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IN all the talk about Brexit, there has been relatively little discussion about the impact of Britain's leaving the EU on the availability of veterinary medicines. In view of this, an article published on the online platform Pharmafile.com last month is of interest.1 Although it concerns the impact of Brexit on the human pharmaceutical sector, similar considerations are likely to apply in the veterinary field.
While highlighting the uncertainties around Brexit, the article, by Vincenzo Salvatore, a former head of legal services at the European Medicines Agency (EMA), suggests that a number of possible downsides can already be identified in terms of implications for the European pharmaceutical sector and how companies do business in the UK. One consequence will almost certainly be that the EMA, which is currently based in London, will have to move elsewhere, given that EU institutions and bodies have to be based in an EU member state. From the UK's perspective, the article suggests, UK regulators will lose their membership of various European regulatory networks and, more generally, will not have ‘a seat at the table’ where major decisions are made, such as on the adoption of new rules or revision of existing rules governing the EU pharmaceutical sector.
The extent to which EU rules will continue to apply in the UK after it leaves the EU will depend on the approach taken by the UK government, but, the article suggests, it is ‘extremely unlikely’ that the UK will no longer want to be able to rely on the European internal market and the free movement of medicinal products. In that case, it suggests, there are two available options. Under the first of these – the ‘Norway model’ – the UK would join the European Economic Area (EEA), whose member countries (currently Norway, Iceland and Liechtenstein) agree to implement EU legislation, acknowledge EU administrative decisions and comply with European case law. This approach, the article explains, would enable a relatively swift and smooth transition to a legal framework for the pharmaceutical sector that would be little different from the current framework and would allow, for example, the UK to benefit from a new harmonised procedure for the approval of clinical trials.
The second option – the ‘Swiss model’ – would involve the UK rejoining the European Free Trade Association (EFTA). Under this scenario, EU medicines rules would not automatically apply and, while the UK might continue to benefit from free movement of goods, an implication for pharmaceutical businesses would be that they would have to obtain a separate marketing authorisation from the UK regulatory authorities to sell medicinal products in the UK. In this case, the article suggests – somewhat ominously – that UK pharmaceutical companies with no offices or manufacturing plants in the EU/EAA might consider relocating to an EU/EAA country to continue to benefit from the advantages associated with being established in the EU/EEA.
The UK Government clearly has a lot to sort out in the wake of the Brexit vote and, in this context, there is a danger that facilitating the development and authorisation of medicines might be seen as just one issue among many. However, given the international nature of the pharmaceutical business, and its importance to the economy and employment in the UK, the implications of any decisions will need to be thought through carefully. This applies as much in the veterinary as in the human pharmaceutical sector, albeit that the veterinary sector is smaller (and therefore, perhaps, potentially more vulnerable).
Too many of the intricacies of Brexit are becoming apparent after the referendum when they should have been discussed beforehand, as highlighted in a report this week from the pressure group the Electoral Reform Society (ERS).2 The ERS drew attention to ‘glaring democratic inconsistencies’ in the run up to the vote, describing the debate in the UK as ‘dire’. It must be hoped that, now that a decision to leave the EU has been taken, the quality of debate improves. After the broad and often misleading claims during the referendum campaigns, attention must now be devoted to the detail, with proper regard to the facts.