President Trump is apparently to be told by Boris Johnson that the NHS is “off the table” in any negotiations with the UK Government over trade, but there are other ways in which a trade deal can be exploited by the USA, which will inevitably result in a higher drugs bill for the NHS.
In February 2019, the USA published its specific negotiating objectives for a post-Brexit trade deal with the UK. They include the following: “Seek provisions governing intellectual property rights that reflect a standard of protection similar to that found in U.S. law”. Intellectual property rights were then the subject of the US-UK trade discussions on 25th July 2019 (which are the subject of redacted documents produced after a freedom of information request to the DTI). In the context of medicines, the USA will therefore no doubt be asking the UK to implement a link (in law) between pharmaceutical patents and the drug regulatory approval process (“patent linkage”), such as the Americans have.
The US experience shows that patent linkage can seriously delay the time at which cheaper generic drugs enter the market, whilst any patent disputes are resolved. It is not supported in the European Union and we currently have no such system in the UK. Bear in mind that a generic drug may be priced at a small fraction of the price of the same drug before generic entry and one gets an approximate flavour of the millions currently saved by the NHS through its use of generic pharmaceuticals.
In any negotiation over trade, it seems naive to assume that America will readily drop this issue, bearing in mind its current protectionist outlook and the importance of its domestic pharmaceutical industry. The British Government is hardly likely to be in a position to hold out against US insistence on a ‘patent linkage’ provision, in the face of a much more powerful and economically stronger counterparty, for whom equivalent intellectual property protection with its trading partners is a ‘red line’.
A lot of time and effort has been expended on the “what if” debates concerning Brexit, but a significantly higher drugs bill for the NHS seems inevitable, if we are to pursue a US trade deal following an exit from the European Union.
* Duncan Curley is a member of the Liberal Democrats and a director of an IP law firm.