at least the next 12 to 18 months. The complete findings of this survey will be presented to the EMA’s management board this year, and a high-level summary will be made available publicly online.

What’s next for the EMA and the UK?

Despite all of the progress thus far, many details remain unclear for the UK’s post-Brexit involvement in the EMA. It remains to be seen whether or not the UK will maintain a relationship with the EMA, which could have a massive impact on manufacturers located in the UK. The quickly changing situation dictates that manufacturers with EU operations based in the UK keep a close eye on developments with regard to the evolving situation and prepare contingency plans for either scenario, which should become clearer as the Brexit date approaches. All manufacturers, regardless of location, may also need to be prepared to navigate a new marketing authorization process for the UK. However, with proper planning and dedication to staying up to date on developments, manufacturers can be ready for a new UK approval situation post-Brexit.

This article should be references as follows:

Etschmaier M, Campbell C. The European Medicines Agency to find a new home after Brexit. HTA Quarterly. Summer 2018. June 21, 2018.

Sources:

https://nltimes.nl/2018/03/02/ema-confirms-move-amsterdam https://nltimes.nl/2018/03/16/european-parliament-approves-ema-move-amsterdam http://www.ema.europa.eu/ema/index.jsp?curl=pages/news_and_events/news/2018/01/news_detail_002890.jsp&mid=WC0b01ac058004d5c1 http://www.ema.europa.eu/ema/index.jsp?curl=pages/news_and_events/news/2018/02/news_detail_002914.jsp&mid=WC0b01ac058004d5c1 http://www.ema.europa.eu/ema/index.jsp?curl=pages/news_and_events/news/2018/03/news_detail_002923.jsp&mid=WC0b01ac058004d5c1 http://www.ema.europa.eu/ema/index.jsp?curl=pages/news_and_events/general/general_content_001707.jsp&mid=WC0b01ac0580a809a7 https://ec.europa.eu/info/publications/european-medicines-agency-individual-assessment-summaries_en http://www.europarl.europa.eu/ireland/en/news-press/ep-plenary-session-newsletter-12-15-march-2018 https://www.theparliamentmagazine.eu/articles/news/eu-parliament-approves-new-brexit-resolution-ema-amsterdam-relocation http://www.bbc.com/news/uk-politics-32810887 http://www.bbc.com/news/world-europe-43987980 https://www.dutchnews.nl/news/2018/01/dutch-pick-up-tab-for-ema-move-as-amsterdam-stretches-in-size/ http://www.biopharminternational.com/prime-minister-wants-uk-remain-part-ema-after-brexit-0

Topics:

Market access Commercialization