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

Access to health
integrating individual clinical expertise with the best available
external clinical evidence from systematic research when
deciding about the care of individual patients 4 . This approach
has been recognized, also, as a valuable tool for choosing the
best strategies for closing the gap between research and
practice 5 and for improving health care provision, through the
delivery of high-quality care that integrates knowledge
coming from evidence-based medicine and the emerging
discipline of evidence-based management 6 .
A number of barriers exist, however, for getting scientific
evidence into practice. They include many factors beyond the
control of the practitioner and patient, and the process of
linking the outcomes of scientific research with health policy
and clinical care requires addressing all of them in a thorough
manner. A key step in translating the findings of relevant
research into actual benefit to patients is ensuring access of
decision-makers to good quality evidence.
Unexpectedly, the global system of protection of intellectual
property rights has ended up being a barrier not only for
access to drugs, but also a barrier for accessing information
on the efficacy and safety of drugs. The TRIPS Agreement not
only gives patent protection to innovative drugs, but it has
also been understood as protecting from divulgation the
information on efficacy and safety that is submitted to
regulatory authorities, having the status of undisclosed 7 . The
TRIPS agreement states, thus, in its article 39.3:
“Members, when requiring, as a condition of approving the
marketing of pharmaceutical or of agricultural chemical
products which utilize new chemical entities, the submission
of undisclosed test or other data, the origination of which
involves a considerable effort, shall protect such data against
unfair commercial use. In addition, Members shall protect
such data against disclosure, except where necessary to
protect the public, or unless steps are taken to ensure that
the data are protected against unfair commercial use”.
The underlying logic of data exclusivity suggests that it is
an expression of trade-secrets more than patents, as
expression of intellectual property rights 8 . The role of
regulatory authorities in ensuring that the information on
efficacy and safety of drugs is adequately analyzed has been
seriously challenged in the last years 9 . Some authors have
labelled the work of the Food and Drug Administration in
USA, as substandard 10 , and recent disclosure of adverse
events information on drugs such as rofecoxib (vioxx) throws
a cloak of doubt over the capacity of regulatory authorities for
dealing with safety and efficacy information in a secret
manner, and public disclosure of all information concerning
drugs has been demanded. A recent advance on this direction
has been the general agreement on the need of registering
clinical trials, endorsed and supported by the World Health
Organization, the International Committee of Medical Journal
Editors, and even Pharmaceutical Manufacturers 11 . There are
many reasons for endorsing this initiative 12 : a publicly
accessible register would help funding agencies in deciding
where to allocate the money; a register of ongoing research
would help patients interested in participating in clinical trials
identifying suitable options, and a register leading to the
results of research would help both patients and health
professionals accessing comprehensive information on the
safety and efficacy of medical interventions. The success of
initiatives like The Cochrane Collaboration, aiming at
producing periodically updated reviews of all relevant
randomized controlled trials of the effects of health care 13 , rely
critically on public access to all results of research.
Any barrier to public access to the findings of research on
the effects of health care may result, thus, in threats to the
quality of care provided by health services and professionals,
to the effective exercise of autonomy of patients in choosing
the most appropriate treatment for their condition and, in a
more general way, in a threat to the fulfilment of the widely
acknowledged right to the highest attainable level of health.
Barriers arising out of trade agreements and any reward to
non-disclosure of the results of research protection of
intellectual property rights should be identified and
adequately addressed. The effects of the implementation of
the Doha Declaration should go beyond ensuring access to
drugs. They should aim, also, at ensuring access to
information on the efficacy and safety of drugs. Those
conflicts arising out of article 39.3 of the TRIPS Agreement,
preventing public access to research results, threatening the
transparency of regulatory authorities’ processes, and
fostering the non-disclosure of data by pharmaceutical
companies, should be denounced and solved in the spirit of
the general principles recognized by the Doha Declaration in
favour of public health protection. The emphasis on the
creation of mechanisms to implement this Declaration has
been placed, up until now, in ensuring access. The
movement towards free access to the results of biomedical
research, including the creation of trials registries and freeing
the access to peer-reviewed journals in low-income countries,
should consider the existing conflict with extra-patent
intellectual property rights granted to non-disclosed
information on the efficacy and safety of drugs, and the
current confidence crisis on how this information is appraised
by the regulatory authorities. ❏
Rodrigo A Salinas is a physician and neurologist who graduated
at the University of Chile. He holds a Master of Science in Evidence
Based Health-Care (University of Oxford) and a Master of Science
in Health Economics (University of York). He works as a consultant
at the Ministry of Health of Chile and lectures at the Faculty of
Medicine of the University of Chile. He was head of the Medicines
Regulatory Agency of Chile (ISP) between 2002 and 2004, and
former Deputy Undersecretary of Health. Since 2007 he has been
acting as a member of the Advisory Committee on Health Research
of the Pan American Health Organization.
048 ✜ Global Forum Update on Research for Health Volume 4