On 17 November 2023, the UK Competition and Markets Authority published a statement clarifying that specific types of collaborative conduct involving competing medicine suppliers which work on bringing a combination therapy to market by supplying that therapy at a “cost effective price” to the National Health Service (NHS) will not be prioritised for competition scrutiny (see, attached press release). From a practical perspective, this means that if such firms observe the principles set forth in the CMA’s “Prioritisation statement on combination therapies” (PSCT, also attached), including the terms of a negotiation framework that was prepared by the Association of the British Pharmaceutical Industry, they will find themselves in a safe haven and will not be investigated for a possible infringement of the competition rules.

 

The combination therapies for which the CMA seeks to create a pathway to market are treatments consisting of two or more medicines used in combination. An increasing number of such treatments is found to generate better health outcomes in a range of areas, including oncology, HIV and hepatitis C.    

 

While the CMA’s approach must be understood against the specific backdrop of the regulatory framework prevailing in the UK, the two principal competition concerns which the CMA tries to address will apply to many jurisdictions. These are (i) the exchange of competitively sensitive information between actual or potential competitors; and (ii) pricing arrangements between actual or potential competitors (PSCT, point 3.1, at p. 11). The PSCT offers guidance that is designed to alleviate these concerns.

 

To minimise the risks to competition associated with exchanging information between competitors, the PSCT puts forward the principle that the information exchanged should be limited to what is strictly necessary to reach a commercial agreement between the two marketing authorisation holders and implement a mechanism that allows one party to make a contribution payment, which refers to an amount per patient, to the other party in order for that second party to submit a successful application for the reimbursement of the combination therapy. The PSCT goes on to list the categories of information whose exchange it will countenance (PSCT, point 4.4, at p. 13 and p. 14).
 
As regards pricing arrangements, the PSCT allows for the suppliers of the component medicines of the combination therapy to negotiate and agree the contribution payment which is designed to compensate the applicant for the reimbursement of the combination therapy for its willingness to offer its component medicine to the NHS at a price low enough to cause the combination therapy to satisfy the “cost effectiveness” test and thus qualify for reimbursement by the NHS (PSCT, point 4.2, at p. 12).

 

The CMA hopes that its approach will increase the availability of important combination therapies. At the same time, it recognises the possibility of alternative approaches to make combination therapies available to NHS patients (PSCT, point 5.8, at p. 18). Similarly, the CMA is prepared to revisit the PSCT or update it as circumstances evolve (PSCT, point 5.9, at p. 18).
 
The PSCT is the first known public stance of a competition authority in Europe regarding combination therapies. Further guidance emanating from a different regulatory environment would be welcome. Sweden might be next in line. The Swedish competition authority is believed to take a look at a Swedish combination therapies access model for oncological products which was submitted to TLV, the Swedish payor, in June 2023.