"The way we regulate the marketing and authorisation of new drugs would also be thrown into confusion. The European Medicines Agency is the hub of EU pharmaceuticals regulation; it is based in London. Were the UK to leave the post-Brexit government would face a huge administrative undertaking to establish a separate regulatory system for pharmaceutical safety. Taken all together these changes would make the UK a far less attractive place for life science investment."Except that the EMA serves the countries of the European Economic Area as well as having Mutual Recognition Agreements with Switzerland. The chances of ending cooperation with the EMA are remote. Not forgetting course the influence of the International Standards Organisation and the World Health Organisation.
The WHO is charged with the tasks of developing and maintaining global norms, international standards and guidelines for the quality, safety and efficacy of drugs, and providing guidance in harmonization efforts.
The development of norms, standards and guidelines to promote quality assurance, medicines regulation and safety of medicines is an integral part of WHO’s Constitution and a unique responsibility. It has been endorsed and supported through numerous World Health Assembly resolutions, and more recently in those on the Revised Drug Strategy.
The increasing globalization of commerce and trade, and the merging of pharmaceutical companies, are internationalizing pharmaceutical production. International pharmaceutical norms and standards are thus more important than ever before since they serve as global tools aiming to ensure safety and quality of medicines. One of WHO’s roles is to continue to develop such international norms and standards, and to help countries implementing them.
Safety and quality of pharmaceuticals are also being promoted through regional and international efforts to harmonize drug regulation, such as those led by, ASEAN (Association of South-East Asian Nations), CAN (Andean Community), CADREAC (The Collaboration Agreement of Drug Regulatory Authorities in European Union Associated Countries), the European Union, Gulf Cooperation Council (GCC), the International Conference on Harmonisation (ICH), MERCOSUR (Southern Common Market) the Pan American Network on Drug Regulatory Harmonization (PANDRH) and the Southern African Development Community (SADC). These efforts are to be welcomed since international consensus on quality, safety and efficacy standards can speed up access to medicines.
The EU is just as bound by that which is passed down to it as anyone else. Like most other areas of regulation, pharmaceuticals regulation is heavily contingent on global standards and practices and in many instances will not be the originator of its own rules.
There is zero reason to believe the UK is going to go down the road of unilateralism and deviate from the global standard or even the EU standard without just cause. On that basis there is no good reason why we would not be able to obtain a mutual recognition agreement in the unlikely event that we did not secure an EEA based agreement.
The short of it is, not much is going to change unless of course we want it to. Rather than being "a huge administrative undertaking to establish a separate regulatory system", the chances are much would be left as is - not least because insurance companies will insist on conformity to international standards. The NHS is not immune from such commercial influences. The only likely deviation is in those instances where our own exceptional health system decides that deviation is in the interests of service improvement or innovation, in which case we have a direct line to the top tables rather than going via the EU. I'm not seeing a downside.
Burstow also has it that leaving the EU would undermine the UK’s defences against infectious disease, citing our involvement in the European Centre for Disease Prevention and Control in Stockholm. "Given recent threats from Ebola and the Zika virus, this hardly seems a good time to weaken our defences" he says. Well quite. But with all transboundary concerns like communicable diseases it's in nobody's interests to be exclusionary, nor is there any sane reason why the UK would be isolationist. Iceland, Liechtenstein and Norway also participate in the ECDC. There is no reason why we would not. Again we should also note that no system operates in isolation and most governments have means of coordinating their responses to threats.
As usual we're not looking at credible reasoning to stay in the EU. We're looking at paranoid histrionics from people who would like us to believe that international cooperation does not happen without the EU and that Brexit necessarily means the end of international cooperation and pooling of resources. And that is really something that characterises europhilia. A fundamental dishonesty in seeking to convince voters that civilised society did not exist before the EU and could not possibly continue without further EU political integration.
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