We work across a range of policy areas and with a diverse set of stakeholders. Some of the current issues and policy areas we are working on include:
The Accelerated Access Review
EMIG works closely with the Accelerated Access Review (AAR) and actively supports the Review through its membership of the AAR Reference Group and the numerous associated workshops. EMIG responded to the AAR consultation with its paper 'Access to Medicines - The Beginning of Change', which is available on application via this website.
Pharmaceutical Price Regulation Scheme (PPRS)
EMIG supports a PPRS that:
- Provides transparency on medicine pricing in the UK
- Provides stability for patients, the NHS and industry over a five year period
- Encourages innovation and improves healthcare by bridging the gulf between cost effectiveness and NHS affordability
- Contributes to economic recovery in the UK through increased pharmaceutical investment in R&D and the creation of high value employment
- Recognises the important role of small and medium sized companies (SMEs) in driving the growth of pharmaceutical innovation in the UK
90% of pharmaceutical companies in the UK are small & medium sized companies (SMEs). They provide 40%+ of the branded medicines that are prescribed for patients within the NHS. Importantly, those medicines reflect only 10% of the annual Medicines Bill – these are high quality value for money medicines.
EMIG represents a significant proportion of the UK innovative pharmaceutical industry (see Members List) and 90% of our Members choose to be represented only by EMIG. We believe that the views of the whole pharmaceutical industry are not reflected by the current PPRS negotiating arrangements and the following illustrates why.
The new 2014 PPRS Scheme demonstrates how ‘treating people equally’ is not the same as ‘treating people fairly’.
The prime objective of the PPRS agreement is to achieve zero growth in the Medicines Bill during the first two years of the Scheme and negligible growth in the remaining three.
To achieve this, a rebate scheme is in place (equivalent to an average 8.17% price cut over the five years) and an assurance from the industry that excess growth in the Medicines Bill will be absorbed by increasing the rebate to be paid.
Medicines launched from 2014 are be exempt from the rebate but will contribute to growth in the medicines bill.
However, the primary factors driving the medicines bill are:
- An ageing population living longer and taking more medicines for longer
- Medicines that have been available for c. four years, are more expensive than those treatments they supercede and are now in growth phase – these are the primary drivers of future growth
Unfortunately, pre-existing Patient Access Schemes (PAS) are subject to the rebates.
Additionally, those SMEs with NHS sales below £5m are be exempt from the rebates. In the previous PPRS Scheme, SMEs with annual sales up to £25m were allowed to benefit from the first £5m of their sales being exempt (known as ‘the taper’). The taper was removed from the latest Scheme even though the Department of Health estimated its cost at c. £15m for each year of the Scheme; representing 0.1% of a Medicines Bill that is variously estimated at £12bn annually.
EMIG Member Concerns
- Treating people (companies) equally is not the same as treating them fairly. The medicines that will drive the growth in the Medicines bill for the next five years are easily identifiable. Surely, since they contribute more to growth, they should contribute more in rebates? The majority of medicines, routinely administered by the NHS, have been available for many years. This means two things:
- Their efficacy and safety has been demonstrated
- They have been subject to at least one or two PPRS price cuts, meaning they are much less expensive than the newer arrivals, yet they pay the same percentage rebate
2. The removal of the £5m exemption threshold taper for companies with net sales between £5m and £25m. This means:
- A company with net sales below £5m in 2013 will pay no rebate in 2014
- A company with net sales of £5,000,001 will now pay £187,000 to the Department of Health (DH) in 2014
- There are 39 companies with net sales to the NHS of between £5m and £25m. If DH were to restore the exemption threshold taper to companies up to £25m, it would mitigate a significant blow to SMEs and cost only £14m per year of the PPRS
3. Paying the rebate quarterly. There are two issues here:
- In terms of the Government’s policy of reducing bureaucracy with SMEs, this is counter-intuitive and will represent a significant workload and distraction for small companies. It is also likely to be an increased burden for the Department of Health which will need to check and process these payments
- Companies paying the rebate to the Department of Health within one month of the end of the Quarter may be doing so before being paid by the NHS. This could cause serious cash flow problems
4. When companies agree a Patient Access Scheme (PAS), they agree with Government a level of pricing flexibility that they can afford. It was not anticipated by these companies when they agreed their PAS that these would be subject to the 2014 PPRS rebate scheme.
5. When companies agree a Tender with the NHS, they commit to provide medicines to high-volume customers at a price that is discounted to reflect anticiated Tender volumes. It was not anticipated by these companies that, in addition to these Tender discounts, further rebates would be required under the 2014 PPRS.
Research & Development in the UK
EMIG is committed to stimulating pharmaceutical innovation in the UK by enabling its member companies to work more closely with NHS and academic institutions in order to improve the productivity of their research and development.
R&D productivity in the UK has been declining for some time and EMIG is committed to reversing that trend and to re-establishing the UK as a centre of excellence.
Clinical trial data transparency
EMIG welcomes measures which will increase transparency in clinical research and we believe the release of raw clinical-trial data to other professionals through a suitable gatekeeper could prove to be a valuable resource in driving better-designed and more cost-effective clinical development programmes.
Clinical development could benefit from properly managed open access to clinical trial data sets. It could enable clinical trial programmes to be designed more quickly and targeted more effectively to responsive patient populations and it could reduce the number of unnecessary clinical development programmes, with benefits to patient safety and the R&D portfolio budget management.
Whilst industry should be open to sharing publicly all of the data used to design, execute and report on clinical trials, once a regulatory opinion has been provided on a marketing application, EMIG believes data-sharing needs to be carried out in a controlled way, with well-constructed, prospective requests made by an ‘applicant’ to a future ‘gatekeeper’ authority.
We would not want to see data release simply being made available on public websites. Having a well-meaning, but less than regulatory-standard re-analysis of benefit/risk, could compromise or even seriously risk patient safety. We would thus want to see an application process and gatekeeper to ensure patients are protected.
EMIG works closely with the MHRA on all issues relating to the provision of safe and effective medicines.
UK Data Science Report