[Ip-health] Declaration handed to UN High-Level Panel on Access to Medicines

Lotti Rutter lotti.rutter at mail.tac.org.za
Fri Mar 18 04:35:20 PDT 2016


Yesterday we delivered the Johannesburg Declaration - signed by many gobal
civil society organisations - to the UN High-Level Panel on Access to
Medicines, in the pouring rain in Johannesburg. Co-Chair Ruth Dreifuss
accepted the letter.



*The Johannesburg Declaration*

*A civil society declaration on the UN Secretary-General’s High-Level Panel
on Access to Medicines*

*March 17 2016*

The UN system – and governments and people around the world – are poised on
the threshold of a historic opportunity to redress the policy incoherence
and imbalance that exists with respect to health technologies between the
justifiable interests of inventors and trade rules on the one hand and
international human rights law and public health on the other.

A system of financing biomedical research and development that relies upon
the grant of monopolies - and the search for profits through high prices -
produces innovation gaps, inefficiencies, and distortions in the
development of new health technologies, as well as avoidable death and
suffering due to high prices and lack of access to health technologies.

Twenty years ago, the WTO TRIPS Agreement created global standards for
intellectual property that have been used to exclude competitors from
offering more affordable health products. Since then industry and certain
countries defending their interests have relentlessly pursued ever-higher
standards of patent, data/regulatory, trade secret, and other intellectual
property protections through free trade agreements, investment treaties,
diplomatic pressure, misleading technical assistance, litigation and
retaliatory measures.

The UN Secretary-General’s High-Level Panel on Access to Medicines has been
established to consider bold, evidence-based alternatives to the
distortions and excesses of the current system – new mechanisms both for
sustainably incentivizing research and development that focuses on the
health needs of all people *and* for ensuring affordable access to the
benefits of medical advances.

Civil society organizations from around the world write this Declaration to
encourage the High-Level Panel to seize this opportunity to make
path-breaking recommendations for reform and revolution in global and
national systems for supporting research and development of needed health
technologies and for subsequently guaranteeing equitable and affordable
access to safe, efficacious, and well-adapted technologies for all persons,
in all countries, for all health conditions.

Based on a review of the contributions and participation in consultations
held in London and Johannesburg, civil society urges the High-Level Panel
to recognize the following principles and to adopt the following


The human right to health which includes access to and the creation of
essential health technologies is paramount. Although medical innovators,
creators, and researchers are entitled to material and reputation benefit
for their research and development efforts, monopolies that transform into
high prices are not required for the realization of those benefits. The UN
Special Rapporteur in the Field of Cultural Rights recently affirmed that
there is no human right to patent protection, stating, “where patents and
human rights are in conflict, human rights must prevail.’’ Similarly, the
UN Human Rights Council and the Special Rapporteur on the Right to Health
have both affirmed that the right to health supersedes intellectual
property protections.

Medical research should focus on the medical needs of all people, including
the unmet needs of those whose medical conditions have been neglected in
the current system.  Global and national mechanisms should be strengthened
and expanded to track human health needs and to help prioritize research
and development efforts.  At the same time, there needs to be ample support
for research that expands our understanding of biomedical science, building
the scientific foundation for new medical technologies, and for research
that adapts products to the needs of specific populations and locales.

All governments have a duty to invest public resources in basic science and
in medical research and development and to ensure efficient and effective
systems of private research and development as well.  Public funding
whether through grants, contracts, innovation inducement prizes, or other
incentive mechanisms and research subsidies must be adequate, sustained,
and responsive to health needs, and policies should maximize the benefits
to the public.  To the extent possible, and where appropriate, coordination
mechanisms should be established for national, regional, and global R&D

The costs of medical research and development should be delinked from the
price of health technologies. Health technologies should be produced
efficiently and where possible competitively either by the private or
public sector.

Medical research and development should be conducted with maximum
transparency and with meaningful support for open-source and collaborative
efforts. Siloed and secret research, hidden for the purpose of private
benefit, is subject to misrepresentation, wasteful or redundant research
efforts, and unethical experiments, and should therefore no longer be
encouraged or tolerated.

