# Combination therapies: prioritisation statement

Source: https://www.keypedia.com/records/uk_mhra_guidance/uk-mhra/21e0b478-5648-445c-ae69-e71988721dc6
Type: Notice
Published: November 17, 2023

> The United Kingdom's Competition and Markets Authority (CMA) has released a guidance statement outlining its enforcement stance regarding pharmaceutical companies collaborating to provide combination therapies on the NHS. These treatments, which consist of two or more distinct medicines, often face accessibility issues due to their high cumulative costs. The CMA’s directive aims to clarify that it will not prioritize enforcement action against drug firms that implement a specific negotiation framework designed to improve the availability of these therapies. This policy applies generally to pharmaceutical entities rather than a single company, and as a policy framework, it does not involve specific inspection dates. The main regulatory issue addressed is the potential for competition law violations when companies coordinate on pricing; however, the CMA recognizes that such collaboration is often necessary to meet NHS cost-effectiveness requirements. To benefit from this enforcement leniency, companies must ensure that specific market features are present and that they adhere to strict conditions defined within the negotiation framework. These required actions ensure that the collaborative efforts are focused solely on patient access and do not lead to broader anti-competitive practices. By providing this clarity, the CMA seeks to balance the need for fair market competition with the urgent requirement for life-saving medical treatments to be affordable for the public health system. Firms are expected to maintain transparency and limit their cooperation to the parameters set out by the authority to avoid future regulatory scrutiny.

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## Content

In this statement, the Competition and Markets Authority (CMA) clarifies the circumstances under which it will not prioritise enforcement action against drug firms when they implement a specific ‘negotiation framework’ to make more combination therapies available on the NHS. The CMA’s statement applies only where certain market features are present and particular conditions are met. Combination therapies are treatments using 2 or more medicines in combination.

## Attachments

- [Prioritisation statement on combination therapies](https://assets.publishing.service.gov.uk/media/6554fd97d03a8d001207f9f9/Prioritisation_statement_on_combination_therapies.pdf)