UK pharma reforms delayed until after EU referendum
Major changes to the UK pharma market have been delayed because of the EU referendum on 23 June.
Civil servants must observe a period of 'purdah' in the weeks before a general election or referendum, which restricts government activity to avoid unfairly influencing public opinion.
This has hit two major consultations for the pharma industry – the Accelerated Access Review (AAR) and proposed changes to the medicines pricing system known as the Statutory Scheme.
The AAR is the brainchild of life sciences minister George Freeman, who wants it to re-shape the UK market and the national health service (NHS) around encouraging medical innovation, and remove some of the blocks and bottlenecks which plague the current system.
It released its interim report in October 2015, setting out 5 propositions to speed up access to 'transformative health technology that can change the lives of NHS patients'.
This isn't the first time the report has been delayed – the final AAR report was originally scheduled for autumn 2015, then pushed on to spring 2016 (ie April). Civil servants now say the final report will be launched shortly after referendum day 23 June, and have told pharma that it remains a 'key priority'.
However there remains scepticism about the AAR's ability to have a big impact on the UK sector and NHS uptake of new medicines, medical devices and other new technology – mainly because of the unprecedented squeeze on NHS spending.
Also, the AAR isn't able to recommend changes to the core working of NHS cost effectiveness watchdog NICE, or the main medicines pricing system, the Pharmaceutical price regulation scheme (PPRS). This means the report can't be truly comprehensive, particularly as the pharma industry wants to see fundamental reform to how NICE works.
Despite these delays, industry body the ABPI remains upbeat. A spokesperson for the organisation said: "We still believe that the Review is a great and unique opportunity to enable greater patient access and benefit from new medicines despite the delay in publication."
Top of the ABPI's wish list is for the UK to adopt new medicines more quickly, as it still lags behind European neighbours in this respect. The ABPI says it wants to see "rapid and widespread use of new medicines 'hard-wired' across the entire healthcare system."
Meanwhile the second significant consultation delayed by the referendum is that on the Statutory Pricing Scheme.
This is an alternative pricing system to the PPRS, and has become more popular in recent years for some companies who think it has more flexibility. These include many small to medium sized companies, but also ViiV and Gilead whose HIV and hepatitis C drugs represent a major area of expenditure for the NHS.
Last year the government grew concerned by more companies joining the scheme, and it producing lower savings that the PPRS, a gap which it predicted would widen. Also, the scheme doesn't include price cuts on produces launched after December 2013 – this includes Gilead's high cost hepatitis C drugs Sovaldi and Harvoni.
The Department of Health therefore proposed enforcing either price cuts of between 20% to 30% or a new system of percentage payments of between 10% and 17%.
These proposals have been strongly opposed by industry organisations such as the Ethical Medicines Industry Group (EMIG, many of whose members are on the statutory scheme) and the ABPI.
The ABPI said in September it was concerned the plans sent out "further negative signals globally about the UK's willingness to pay for new and innovative medicines for patients."
Regardless of the delay, some industry insiders anticipate that the government is intent on making statutory scheme conditions so unfavourable that most companies will switch to the PPRS.
