1. Malebona Precious Matsoso Director General: Health 22 July 2016 AIDS 2016 CONFERENCE Essential Medicines, Intellectual Property and Access

2. What the world looked like in 2000 MDGs were adopted at millennium summit Cost of treatment was 10 000 USD per person per annum Legal action between PMA versus President Nelson Mandela, initiated in 1997 Lack of commitment to treatment Fewer people on treatment in South Africa

3. In today’s costs for the 3.4 million people on ARV treatment in SA, using 10 000 USD costs this would mean – 34 billion USD, – Three times the current health budget which is 11.3 billion USD This means (1) fewer people on treatment (2) no funds for other services, salaries, (3) no funds to run the health services The landscape has changed!!! What it would have looked like?

4. 2001: Doha Declaration adopted by WTO Member states: “We agree that the TRIPS Agreement does not and should not prevent members from taking measures to protect public health. “Affirm that the Agreement can and should be interpreted and implemented in a manner supportive of WTO members' right to protect public health and, in particular, to promote access to medicines for all.” 2003 - 2004: Establishment of international and multilateral initiatives: GFATM, PEPFAR and CHAI in 2003, WHO pre- qualification, USFDA tentative approval 2003 : Commission on Public Health Innovation and Intellectual Property 2006: UNITAID established by Brazil, Chile, France, Norway & UK What changed to make treatment more affordable?

5. What changed to make treatment more affordable ? Continued… 2008: Global Strategy and Plan of Action on Public Health, Innovation and Intellectual Property 2010: Consultative Expert Working Group on Research and Development: Financing and Coordination What changed in South Africa: Solidarity Funding for HIV (PEPFAR, the Global Fund, CHAI, EU, DFID, BMGF, etc) Advocacy for access to treatment (e.g. Civil society, academia & private sector & governments) Put 3.4 million people on ART by end 2015

6. What has been the outcome & impact Public health Impact : – Improved life expectancy from 58yrs in 2009 to 62yrs in 2014 – AIDS deaths in South Africa declined from 410 000 in 2008 to 180 000 in 2014. – Mother-to-Child Transmission at 6weeks was 8% in 2008 and reduced to 1,5% in 2015 Market impact: – Competition landscape: Generic competition Financial impact: – Savings achieved : 53% ARV medicine reduction

7. Is the glass half full or half empty? It is half full

8. But the future may not be as secure as it seems

9. The HIV Challenge Globally 37 million people are HIV positive and need treatment Today, only 17 million people have access to treatment. 3.3 million children living with HIV today but; 32% only receive antiretroviral therapy. Need for innovation: e.g. “ More Fixed-dose combinations that are easy to use” Need for access: Millions are still waiting 9 37 million 17 million have it 17 million have it

10. HIV and TB - “deadly duo” TB remains the leading killer of people with HIV, causing one in three AIDS-related deaths Addressing TB-HIV is crucial to achieving UNAIDS 90-90-90 targets. Early access to ART saves lives from HIV and reduces risk of TB. Undiagnosed and/or untreated TB worsens and accelerates HIV progression. 10

11. Paediatric ARVs market has no incentives for industry. Complexity of paediatric market with different strength and dosing per weight band. In 2015, about 873 000 children estimated to be on ART treatment. In 2015, about 150 000 estimated number of children newly infected with HIV Increase access to vaccines even in emergency situations including newer vaccines Only 370 000 of children with TB on treatment out of the estimated 1 million new cases in 2014 Children must not be left behind

12. Growing NCD burden LMICs bear nearly 80% of the burden from NCDs like cardiovascular disease, diabetes, cancer and chronic respiratory diseases More than two thirds of all cancer deaths occur in LMICs But costs of some treatments can be prohibitive, especially for cancer R500 000.00 for a year’s treatment of Trastuzumab for breast cancer; R396 613.00, for colorectal cancer; R960 000.00 for metastatic melanoma; A recent found that cost of cancer care in South Africa was set to rise at up to 10.5% annually until 2020

13. 13 But gaps remain and a future of secure access to medicines is still a journey

14. Triple burden of resistance Resistance to Antibiotics, ARVs with a need for second generation ARVs, MDR- and XDR-TB 1.Tuberculosis: – Two new drugs to treat tuberculosis—the first in over 50 years, were conditionally approved for use. – Only 2% of the 150,000 people who need them have access 2.Antiretrovirals: – The cost of 2 nd and 3 rd line treatment often many times more expensive 3.Antimicrobial resistance is an “intractable global problem” we need a sustainable solution to fight AMR

15. Public health Emergencies WHO has a pooled R&D Fund housed within The Special Programme for Research & Training in Tropical Diseases (TDR) Established Global Blueprint for R&D preparedness and rapid research response Global Blueprint will be helpful for future public health emergencies & avoid the experiences of Ebola & Zika 15

16. 16 Next steps: bold solutions to the problem of new drug development

17. Triple-P approach and De-linkage 1.Triple-P approach (Push-Pull-Pool) for Tuberculosis – Push--upfront funding to finance R&D activities innovative financing should be considered (i.e. through grants) – Pull--- incentive schemes should be explored – Pool- patent pool through pooling and collaborative approaches 2.De-linkage for Antimicrobial resistance – In the de-linkage model, companies would be rewarded for R&D by other means. – Removes the incentive for industry to boost sales in ways which may encourage overuse or misuse

18. Address fixed dose combinations (including paediatric formulations)  Patented by A Patented by B Patented by C Patents on a full HIV treatment can be held by different patent holders making it difficult to develop a pill that brings together various active ingredients Licensing can be a way to address this challenge by pooling all patents needed for developing more affordable combination pills Patented, but licensed to MPP Patented, but licensed to MPP Patented, but licensed to MPP

19. South Africa’s IP Consultative Framework Inter-Ministerial Committee on IP: – Government co‐ordination and policy coherence – IP rights that responds to South Africa’s unique innovation and development dynamics Strategy – immediate domestic review, such as: – Substantial Search and Examination (SSE) - To ensure that patentability criteria are observed while at the same time avoiding backlogs; – Patentability Criteria: Articles 7 and 8 give WTO members the flexibility to implement and interpret the TRIPS patentability 19

20. … continuation – Patent opposition – Affording third parties an opportunity to bring their resources to bear and present relevant information to patent examiners in an opposition process – Disclosure of requirements - An applicant for a patent shall disclose the invention in a manner sufficiently clear and complete. – Parallel importation – Governed by 1997 amendments to the Medicines and Related Substances Act 101 of 1965 (Medicines Act) – Voluntary licensing – ensure that IPRs do not unduly restrict access to essential innovations – Compulsory licensing - 20

21. Opportunities Sustainable Development Goal 3 adopted: Principle of universality includes universal health coverage, and treatment in all countries Ambitious treatment targets, 90-90-90 Recognition and momentum around new models to drive innovation for certain diseases (MDR TB, NTDs Paediatric formulations, public health emergencies and AMR) Prioritisation based on need, Financing and coordination

22. Opportunities and Challenges But significant political and financial commitment is urgently needed to make any of our targets or ideas a reality – Where the collaboration of public, private and civil society partners will be essential – Let’s not miss the opportunity of Durban 2016 to deliver on these urgently needed commitments.

23. 23 The Long Walk to Freedom The Long Journey Towards Access can be shortened for the benefit of those in need