Posted 20 January 2017
By Nick Paul Taylor
Welcome to our European Regulatory Roundup, our weekly overview of the top EU regulatory news.
The Netherlands Formalizes Interest in Hosting EMA Post-Brexit
The Netherlands has gone public with its desire to host the European Medicines Agency (EMA) if the regulator leaves London following Brexit. The list of European countries lobbying to host EMA’s headquarters post-Brexit is long, but the Netherlands has set itself apart by formalizing its interest in a press release.
Government officials presented details of the Netherlands’ desire to give EMA a new home after the UK leaves the EU in a statement. The statement sets out why the Netherlands thinks Europe would be best served by moving EMA to near Amsterdam Airport Schiphol, a busy international transport hub on the outskirts of the Dutch capital.
“Relocating EMA to the Netherlands would guarantee its continuity for Europe as a whole, in an environment and with secondary conditions that more than measures up to its current situation in the UK. We are conveniently situated, with excellent transport links and we also have expertise in hosting international organisations,” Bert Koenders, Dutch foreign minister, said.
In pitching to host EMA, Dutch officials are talking up the quality of the housing, healthcare, public transport and education in the country. These factors could persuade many of EMA’s 900 staff to relocate with the agency, easing the transition and cutting the risk of disruption to regulatory services. The level of English spoken in the Netherlands would further ease the relocation process for staff who are used to life in the UK.
The Dutch Medicines Evaluation Board (MEB) welcomed the government’s pitch to host EMA, noting it is already a key supplier of expertise to the EU-wide regulator. Given EMA’s current reliance on the UK Medicines and Healthcare Products Regulatory Agency (MHRA) for support, the ability of the new host nation to collaborate with the EU institute could be a factor in the European Council’s decision on its home post-Brexit.
While the Netherlands’ press release formalizing its interest in hosting EMA is unusual, its desire to provide a new home for the regulator is shared by multiple European countries. Sweden, Ireland, Spain, Denmark, Germany and Italy are all reportedly in the running. Each has points in their favor, from the types of logistical strengths talked up by the Netherlands to more political considerations, such as the EU’s desire to distribute its institutions across the region.
The prospect of EMA remaining in London after the UK leaves the EU, an idea talked up by British politicians but widely dismissed in the EU, became even less likely this week after more details of the probable post-Brexit relationship emerged. Theresa May, the UK Prime Minister, said she planned to take the country out of the single market, confirming months of less direct suggestions that it is heading toward a relatively clean break from the EU.
May is expected to trigger article 50 by the end of March, at which point the UK and EU will have at most two years to negotiate the terms of the separation. The Dutch want a decision on the new home of EMA to be made in parallel to these negotiations.
“It goes without saying that EMA needs clarity about its future as soon as possible. Its work is too important to everyone in Europe to postpone the matter until after the Brexit negotiations,” Koenders said.
Press Release,MEB Statement (Dutch)
EMA Creates Ground Rules for Increasing Involvement of National Regulators
EMA has created ground rules for expanding the role of national regulators in post-authorization procedures. Publication of the rules follows requests from national competent authorities (NCAs) to extend the multinational assessment team (MNAT) concept beyond pre-authorization.
MNATs were introduced in 2012 to increase NCA involvement in EMA scientific committees. Under the MNAT concept, assessment teams can be made up of NCAs. EMA sees the approach as a way to make use of the resources possessed by NCAs while minimizing administrative costs. Rather than use its own staff, EMA pays each NCA directly. The amount each NCA receives is dictated by the remuneration share letter.
Having contributed to tens of initial application and scientific advice teams, NCAs told EMA the process works well and they want to see it expanded to cover post-authorization procedures. EMA, while broadly supportive of the idea, thinks preparations must be made before use of the model is expanded. This thinking is based on a belief that application of the MNAT concept to post-authorization procedures poses some specific challenges that must worked through prior to the expansion. Specific issues include the length, complexity and breadth of the post-authorization phase.
To address these challenges, EMA has published a list of ground rules and a proposed workflow for applying the MNAT concept post-authorization. The ground rules are intended to ensure the process is flexible, enables the transfer of knowledge about a drug from pre- to post-authorization phases and has an efficient and transparent payment system. These rules underpin a three-step workflow proposed by EMA.
Officials are planning a phased introduction of the workflow. The first step, which will start this year, is to allow existing MNAT pre-authorization rapporteurships and co-rapporteurships to have the same role in post-authorization applications to extend the line or indication of a product. If this goes well — and NCAs want to continue to expand their role — EMA will broaden the model to cover other procedures and scenarios.
Norwegian Regulator Reorganizes to Accelerate Access to Medicines
The Norwegian Medicines Agency (NoMA) has reorganized to enact a strategy intended to achieve goals including accelerating access to medicines. NoMA’s new structure splits it into four subunits focused on ensuring fast access to new drugs, securing the supply chain and other tasks.
Prior to the reorganization, NoMA was split into more units. By consolidating its operation around strategic objectives, such as securing the supply chain, NoMA hopes to encourage collaboration. Ultimately, NoMA thinks this will improve its ability to meet the objectives set out in its strategy for 2016 to 2020.
The four subunits cover access to new drugs, supply chain security, proper use of medicines and the shared administrative functions these three departments need to function. NoMA has put a different person in charge of each of the teams. These leaders report to Audun Hågå, the director of NoMA.
Hågå is planning a phased introduction of the new way of working to avoid the disruption that could result from an abrupt change. NoMA thinks this will enable employees to influence the transition process.
NoMA Statement (Norwegian)
Metformin, Paracetamol Recalled in Italy After Inspection of Indian Plant
The Italian Medicines Agency (AIFA) has endorsed the withdrawal of certain metformin and paracetamol products from the country. Manufacturers are withdrawing the products after the inspection of a facility in India revealed noncompliance with good manufacturing practices (GMPs).
There is no evidence the GMP failings have affected the safety or efficacy of the products, but they are nonetheless being withdrawn as a precautionary measure. AIFA has endorsed the voluntary recall. Products sold by Mylan are among those affected.
The recall follows a GMP inspection by Portuguese regulator Infarmed. Earlier this month, Infarmed listed metformin from Mylan among the products affected by the findings of an inspection of a facility run by Granules India.
AIFA Notice (Italian), Infarmed Report (Portuguese)