Combining health and social protection measures to reach the ultra ...

Access to health
Open access to research protocols
and results: intellectual property
and the right to health
Article by Rodrigo A Salinas
The human right to the highest attainable standard of
health requires for its fulfilment access to good quality
health care. Equitable access to health technologies,
ranging from health promotion activities to drugs and complex
interventions, is a key part of the care provided. An equally
important requirement for ensuring good quality care,
however, is access to information on the efficacy and safety
of these technologies, coming from scientific research. Any
barrier hampering access to this information should be
considered as dangerous as those barriers preventing access
to drugs and other health technologies. The Doha Declaration
recognized in 2001 that trade-related intellectual property
rights should not conflict with the right to protect public
health. Conflict among these rights, however, affects not only
access to drugs, as emphasized by those mechanisms
created to implement the Declaration, but also access to the
information on the efficacy and safety of these drugs,
particularly by those provisions contained in article 39.3 of
the Trade-Related Aspects of Intellectual Property Rights
(TRIPS) Agreement that reward the non-disclosure of the
findings of medical research.
The right to the highest attainable standard of health has
been recognized as a human right in the International
Covenant on Economic, Social and Cultural Rights, adopted
and opened for signature and ratification by the General
Assembly of the United Nations (UN) in December 1966. In
a general comment issued by the Economic and Social
Council of the UN in 2000, it is explicitly stated that a
substantive issue arising in the implementation of this right is
the provision of equal and timely access to basic preventive,
curative, rehabilitative health services, regular screening
programmes and appropriate treatment of prevalent diseases
and disabilities.
The new global deal on intellectual property rights, arising
out of the Uruguay Round of Multilateral Trade Negotiations
that concluded with the signature of the Agreement on TRIPS,
and the creation of the World Trade Organization (WTO), in
the eighties, has been denounced in many forums as a barrier
for fulfilling this right. The current system of granting patents
for new drugs, considered as crucial for encouraging the
invention of much-needed medicines by the pharmaceutical
industry, has been considered as an obstacle for getting
equitable access to drugs in developing countries 1 . These
concerns and a couple of much publicized cases, such as the
case brought against President Nelson Mandela by the South
African Pharmaceutical Manufacturers Association,
eventually led the WTO to produce the Doha Declaration on
the TRIPS Agreement and Public Health recognizing that:
“…the Agreement can and should be interpreted and
implemented in a manner supportive of WTO members’ right
to protect public health and, in particular, to promote access
to medicines for all” 2 .
Ensuring access to drugs, notwithstanding, is only one
among other requirements needed for fulfilling the right to
good quality health care. A much less explored, but equally
important domain is the need for ensuring access to
information on the efficacy and safety of drugs. Health care,
in order to achieve the desirable outcomes it is supposed to
get, needs not only careful use of technologies that are
applied by health professionals, and provided by health
services, but needs also a responsible and accountable
decision-making process leading to the prescription of a
particular procedure for a particular person. This decisionmaking
process, to be considered a high quality one, needs
timely access to adequate and appropriate information on the
safety, efficacy and effectiveness of the whole menu of
technologies that are available to be prescribed for different
conditions. Good quality information on these domains
comes, in medicine, from methodologically sound and
ethically responsible research. It is reasonable, thus, to
conclude, that the materialization of access to health care as
a human right, needs not only actual access to technologies
but also adequate and timely access to information on those
domains that allow appropriate decisions to be made at the
points where these decisions occur.
Practising medicine and allied health professions in the
21st century, would be unthinkable without access to good
quality data on the efficacy, effectiveness, and safety of health
technologies, ranging from health promotion activities to
highly sophisticated medical devices. As part of this move
towards explicit use of scientific data, evidence-based
medicine has been widely accepted as a new paradigm for
teaching and practising medicine, de-emphasizing intuition,
unsystematic clinical experience and pathophysiologic
rationale as sufficient grounds for decision-making 3 , and
Global Forum Update on Research for Health Volume 4 ✜ 047