Competition Markets Authority
The Competition and Markets Authority (CMA) has today issued a statement clarifying that certain types of engagements between competing drug firms working on combination therapies will not be prioritised for investigation making it easier for drug firms to work together to develop vital treatments for use in the NHS. The CMAs statement comes in response to concerns that the CMA could intervene to stop these types of collaborations under competition law.
Combination therapies combine two or more individual drugs into one treatment and have become increasingly important to treat a range of serious conditions, most commonly cancers. They can provide better health outcomes than individual drugs because, in combination, these drugs can target the disease more effectively.
These combination therapies can only be approved for use on the NHS if they are shown to be cost effective. The Association of the British Pharmaceutical Industry (ABPI) told the CMA that, since 2017, half of the combination therapies for cancer treatments involving branded drugs, submitted for assessment to the National Institute for Health and Care Excellence (NICE), have withdrawn from the process entirely or were assessed not to be cost effective.
In some cases, a combination will only be cost effective and commercially feasible if there is some form of co-operation between drug firms, and businesses have raised concerns that such co-operation might be investigated by the CMA. Therefore, the CMA is playing its part by clarifying where and how competing drug firms can work together to give them more chance of meeting the cost effectiveness threshold and getting these vital drugs to market.
The CMA has worked closely with the ABPI, NHS England (NHSE), and NICE to deliver this public statement, and engaged with relevant bodies in all 4 nations of the UK to help ensure patients can benefit, wherever they are based. By complying with the conditions outlined in the CMAs statement, drug firms will be able to negotiate a commercial agreement with the comfort that the CMA will not prioritise this conduct for investigation. However, the information exchanged between drug firms must be limited to what is strictly necessary to reach the commercial agreement, and drug firms cannot share the confidential price of their individual drugs.
Ann Pope, CMA Senior Director of Antitrust, said:
Tens of thousands of NHS patients are missing out on innovative combination therapies. Concerns from competing drug firms that theyll fall foul of competition law for working together is not the only reason why more of these therapies arent available to NHS patients, but the CMA is playing its part by explaining how firms can negotiate and avoid being investigated.
Our statement is designed to provide clarity and comfort to firms who follow the rules, ultimately aiming at more people being able to access vital treatments. It is not a free pass, and any companies engaging in anti-competitive behaviour will continue to be robustly investigated by the CMA.
Fiona Bride, Director for Medicines Value & Access at NHS England, said:
NHS patients are already benefiting from access to combination cancer therapies, but its clear that industry concerns about competition law may act as a barrier to a wider range of combination treatments reaching patients that could benefit.
This vital step by the CMA now provides a clear position that commercial deals involving multiple medicines licensed by different companies can be agreed, under specific circumstances, so that NHS patients can benefit from the latest combination therapies for a range of conditions at a fair price to taxpayers.
Helen Knight, Director of Medicines Evaluation at NICE, said:
NICE is seeing an increasing number of combination therapies coming through its health technology assessment pipeline, so it has been important for us to support the CMA in delivering this statement.
We believe that allowing companies to engage with each other in these very specific circumstances will increase the opportunity for these therapies to progress through NICE evaluation. This has the potential to get better treatments to patients, faster.
As well as the benefits to patients that come from having more combination therapies available on the NHS, there are wider benefits for growth and innovation in the pharmaceutical sector. More companies should have the confidence to invest in and bring combination therapies to market, ultimately achieving greater value for money for the NHS. These objectives align with the CMAs Annual Plan for 2023 to 2024, which puts people, businesses and the UK economy at the heart of its work.
Notes to editors
- You can read the full statement here. As circumstances evolve, the CMA may, as appropriate, revisit and / or update its statement.
- Combination treatments are being developed for a range of serious diseases like advanced renal cell carcinoma, lymphatic leukaemia, multiple myeloma, lung, breast and metastatic gastric cancers. The clinical potential for combination therapies has also been recognised in non-cancer diseases, including treatment of HIV, hepatitis C, rheumatoid arthritis, and COVID-19.
- The CMAs statement not to prioritise investigations under the Competition Act 1998 applies to specific forms of engagement between drug manufacturers carried out according to the negotiation framework which are carried out in good faith and aimed at making a combination therapy available to NHS patients. It applies only where certain market features are present and particular conditions are met, as described in the statement. Outside of these specific circumstances, this statement does not provide any advice or guidance about the CMAs enforcement of competition law in the pharmaceutical sector.
- Todays statement is consistent with the CMAs strategy, as set out in its Annual Plan for 2023 to 2024, notably focusing action on core areas of consumer spending - specifically, in this case, caring for ourselves and others. Its also an example of how the CMA is enabling open access to markets for innovating businesses, so that the whole UK economy can grow productively and sustainably.
- All media enquiries should be directed to the CMA press office by email onpress@cma.gov.uk, or by phone