1. Strategies to increase access to high priced medicines and vaccines: lessons, new challenges and opportunities Judit Rius Sanjuan U.S. Manager & Legal Policy Adviser, Access Campaign of Doctors Without Borders/Médecins Sans Frontières (MSF) Regional Meeting on High Cost and Strategic Medicines Santiago, Chile September 02-03, 2015

3. MSF Access Campaign MSF Access Campaign (1999) MSF challenges faced when treating & vaccinating patients - medical tools (drugs, vaccines. Diagnostics) are: Unaffordable  High prices Unavailable or Unadapted  Research and development do not target medical needs of poor patients (e.g. no test of cure for chagas, treatment for DR-TB, ebola, heat stable vaccines..)

4. MSF Access Campaign Affordability: Competition enables treatment scale up for ARVs

5. HIV/AIDS Treatment = Competition  Lessons Learned –  Price Negotiation is good but it has its limits - Best practices: Joint/Pool procurement & Price transparency (MSF Untangling the Web of ARVS prices, 2014 17 edition)  Medicines are not high cost, they are high priced  Regional and across regions solidarity-strategies better than bilateral government negotiations  Generic competition is the game changer - Need to deal with patents and other IP monopolies – TRIPS flexibilities used by Brazil/Thailand/India and other MICs opened the global generic market  Outcomes:  Generic competition has brought the price of first line ART down by 99 percent, from over $10,000 in 2000 to under $100 today.  Creation of Global Fund/PEPFAR and Government funded treatment programs  In 2015, more than 15 million people have access to HIV/AIDS medicines

6. World is changing: Newer HIV/AIDS medicines more expensive Source: MSF Untangling the Web of antiretroviral Price Reductions, 15 th Edition, July 2012 Demand and need for second-line HIV treatments is growing fast Most of the newer medicines patent protected and less competition Less price transparency especially for MICs – (2014- 17 edition was last MSF UTW) MSF Access Campaign

7. The Right Shot (MSF 2 nd edition, Jan 2015) Report on vaccine price information: 1,500 data points from 16 key vaccines across 13 countries. Key findings:  From 2001-2014, price of the vaccines package has increased 68-fold, and that’s only when using lowest global prices (GAVI prices, not accessible to most countries).  New vaccines without competition (PCV, HPV, rotavirus) account for 86% of package cost. PCV vaccine accounts for nearly half of the basic vaccine package.

8. MSF Access Campaign World Bank categorization has no relation to public health or population socioeconomic data/needs. 75% poorest live in MICs. Classification as MICs triggers a range of negative consequences from the perspective of access to medical innovation and treatment. –Loss of overseas development and global health funding/ assistance. –Higher prices for medicines and vaccines under tiered pricing schemes and exclusion from patent voluntary licenses and other companies “access strategies” designed for low income countries. –Immense pressure to adopt strict levels of intellectual property protection (TRIPS Plus) and to not use public health legal safeguards to promote generic competition. Example: TPP and US & EU pressure to Indian Patent Law. Concerns with middle-income country (MICs) classification

9. MSF Access Campaign TPP endangers future affordable access to medicines The TPP is a regional trade agreement under negotiation. It currently involves the US, Chile and 10 other countries, encompassing more than half a billion people and 40% of world GDP TPP is slated for expansion and touted as a standard-setting model for 21st century trade agreements. Leaked texts show the US is demanding aggressive intellectual property provisions at the expense of public health. These provisions will raise the cost of medicines and limit generic competition. PhRMA has several targets: data exclusivity for biologics, secondary patents, strong patent enforcement, weaken TRIPS flexibilities

10. Prices of HPV vaccine: Unrelated to country income For example, this upper-middle income country pays $45.59 per dose …While this high- income country pays $23.21 per dose Weighted Average Price by Manufacturer for HPV 1-Dose World Health Organization. “Vaccine Product, Price and Procurement.” [Cited 2015 Aug 31]. See:http://apps.who.int/immunization/vaccineprice/en /Navigation/Load?menu=1096&sub=1082

