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As the risks grow of a disorderly UK withdrawal from the European Union, the warnings about what could go wrong for the supply of medicines in Europe become ever louder.
As the risks grow of a disorderly UK withdrawal from the European Union (and I write this as Theresa May emerges empty-handed from today's Brussels summit of EU leaders, to return to her precarious position as a prime minister unable to get the UK parliament to approve the withdrawal she has laboriously agreed with the EU, and unable to extract any meaningful concessions from the EU that would ease its passage), the warnings about what could go wrong for the supply of medicines in Europe become ever louder.
And now the warnings are coming from the UK government itself, which until now has been operating largely on the Micawber principle that things will probably all work out well in the end.
The UK's most senior health minister, Matt Hancock, has just written to all the pharmaceutical companies that supply medicines to the UK from, or via, the EU, admitting that a 'no-deal' Brexit cannot be ruled out-in other words, at the end of March the UK may be out of the EU, with no agreement in place on trade or anything else, and with no transition period to adapt.
The drug industry itself has been well aware of this risk, and since long before the UK government awoke from its delusion-or deceit-that Brexit would be easy. Every month, 82 million packs of medicines move between the UK and the EU, most of them on the short sea crossing between Calais on the northern French coast and Dover on the south-east tip of England.
As EFPIA, the main European drug industry association, has repeatedly pointed out, if the UK leaves the EU without a deal in March 2019, industry will be powerless in the face of controls at the borders between the UK and EU. Customs and other checks at ports and borders will cause delays to shipments of medicines and time critical clinical trial materials, and the absence of a deal would even hit air transport, as planes would no longer be certified to fly between the EU and the UK. It is not just a UK problem: many patients in Europe are dependent on medicines manufactured in the UK, and they too will be hit. Bureaucracy, and the massive traffic congestion that would be generated., would affect both exports and imports. Companies are planning to use different routes to and from the UK where capacity exists, but this is limited. There are also difficulties with geographic location, and with suitable secure and refrigerated storage facilities for medicines.
Now Hancock recognizes that "the UK government does not have control over the checks which member states impose at the EU border"-and under standard EU rules, there will be controls on people and goods entering the EU from the UK just the same as if they came from Morocco or Mexico.
Early government advice to companies to stock up in advance, just in case, is now being upgraded by Hancock. "Manufacturers may need to make additional arrangements", he says in his letter. Revised government planning assumptions are that there will be significantly reduced access for up to six months.
As the head of the UK BioIndustry Association warned in early December, "a ‘no deal’ Brexit would mean the biggest disintegration of the complex regulated medicines market across Europe in terms of regulation, cross border movement of goods, comparative pricing, and intellectual property." The drug industry in Europe-and European patients' organizations and scientists-have been pleading with both sides to negotiate an agreement that at least protects medicines supply, even if there is a no-deal Brexit. But this is looking unrealistic.
Theresa May has just survived-but only just-a challenge to her leadership from her own party members, has just accepted that at present there is no prospect of persuading parliament to back the deal she has negotiated, and has just been politely told to solve it herself by the governments of the other 27 members of the EU.
She has no workable deal. No other deal is in sight. And the UK will cease to be a member of the EU on March 29 2019-in just over three months from now. That is an unhealthy situation, in every sense of the word.
Peter O'Donnell is a freelance journalist who specializes in European health affairs and is based in Brussels, Belgium