HEALTHCARE IN THE DEVELOPING WORLD - THE ROLE OF INTELLECTUAL PROPERTY. ODI: 12 February 2003

Transcription

1 HEALTHCARE IN THE DEVELOPING WORLD - THE ROLE OF INTELLECTUAL PROPERTY ODI: 12 February 2003

2 KEY QUESTIONS What role does IP play in the development of new drugs and vaccines for the developing world? Is IP a barrier to access to medicines?

3 DEVELOPING WORLD DISEASE (DDW) R&D: GSK S EXPERIENCE One of the largest portfolios of medicines for DDW Only company involved in R&D for both the prevention and treatment of HIV/AIDS, TB and malaria Around 30 projects and programmes of relevance to developing world Diseases of Developing World Unit Dedicated DDW R&D facility - Tres Cantos

4 IP AND R&D OF MEDICINES AND VACCINES FOR DDW Patents stimulate and underpin the R&D of new medicines and vaccines - no patents, no cures It is clear that to increase R&D expenditure on neglected diseases will require a continued commitment for protection of intellectual property. UK HLWG Report We need new medicines and vaccines Absence of IP will reduce incentive to undertake R&D IP alone will not guarantee R&D - it requires IP and a market

5 MEETING THE CHALLENGE OF R&D FOR DDW Traditional business model does not apply for DDW - no market, no return to incentivise private sector Public sector lacks necessary expertise A new partnership model is essential - PPPs

6 THE BENEFITS OF PPPs Private sector - brings technological, development, manufacturing and distribution expertise Public sector partners - help fund development costs and ensure that medicines get to people who need them Partnership approach encourages R&D and accelerates the product s uptake

7 THE CONCEPT IN ACTION LapDap (anti-malarial) ACW 135 vaccines (meningitis) Global Alliance for Vaccination and Immunisation Medicines for Malaria Venture MSF DNDi Leishmaniasis, African Tryp and Chagas next? Concentrate on the solution, not a perceived problem

8 IS IP A BARRIER TO ACCESS TO MEDICINES? >95% of drugs on WHO EML are not patented, but 30% of those who need them do not get them.

9 PATENTS ON EDL DRUGS IN AFRICA 18 countries - no EDL drugs patented (out of 308) 23 countries - 1 EDL drug patented (out of 308) 9 countries - 2 EDL drugs patented (out of 308) 1 country - 3 EDL drugs patented (out of 308)

10 IS IP A BARRIER TO ACCESS TO MEDICINES? >95% of drugs on WHO EML are not patented but 30% of those who need them do not get them. 3 million deaths p.a. caused by TB and malaria, but drugs are not patented

11 STATUS OF COMMUNICABLE DISEASES IN AFRICA DISEASE ANNUAL DEATHS # OF INFECTIONS % OF POSSIBLE PATENTS COST TO TREAT Malaria 472, million annual cases 4.5% $1 per patient course Diarrheal Disease 394, million (global) 0% Cents per treatment Tuberculosis 229, million annual cases 0.5% $11 per patient (6 month supply) Trypanosomiasis 35, ,000 0% Drug donated HIV/AIDS 1,700, million 21.6% $1-3 per day

12 IS IP A BARRIER TO ACCESS TO MEDICINES? >95% of drugs on WHO EML are not patented but 30% of those who need them do not get them. 3 million deaths p.a. caused by TB and malaria, but drugs are not patented Most ARVs not patented in most of Africa, but most patients who need them do not get them

13 ARV PATENTS IN 53 AFRICAN COUNTRIES Regimen d4t+ddi+ind DHHS guidelines Strongly recommended d4t+ddi+ind+rit Strongly recommended d4t+3tc+ind AZT+3TC+NEL d4t+ddi+efv 3TC+d4T+NEV ddi+d4t+nev Strongly recommended Strongly recommended Strongly recommended Recommended as alternative Recommended as alternative zero patents 51 (96.2%) 51 (96.2%) 19 (35.8%) 15 (28.3%) 52 (98.1%) 18 (34.0%) 28 (52.8%) <1 patent 52 (98.1%) 52 (98.1%) 52 (98.1%) 25 (47.2%) 52 (98.1%) 30 (56.6%) 52 (98.1%) Source: Attaran & Gillespie-White (2001). Journal of the American Medical Association 286:

14 IS IP A BARRIER TO ACCESS TO MEDICINES? >95% of drugs on WHO EML are not patented but 30% of those who need them do not get them. 3 million deaths p.a. caused by TB and malaria, but drugs are not patented Most ARVs not patented in most of Africa, but most patients who need them don t get them No patents in India

15 INDIA: A CASE STUDY Estimated HIV+ Estimated AIDS cases 3,800, ,000 Estimated patients on HAART Patents on ARV drugs Local pharmaceutical plants Indian companies producing ARVs ARVs exported by Indian companies less than 20, 000 around 3.5% 0 22, or more 2 10 or more 2 1. UN/WHO Press Reports

16 CONCLUSIONS Focus on IP as a barrier is misleading and counterproductive The causes of lack of access are complex and multifaceted Poverty is key Required response - all sectors of global society must work together in new kinds of partnerships to find new solutions

17 SHARED RESPONSIBILITIES - WHAT IS GSK DOING? R&D into diseases of the developing world Community Partnerships that promote effective healthcare in the developing world Not for profit pricing All ARVs and anti-malarials 63 countries 120 Supply Arrangements in 50 countries 3x increase in shipments in 2002 Pilot programme for wider product range Innovative solutions - voluntary licensing

18 Shared Responsibilities Funding agencies NGOs (Non governmental organizations) Developed country governments IMPROVED ACCESS TO MEDICINES Multilateral agencies (UN, WHO, WTO, World Bank, etc.) Developing country governments Media Pharmaceutical industry

19 ACCESS - MUCH ACHIEVED Global Fund established AAI treatment numbers increasing WHO Treatment Guidelines and prequalified suppliers list Progress on the 3P framework - UK High Level Working Group, EU Regulation Doha Declaration Possible $10bn from US.BUT MUCH MORE TO DO

20 ACHIEVING FURTHER PROGRESS IP is an easy target But it is crucial to development of new medicines and vaccines There are many factors affecting access Focus on the real causes and the real solutions

21 Intellectual property protection is key to bringing forward new medicines, vaccines and diagnostics urgently needed for the health of the world's poorest people. Kofi Annan UN Secretary-General