Access to medicines challenges in Europe: What is wrong and the way forward Presented by: Rohit Malpani Director of Policy & Analysis, Access Campaign MSF Access Campaign

Médecins Sans Frontières (MSF), founded in 1971, is an international, independent, medical humanitarian organization that delivers emergency aid in 70 countries. MSF in Greece has had operations in Greece since 1991 and currently works with migrants at detention facilities in the north and has established a project in the Athens city centre that focus in particular on vulnerable people. MSF’s Access Campaign works to promote increased access to life-saving medicines, vaccines and promote increased R&D of new medical tools that meet patient needs. About Médecins Sans Frontières (MSF)

Generic Competition and HIV Treatment Scale-Up $10,400 $2700

Impact of patent monopolies

Extreme disparity between cost of manufacturing and product price Sofosbuvir – new Hepatitis C drug recently approved by the European Medicines Agency and Food and Drug Administration In combination with other drugs, successfully treat Hepatitis C in weeks depending on genotype. Cost of manufacturing of Sofosbuvir for 12 week course: Between 50 and 100 Euros Estimated price in the United States and EU for 12 week course: Approximately 60,000 Euros MSF Access Campaign

Tiered pricing: best strategy? Some major weaknesses: a)Price: reductions not reliable, not lowest, not sufficient b)Arbitrary: categories, products and price premiums c)Lack of transparency d)Whose responsibility: firms or governments? Source: Moon S, Jambert E, Childs M, von Schoen-Angerer T “A ‘win-win’ solution?: A critical analysis of tiered pricing to improve access to medicines in developing countries.” Globalization and Health 7:39. doi: / Available:

MSF Access Campaign Source: MSF Untangling the Web of Antiretroviral Price Reductions, 15 th Edition, July 2012 The most affordable second-line regimen is still twice as expensive as the WHO recommended first-line regimen The price of a third-line regimen is more than 14 times higher than the recommended first-line Tiered pricing for ARVs: Treatment time bomb Source: MSF Untangling the Web of antiretroviral Price Reductions, 15 th Edition, July 2012

GAVI $7 PAHO ~$15 South Africa $20 Macedonia $89 Sources: PAHO Revolving Fund price list, UNICEF Supply Division GAVI Price List, South Africa DoH personal correspondence (7Nov2012), SAGE Presentation (8Nov2012) MSF feedback on price: vaccines too expensive (PCV price per dose comparison) GAVI Alliance Advanced Market Commitment (AMC) PAHO Revolving Fund - $14.24 (PCV10), $16.34 (PCV13) Republic of South Africa Macedonia Greece?

MSF Access Campaign Source: MSF Untangling the Web of Antiretroviral Price Reductions, 15 th Edition, July 2012 Public health safeguards to improve access Range of public health safeguards protected under World Trade Organization rules, including compulsory licensing and tighter patentability rules. India granted its first compulsory license to allow generic production and sale of Sorafenib (cancer medicine). Ensure patents are only granted for true innovations, not legal innovations. Avoid ever-greening.

MSF Access Campaign Source: MSF Untangling the Web of Antiretroviral Price Reductions, 15 th Edition, July 2012 Public health safeguards to improve access? Bedaquiline (TB): 30,000 Euros in high-income countries, 3,000 Euros in middle income countries. Simeprivir (Hepatitis C): 48,000 Euros in high-income countries. Herceptin (breast cancer): Greek patients must pay a Euros copayment for branded versions of the medicine. November 27, 2013: Generic equivalent of Herceptin approved in India.

MSF Access Campaign Source: MSF Untangling the Web of Antiretroviral Price Reductions, 15 th Edition, July 2012 European Commission: Where is the commitment to access? Pressure imposed on developing countries that employ compulsory licensing and other safeguards to ensure affordable treatment. Supports tiered pricing as the solution to access. Negotiating free trade agreements that would limit ability of EU Member States to use public health safeguards. European Union Competition Commission: Anti- competitive intellectual property strategies cost EU consumers 2 billion Euros between 2000 and 2007.

MSF Access Campaign Source: MSF Untangling the Web of Antiretroviral Price Reductions, 15 th Edition, July 2012 The way forward Re-thinking the ‘bottom billion’. Full use of safeguards available under global trade rules to manage medicine prices. Don’t tie the hands of EU Member States to improve access to medicines. EU taxpayers should not pay twice for medicines.