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NCD Global Action Plan
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Access to medicinesAccess 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 medsAccess to medsHealth System Health System -Level of development-Geographic coverage-Universal coverage/free
AvailabilityAvailability-Available in country-Obtained regulatory approval-Regulated/restricted medicine, eg. controlled substance
Cost of Cost of medicinemedicine
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$124-174 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', 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 MedicinesWorld Heath Organization, Trade, Intellectual Property Rights and Access to MedicinesWorld Trade Organization, Millennium Development Goals: Access to Medicines WHO Global Action Plan for the Prevention and Control of Non-Communicable Diseases 2013-2020 Global Monitoring Framework on Non-Communicable Diseases,