Clinical trials to test the safety and efficacy of medical technologies
should be independently evaluated and conducted to ensure proper research
design, objective weighing of evidence and transparency.  Subject to
measures to protect the privacy of patients, the results of all clinical
trials should be accessible to researchers and the public, in order to
expand access to knowledge and enable the data to be evaluated by others.

Governments have a duty to ensure that all people have equitable and
affordable access to needed health products.  When intellectual property
(especially patents, data/regulatory rights, copyright, and trade secrets)
creates barriers to access knowledge, and limits both the freedom to
innovate and affordable access to health technologies, it (including the
intellectual property related to research platforms, base technologies and
final medical products) must be reformed and progressively eliminated.


We strongly support and echo the recommendations of the Global Commission
on HIV and the Law and of the UN Special Rapporteur in the Field of
Cultural Rights for the UN High Level Panel “to review and assess proposals
and recommend a new intellectual property regime for pharmaceutical
products that is consistent with international human rights law and public
health requirements, and simultaneously safeguards the justifiable rights
of inventors.” We call on the UN High Level Panel to make strong
recommendations in this regard.

Governments must increase their investments in medical research and
development, including basic science, and develop norms and systems that
prioritize R&D towards patient-driven health needs, promote transparency
and coordination of efforts, and ensure affordability and access to

Governments should progressively promote new R&D funding systems that rely
on grants, prizes, and other incentives that delink R&D costs from the
price of medical technologies. To facilitate and accelerate these reforms,
the UN Secretary General should start a process for governments to
negotiate a global R&D agreement to ensure robust levels of R&D funding,
and reform or eliminate incentive systems that use the grant of monopolies.

Governments must ensure transparency in every aspect of the pharmaceutical
market, including but not limited to prices, sales, R&D costs and outcomes.

No country should make TRIPS-plus demands in trade agreements or through
diplomatic or other political pressures.  All existing trade agreements
with TRIPS-plus provisions should be amended or suspended to remove such
provisions.  Similarly, no country should make or continue provisions in
investment agreements that allow investor-state-dispute-settlement with
respect to IP or other investment claims based on health products.  All
existing trade agreements and intellectual property regimes should be
interpreted to prioritize human rights and the right to health and access
to health technologies.

All countries should adopt legally permissible TRIPS flexibilities into
relevant and national and regional law and they should use such
flexibilities to give effect to the obligation to ensure access to medicine
for all. Countries should expand the use or adopt mandatory or presumptive
compulsory licensing provisions for health technologies, and apply such
safeguards to patents, data/regulatory rights, copyright, and trade secrets.

Governments should devise universal access systems that ensure equitable
and affordable access to safe, efficacious, and well-adapted health
technologies for all health conditions. They should ensure that all people
receive the benefits of medical advances.

Signed by:

*Treatment Action Campaign*


*People Living with Cancer*

*Cancer Association of South Africa (CANSA)*

*Advocates for Breast Cancer*

*Cancer Alliance South Africa*

*South Africa Federation for Mental Health*

*NCD Alliance South Africa*




*Initiative for Medicines, Access & Knowledge (I-MAK)*


*Third World Network*

*Treatment Action Group (TAG)*

*ACCESS (France)*

*Delhi Network of Positive People (DNP+) *

*ITPC-South Asia*

*AIDS Access Foundation*

*Thai Network of People Living with HIV/AIDS*

*FTA Watch*

*Positive Malaysian Treatment Access & Advocacy Group (MTAAG+)*

*Knowledge Ecology International (KEI)*

*The Young Professionals Chronic Disease Network*

*The Sunflower Fund*


*Wings of Hope Cancer Support*

*KELIN - Kenya*

*Lotti Rutter*
Senior Researcher
Policy, Communications and Research

Treatment Action Campaign
Tel: 021 487 4515
Cell: 081 818 8493
Skype: lotti.rutter
Twitter: @TAC @FixPatentLaw @lottirutter

*www.tac.org.za* <http://www.tac.org.za/>

More information about the Ip-health mailing list