11. MSF Access Campaign

13. High priced medicines is a global problem: growing concern in the USA “1,000 USD a pill” Gilead price for Sofosbuvir & several cancer products over 100,000 USD have transformed into public concern from civil society, cancer doctors, hospitals, payers-insurers, AARP, Congress and others. Strategies being considered: Several US government programs to have faculty to negotiate prices, value-based economic evaluations, Congressional pressure to Gilead to lower price, White House proposal to reduce data exclusivity for biologics and limit evergreening, compulsory license for USG veteran programs… Momentum for Cost Transparency – Several bills considered at State & Federal Congress and company shareholders resolutions to require disclosure of cost, value, pricing and R&D costs by pharmaceutical companies

14. High prices of Hepatitis C medicines limiting patient access Gilead global prices for (sofosbuvir or combos): US $900 to $95,000 It is a high priced medicines, not a high cost medicine - Estimated manufacturing costs: $101 per 12-wk course (sofosbuvir) – Estimated R&D costs (As little as $300 million). Goal: universal coverage, but expensive tiered priced medicines (in developing countries from 900 USD to 12,000 USD) currently rations access to medicine to the sickest or the richest. Gilead has voluntary licenses schemes for approximately 101 developing countries, but it excludes 38 middle income developing countries and millions of people living with HCV. 70% of people wit HCV live in MICs.

15. MSF Access Campaign Several governments, generic companies and civil society already pursuing TRIPS flexibilities: patent oppositions / compulsory license / competition law Already competition (and threat of competition) from multiple manufacturers is indicating a downward trend for the Gilead prices Several supplies - Available from a generic company in India at approx $567/ 12-wk course Several countries, (ie India, Pakistan and Egypt), can access low-cost, generic versions of sofosbuvir, but the number of countries able to do so is limited. Additional suppliers for several DAAs are on the verge of entering the market. PAHO Governments can access several HCV generic suppliers if no IP barrier exists. If IP barrier exists, countries should request Gilead to be added to geographical scope of the voluntary license + use TRIPS flexibilities to ensure access to generic suppliers Generic competition can drive down prices

16. HCV generic suppliers MSF Access Campaign

17. A different approach to R&D is needed  The current system is unsustainable and not delivering patient-needed innovations  We need to archiving both innovation and access  Goal: De-link or separate paying for the cost of health innovation from the price of the products to ensure affordability/accessibility up front when funding R&D

19. MSF Access Campaign An opportunity - WHO CEWG Report “On balance we consider that the time has come for Member States to begin a process leading to the negotiation of a binding agreement on R&D relevant to the health needs of developing countries.“ Elements of R&D reform: Increase government funding, public-priority setting, coordination, incentives that ensure delinkage, affordability and open innovation, building R&D and manufacturing capacity in developing countries

20. 3P TB: Creating an Open Innovation Framework - Push, Pull, Pool http://www.msfaccess.org/spot light-on/3p-project-new- approach-developing-better- treatments-tb An MSF Innovation proposal

21. MSF Access Campaign The high prices of medicines is a growing and global concern Governments and civil society have tools they can use to reduce prices and increase patients access Price negotiations need to be strengthened with a variety of tools - Governments and civil society need to have legal and political tools to deal with monopolies – price, manufacturing cost and R&D transparency / economic evaluations / intellectual property management and TRIPS flexibilities/ Competition law … Political collaboration between countries Countries can and must adopt new alternative approaches that ensure both innovation and access, that reform the broken model of R&D, by de-linking the cost of R&D from the price of products. Next WHA 2016 when WHO CEWG report will be reconsidered is a key opportunity Summary

22. August 2015: Set innovation free - Time to fix the patent system MSF Access Campaign Gracias ! Thank you! judit.rius@newyork.msf.org www.msfaccess.org