The future of patients in the UK lies in the hand of the Brexit negotiators, with uncertainty as to whether regulation in the field will stay under EU responsibility or the UK will have to adopt its own regulatory framework.
In preparing the divorce of the UK from the EU, a smooth transition in the life sciences is necessary to avoid delays in getting medicines to the people.
“We need to be ready for Day One,” Virginia Acha from the Association of the British Pharmaceutical Industry (ABPI) told MPs in a Committee hearing in early December. “Success for us really means when on Day One patients here in the UK don’t miss a beat with regard to their medicines.”
In order to ensure this process, the questions that the Brexit negotiators need to address are complex and will have a strong effect on healthcare in the UK.
The most symbolic representative of this uncertainty is the European Medicines Agency (EMA). The EMA, currently located in London, is the central organ responsible for the approval of new medicines by issuing market authorisations. For companies operating in the EU, the existence of this institution offers large financial and administrative benefits.
Getting medicines authorised by the EMA allows companies to market their products in every EU member state instead of following the submission procedure in every single European country separately. According to ABPI, the Agency serves a market of 500 million people living in the EU, comprising 25% of global pharmaceutical markets. In 2015, EMA approved 93 new medicines for the European market, as stated in its Annual Report.
Since 1995, the EMA has been located in London, with a current staff of close to 900 employees. With Brexit looming ahead, this may change soon, putting the fates of these employees in the hand of the Brexit negotiators.
Whether the EMA stays in London or moves to another EU member country depends, according to Rebecca Harding from the EMA, “on the future relationship between the UK and the EU. This is unknown at present and therefore we will not engage in any speculation.”
While the Agency does not wish to speculate, it has set up an internal Task Force focused on financial preparedness and analysing the impact that relocation will have. A report from an October meeting of the EMA Managing board announces that “facts and figures on the Agency’s operations and logistic features are being prepared to respond to the numerous requests by cities and governments expressing an interest in hosting the Agency in the future.”
While the EMA refrains from making predictions on the outcome of the deal between the UK and the EU, several member states have already expressed an interest to act as its hosts. Which states specifically, the Agency does not know. “Expressions of interest to host the Agency are not made directly to EMA,” Harding explains. A recent Bloomberg report on this topic mentioned Sweden, France, Denmark, Hungary and Bulgaria as some of the interested parties.
Regulating the future
The uncertainty about the EMA represents just a small part of the questions about the future of pharmaceutical regulation in the UK. Depending on the outcome of the negotiations between the EU and the UK, different scenarios may become a reality.
A recent analysis by PwC applies some popular post Brexit scenarios to the pharmaceutical industry. If, after leaving the EU, Britain remains an EEA member – a model similar to that of Norway - Britain would retain access to the EU market. Medicines that are authorised in the EU would have to be nationally authorised in the UK.
A bilateral agreement that resembles the Swiss model would see the UK approving medicines and granting clinical trials separately from the EU. Mutual recognition of the quality of the British and European medicines would ensure quicker market access.
A Free Trade Agreement (FTA) would allow for the UK to negotiate the terms they desire. Here it would be in UK interest to negotiate as unlimited an access to the market as possible.
In the case of a “hard exit”, a complete separation of UK pharmaceutical regulation systems from those of the EU would take place. This would mean that the UK would have to create its own regulatory body and set up its own set of regulations.
However, even a hard Brexit would probably not see the UK adopting a completely new book of rules. A report commissioned by the European Federation of Pharmaceutical Industries and Associations (EFPIA) found last year that “there would not be any advantage for the UK in developing a market authorisation process that was divergent from the EMA.” This is due to the risk of causing delay in marketing authorisations and additional costs for companies.
One possibility is that the national body for the regulation of medicines, MHRA, will take over the responsibilities of the EMA after Brexit. Both agencies are already co-operating closely, as can be concluded from several reports on the EMA website that mention MHRA involvement in the evaluation of drugs. Currently, the "MHRA is working closely with the Government to analyse the best options and opportunities available,” Sarah-Rose Burke, spokesperson for the MHRA, said. She did not wish to further comment on the specific preparations taken within MHRA or whether MHRA may soon be the main regulatory body for pharmaceuticals in the UK.
ABPI supports the MHRA as the new main regulatory body in the UK but stresses the importance of a close regulatory co-operation between the MHRA and the EMA, because this “would be the best way to ensure effectiveness and safety, reduce any potential disruption to UK medicines supply, and would make sure NHS patients are best placed to access new medical advances at the same rate as the majority of Europe."
A common regulatory framework with Europe is also the favoured scenario of the UK EU Life Sciences Transition Programme, a group brought to life by George Freeman MP and consisting of representatives of ABPI and BIA, the UK Bioindustry Association, as well as industry professionals.
The Programme states that “the resource, time and expertise required to build and legislate for a stand-alone regulatory model would be significant – and not in the interests of UK patients or industry.” Leaving the European regulatory system could mean that the UK becomes a ‘second priority’ launch market, with new medicines submitted with a delay or not at all. This could result in delayed access to new products for UK patients relative to European patients.
The Big Move?
The questions of how medicines will be regulated after Brexit and where the EMA might move are not the only challenges coming toward Brexit negotiators.
They are joined by the possibility that pharmaceutical companies will re-evaluate the attractiveness of the UK as a location for their business.
A report by Ernst & Young points towards the fact that many international companies have their European regulatory headquarters in the UK because of the close proximity to the EMA. “In the event of a hard exit, the EMA will have to move, as will the regulatory European centres of many of these companies,” the report argues.
Andrew Ross, Media Relations Manager at ABPI, agrees but points out that this is a scenario with a lot of “ifs and buts”. Whether or not the regulatory centres of global pharmaceutical companies move away is subject to the deal with the UK – if the EMA is to leave London but the UK remains part of a shared single market, this scenario will not come to pass.
If, however, the UK will have to establish its own regulatory system, regulatory centres of companies “could move to make a jump to remain part of that European market,” Ross concedes.
None of the contacted companies – among others Pfizer, GSK and Gilead – wanted to offer commentary on the issue. However, GSK’s CEO Sir Andrew Witty stated in a September BBC News interview that GSK “are working under the assumption that we will not [be part of the single market],” with GSK’s preparations assuming “a WTO environment with FTAs rather than a continuation of the single market.” This implies that a move of the European regulatory affairs departments of GSK may be considered.
While regulatory centres might move if the EMA does, Virginia Acha from ABPI told MPs in early December that the move of the Agency would not make the UK a generally less attractive place to invest. Neither would it make entire companies move away. “You have to have good relationships with the regulator, that’s without a doubt. But some companies can manage that next door or they can manage that from more of a distance,” she said. “It’s not going to be the only reason why anybody leaves.”
Whatever the result of the Brexit negotiations, the fact remains that patients in the UK will be directly affected. If the UK chooses to follow the model of the EMA and access the European market through a centralised procedure, it will have to accept regulatory dependence on the EU.
Other scenarios see the UK having to negotiate free trade agreements, which may well result in delayed market access of new medicines in the country. Furthermore, the United Kingdom may lose importance in international competition. Companies may prioritise other markets before submitting medicines for approval in the UK. This will directly affect the quality of healthcare in this country.
As Virginia Acha from ABPI put it when talking to MPs: “If you have to do it separately, you can do it separately, but it does make it a lot easier to stick within the arrangements agreed.”