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

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,