Access to medicines Elizabeth Holzer, Legal Policy Advisor A global and local - legal and health systems issues

Overview Complex, multidimensional problem Many legal/regulatory factors Political targets (focus on the “enemy” not the problem) International context

NCD Global Action Plan

Access to meds Health System -Level of development -Geographic coverage -Universal coverage/freeAvailability -Available in country -Obtained regulatory approval -Regulated/restricted medicine, eg. controlled substance Cost of medicine Affected by whether the medicine is: -Patented -Government funded -Rational use policies MANY FACTORS AFFECT PATIENTS’ ACCESS TO MEDICINES

health systems workforce supply chains rational prescription National/international drug control systems IP important – but it’s not just about IP patient adherence safety and efficacy pricing policy financing / subsidisation

justification for patents provide incentive / reward for research that ultimately benefits society by promoting innovation that is shared with the public rather than kept secret allows the manufacturer to charge premium prices for the duration of the patent Purpose of patents

whether patent laws achieve the appropriate balance is strongly contested the position varies by product its use its market the cost that goes into its development and by jurisdiction But remember, many essential/basic medicines are off patent Patents for pharmaceuticals – does the system work?

requires WTO members to provide minimum levels of patent protection (at least 20 years), enforceable through the WTO dispute settlement procedure States to provide patent owners with a range of exclusive rights (note transitional periods for developing countries and LDCs) TRIPS – patent protection

TRIPS flexibilities Inherent flexibilities; and Explicit flexibilities (compulsory licenses)

Art 27: Patentable subject matter “1. Subject to the provisions of paragraphs 2 and 3, patents shall be available for any inventions, whether products or processes, in all fields of technology, provided that they are new, involve an inventive step and are capable of industrial application.” TRIPS – patent protection

Art 27: Patentable subject matter “2. Members may exclude from patentability inventions, the prevention within their territory of the commercial exploitation of which is necessary to protect ordre public or morality, including to protect human, animal or plant life or health or to avoid serious prejudice to the environment, provided that such exclusion is not made merely because the exploitation is prohibited by their law. TRIPS – patent protection

Art 27: Patentable subject matter “3. Members may also exclude from patentability: (a) diagnostic, therapeutic and surgical methods for the treatment of humans or animals; (b) plants and animals other than micro-organisms, and essentially biological processes for the production of plants or animals other than non-biological and microbiological processes.” TRIPS – patent protection

Further developments

disagreement between USA / EU and Brazil, India, Mexico and other G77 members long-running battle – pharma, US and EU trying to limit flexibilities to HIV/AIDS, TB and malaria Political Declaration on NCDs

outcome: a “challenge of epidemic proportions” affirmed the full use of TRIPS flexibilities for NCD medicines but Doha Declaration not mentioned Political Declaration on NCDs

Novartis refused a patent for Glivec – treatment for chronic myeloid leukemia Indian law: patent only granted for new forms of known medicine if change significantly improved therapeutic efficacy generic companies supplying at US$ a month compared with branded price of US$2,478 High profile cases in India

compulsory licence issued for a treatment (brand name Nexavar) for kidney and liver cancer on grounds that Bayer had not priced drug at level affordable to all Indian patients and had not ensured availability of sufficient quantities price dropped from over US$5500 a month to $175 and then $125 High profile cases in India

Eli Lilly v Canada Canadian court’s invalidated two patents (following fair and full hearings with appeals) Lilly is arguing: Canadian patent law (in general) is discriminatory against pharmaceutical patents, in breach of NAFTA and TRIPS; It’s investment has been expropriated through the invalidation of its patents The claim = $500 million ISDS and access to medicines

regional trade agreements bilateral trade agreements TRIPS-Plus

data exclusivity provisions (reportedly 5 years, 8 or 12 for “biologics”) generic manufacturers to duplicate clinical trials or delay until exclusivity period end evergreening – new uses – even if not enhanced efficacy extension of term to compensate for delays in approval PBS type – reimbursement / subsidies TRIPS Plus

Links Reports and Publications: Hogerzil and Liberman et al 'Promotion of access to essential medicines for non-communicable diseases: practical implications of the UN political declaration'Hogerzil and Liberman et al 'Promotion of access to essential medicines for non-communicable diseases: practical implications of the UN political declaration', Lancet (2013) Jonathan Liberman, Implications of International Law for the Treatment of Cancer: the Single Convention on Narcotic Drugs and the TRIPS Agreement, Public Health (2011) Links: World Health Organization, Access to Non-Communicable Diseases Medicines World Heath Organization, Trade, Intellectual Property Rights and Access to Medicines World Trade Organization, Millennium Development Goals: Access to MedicinesWorld Trade Organization, Millennium Development Goals: Access to Medicines WHO Global Action Plan for the Prevention and Control of Non-Communicable Diseases Global Monitoring Framework on Non-Communicable DiseasesGlobal Monitoring Framework on Non-Communicable Diseases,