ABPI Scotland: Medicines in Scotland

1. ABPI Scotland:Medicines in Scotland

2. What is ABPI? • Membership body of the Pharmaceutical Industry – statutory negotiating body • Represents majority of research based companies • Members supply over 90% of medicines to the NHS • 2/3rd of all research and development of new medicines is undertaken by member companies • ABPI Code of Practice - administered by PMCPA http://www.pmcpa.org.uk/Pages/default.aspx

3. Investment • The pharmaceutical industry globally invests more in research and development than any other industry – £12.1 million every day. • The pharmaceutical industry employs around 25,000 people in R&D in the UK (Business Enterprise Research and Development (2008, 2009, 2010) 2010 released Nov 2011 – Office for National Statistics (ONS).

5. ABPI: Key issues... • Uptake and innovation • Pricing: is it a barrier to uptake? • Clinical research: are we under threat? • Who we are and how we operate

6. ABPI: Key issues... • Uptake and innovation • Low and slow

7. Market share of innovative products in the UK is behind European peers and deteriorating Market share for products -brands and generics- launched in the past 5 years by value (%)(1) Branded medicines launched in the past 5 years are expected to account for 5% of spend only by 2015, similar to previous years’ levels NICE’s ~40% rejection rate and NICE ‘blight’ lead to delays and limited access as well as poor performance in innovation uptake(2) • IMS Health World Review Analyst, 2010 • OHE analysis 2012

8. Uptake of new medicines in Scotland (OHE stats)

9. Uptake of new medicines in Scotland... Scottish Government recognised there is a problem: • CEL 17 (and follow-up CMO) • Statement of Intent • New medicines review (recently announced) Scottish Parliament has recognised there is a problem: • Public Petitions Committee inquiry • Health & Sport Committee Inquiry (ongoing)

10. ABPI: Key issues... • Pricing: is it a barrier to uptake?

11. Overall, UK spending on medicines as a percentage of GDP (developed countries)… Spending on medicines as a percentage of GDP in various countries in 2011(1) If Spain cut down pharmaceutical spend by 20%, the proportion of GDP would be 1.2%, i.e. still higher than in the UK’s • (1) IMS Health World Review Analyst 2012. OECD Health Database.  All data accessed March 2012

12. The UK has severe uptake issues in critical therapy areas Spend per capita on cancer medicines launched in the previous 5 years in Europe (£)(1) £ The UK has the lowest per capita spend in cancer medicines launched in the past 5 years • IMS Midas 2006

13. Branded pharmaceutical prices are amongst the lowest in developed countries Position of the UK in the ranking of branded pharmaceutical prices by year(1) (1) OHE, 11th Report (2004-2010); 5th Report (2000 - 2003); 2011: OHE calculations based on IMS and PCA data. Note: blank cell = Not available Notes: Table includes the years prior to PPRS negotiations (2003/2004; 2007/2008) as well as for 2010 and 2011 Exchange rate used: Average of Q4 of every year. In a recent report (September 2012) The European Commission has indicated that the UK is a highly efficient medicines market

14. Betweeen 2011 and 2015 (at list prices - OHE)... • Total medicines bill for NHSScotland is projected to increase by 2.9% - 3.9% (£1.37bn - £1.43bn) • Branded medicines bill for NHSScotland is projected to increase by 0.5% - 1.5% (£0.99bn – £1.03bn)

15. ABPI: Key issues... • Clinical research: are we under threat?

16. While the pharma sector contributes 1 in 2 R&D pounds in the UK(1), it is in decline National origin of leading 100 global medicines by sales 2004–2011 (2) UK Global Share of patients in clinical trials 2000 – 2010(3) -77% % of global sales of leading 100 medicines by country of origin 6% 2% 1.4% 2000 2006 2010 Twelve major pharmaceutical site closures between 1996 and 2012(4) • ONS UK Business Enterprise Research and Development, 2009 • Department of Health, MISG, Pharmaceutical Industry: Competitiveness and Performance Indicators 2009 • Centre for Medicines Research (www.cmr.org); Global Clinical Performance Metrics Database; Kinapse report • ABPI analysis

17. Don’t just take our word for it... • Evidence given to the Health & Sport Committee inquiry into new medicines from: • a group of 17 oncologists • Oral evidence of a further oncologist • Cancer Research UK: “The UK’s lower rate of uptake for new cancer drugs may be damaging to our ability to design and run internationally competitive studies. If very few patients can get licensed drugs that are the standard of care outside the UK, this could lead to fewer industry-supported trials being conducted in the UK”

18. A changing relationship

19. The industry position on trial registry and the publication of results ABPI Code of Practice 2012 • all trials must be registered within 21 days of the initiation of patient enrolment • results positive or negative, must be published within one year of marketing authorisation

20. Where will we be in 2016? On transparency of financial relationships • Payments to health professionals across Europe will be publicly declared • Medical Education Grants to Healthcare Organisations will be publicly disclosed • All payments to patient organisations will be publically disclosed On access to clinical trial and safety information • All trials are registered • All results published within one year of marketing authorisation • Results from past trials accessible via the EMA criteria • Proactive publication of unprecedented levels of safety data for all marketed medicines in the EU

21. The future…

23. The future… • Harder and more expensive to develop medicines – no more blockbusters… • Personalised medicines… • Less money, more patients… • Health & social care integration • Long term conditions • Move away from acute care

24. Thank you… Andrew Powrie-Smith – apowrie-smith@abpi.org.uk