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What would BREXIT mean for pharma?

Published on 16/02/16 at 10:12am

It began with a promise to UK voters to end ‘benefit tourism’ and to negotiate more flexibility in the UK’s relations with the EU. Recently it was called a ‘mistake' and openly criticised.

If in the upcoming referendum promised in the Government’s election manifesto, the people of the UK vote to leave the EU, and for “legally binding and irreversible” changes, what are the implications for the vibrant UK & EU pharma industry? 

Pharma must continue to raise concerns over the potential impact of this change on itself, on patients and other stakeholders, at a time when productivity, synergies and access to treatments are key success factors. Patient groups are also engaged and are requesting information from industry over the effect of the UK cutting ties with the EU.

Overview

In negotiating an improved deal for the UK, Prime Minister David Cameron sought a more competitive EU and more trade deals. He also wanted national parliaments to play a key role, recognition that Britain won’t be part of the ‘ever closer union’ sought by other members; and guarantees that euro-zone members will not discriminate against non-members. Public debate has focused on the request for an ‘emergency brake’ on migrant workers, and to suspend tax credits and housing benefits for up to seven years. The question of supremacy of EU courts over national courts in Britain is also a hot topic amongst lawyers.

Cameron returned from the EU negotiating table in late February, having won more concessions than may have been expected, but not enough to silence the Eurosceptics in multiple UK political parties. The Prime Minister, however, said he'd achieved enough to advocate the UK remaining in the Union, and confirmed a referendum date of June 23, 2016.

Data from ONS, ABPI and EFPIA

In February, the UK Office for National Statistics said sales of British goods to the EU fell 8% to a six-year low of £134 billion in 2015. This is £31 billion less than in 2011. By contrast, exports by British companies to non-EU countries grew more than 2% to £151 billion in 2015: representing 53% of overseas sales. Exports to the US soared 27.1% to £47.5 billion.

Production of pharmaceuticals has contributed almost 10% of the UK’s GDP, doubling since 1995. In 2014, UK pharma generated a trade surplus, about £3 billion. The PPRS scheme of 2014 provides multi-million funding for UK healthcare through unique initiatives.

In Europe, the industry employs 700,000 people. In 2012 its trade surplus was €80 billion and pharma’s expenditure on R&D in 2012 was more than €54 billion; just over 10% of this was contributed by UK-based research. In growth markets such as Italy, investment in R&D grew by over 10% between 2014 & 2015. By value in 2014 USD sales, combining retail and wholesale, the largest markets after USA, China & Japan are: Germany, France, Italy and the UK.

Potential implications of a BREXIT include costs that it would be premature to speculatively estimate. This is a brief summary of some possible implications, for which, if there is an ‘out’ referendum vote, the pharmaceutical industry must be prepared.

Business Investments and Inward Trade: Potential relocation of headquarters and production sites, higher labour costs, significant regulatory burdens for a new system for authorisations, potential import duties for British goods entering the new EU single market could off-set the benefits of new trade deals negotiated by an independent British negotiating team (for example, how would Britain join in TTIP talks?). 

Isolation of Regulators & Academic Centres: The European Medicines Agency could leave London, as it must be based in a member State. There would be a weaker role in the EU for the MHRA, and NICE would no longer automatically be included within the EUNetHTA initiative and would lose access to important information about pricing and innovative pricing models in the EU. UK regulators would also lose the opportunity to be included in multilateral negotiations with FDA.

Access to EU-wide databases on clinical trials, pharmacovigilance data and health and safety data could be subject to ‘access fees’. There are many open questions.

Academic centres in the UK would lose the benefits of current close links with other academic units within and outside of the EU and funding that is financed by the EU.

IP Rights, Guidance & Regulation: Current proposals will not affect the Unitary Patent Convention (UPC) and current systems for filing, registering and challenging patents at a national level. There would be calls for the London-based UPC Court for pharmaceutical patents to relocate to Paris or Munich. 

To avoid legal uncertainty on ‘exclusivities’ such as data exclusivity contained in existing EU legislation, Britain would probably continue to apply existing EU laws. If it were to challenge future EU regulation, for example on data privacy, this would increase costs for businesses seeking harmonised regulation across member states.  

Even if rulings of EU Courts were no longer binding on UK courts, they might still be ‘persuasive’. It might be more difficult to enforce UK judgments in Europe, which this would be a major issue for UK entrepreneurs.

Before the exit, the industry would be consulted on transitional arrangements. There would still be high cost for business, specifically for a new system to approve medicines, report adverse events and manage interactions with multiple stakeholders for example on transparency of data and trials.

R&D funding, incentives & public-private initiatives: Such funding is sensitive to changes in financial flows. Comparisons with R&D funding into Switzerland over a decade  shows Switzerland received less than half of R&D payments into the UK, despite pro-industry incentives and an IP-friendly environment.

UK-based SMEs would be subject to a withdrawal and only a partial refund of FP7 and Horizon 2020 funds.

Impact on EU Budget: How would the EU find the net €11bn that Britain contributed in 2013? EU Treaties already impose a two year notice period on Member States requesting an exit. Even if this period can be extended, it is not clear how the EU would make up the shortfall and projects such as the Innovative Medicines Initiative and HTA research projects could be cut.

Update: 22/02/16: This article was updated to reflect the fact that the date of the UK EU referendum has been confirmed as June 23, 2016.

This article was contributed by Helen Roberts and V. Salvatore, of the Healthcare Team at law firm BonelliErede

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