By Anthony Walker, PhD, Managing Partner

There’s a lot of sound and fury about Orkambi in the UK. Following a rejection from NICE, Vertex and NHS England have not been able to reach terms and the product is not available in the UK's National Health Service (NHS), effectively barring it from over 90% of the potential UK market. Usually, the motto “a No from NICE – just cut the price” is the route to market access, but apparently not in this case.

The arguments are straightforward: Vertex doesn’t want to be bullied into giving what it feels is an excessive discount, the NHS has a finite drugs budget and funding Orkambi at the price Vertex would accept would deny reimbursement of other products that are currently used to treat patients with other important medical needs. The current position is a stalemate.

Bill Wiggin, the Conservative MP (member of parliament) for North Herefordshire, has stated “Vertex refused the largest ever financial offer the NHS has made in its entire history for this medicine”. Apparently, this involves a commitment by the NHS to pay Vertex £500m over a five year period for access to the drug for all eligible patients treated by the NHS but this seems to be a discount that Vertex is unwilling to offer. Mr Wiggin as now asking the government to invoke “Crown Use” for Orkambi. Crown Use refers to legal provisions within the UK patent law that allow for the government to make use of patents without the authorization of the patent-holder. Specifically, these provisions are found within Sections 55-59 of the UK Patents Act 1977 (as amended), and are supported by international agreements such as the Agreement on Trade-Related Aspects of Intellectual Property Rights (TRIPS).

This seems to be an empty threat: sound and thunder signifying nothing. The reality is that even if Crown Use were invoked, the government would have to find a manufacturer who would not only produce the drug but would have to conduct all of the Rx development work to submit the product for a marketing authorization. The product has been approved by the EMA which grants registrants an eight year data exclusivity period from approval during which time a generic manufacturer cannot cross refer to the originators data. So in practice a generic manufacturer would need to conduct a full pharmaceutical development program, submit a dossier for approval and wait for authorization to be granted before a generic version could reach patients. Not only would this entail a multi-year delay, but it is seriously questionable that anyone would invest the resources to do this for the sake of sales in the UK market alone.

Who knows where this will end? Could a hard Brexit[1] change the equation if the UK is no longer subject to EMA rules? This piles uncertainty upon uncertainty and I wouldn’t bet on it. The one thing I would bet on is that the threat of Crown Use is an empty one and that access to the drug for the UK patients who are in urgent need of Orkambi, will only happen through sensible negotiations between the NHS and Vertex. Let us hope.

[1] Hard Brexit is a possible outcome if the UK leaves the EU with no agreement in place. All EU laws and treaties will no longer apply in this scenario

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