[Ip-health] TAC & SECTION27 statement on UN HLP report

Lotti Rutter lotti.rutter at mail.tac.org.za
Wed Sep 14 13:44:28 PDT 2016


UN REPORT STRENGTHENS CASE FOR PATENT LAW REFORM IN SA AND OTHER DEVELOPING
COUNTRIES

*http://tac.org.za/news/un-report-strengthens-case-patent-law-reform-sa-and-other-developing-countries
<http://tac.org.za/news/un-report-strengthens-case-patent-law-reform-sa-and-other-developing-countries>*


-        We urge all governments to urgently adopt and act on UN
recommendations to safeguard right to health.
-        South Africa must show the way by leading developing countries,
especially the BRICS, the SADC and the AU, in adopting and building on the
recommendations

*JOHANNESBURG, 14th SEPTEMBER 2016*: The Treatment Action Campaign (TAC)
and SECTION27 welcome the release of the United Nation Secretary General’s
High-Level Panel Report on Access to Medicines. This UN report makes a
number of important recommendations regarding how society pays for
medicines and for the research and development of new medicines. While we
welcome several recommendations, they should be viewed as a minimum
standard that need to be built upon in order to fully remedy the failures
in the current patent system and ensure everyone has access to the
medicines they need.

We urge the South African government, and all other governments to engage
with the recommendations of the UN High-Level Panel. In particular, we urge
the South African Cabinet to urgently discuss the report and consider the
adoption of its recommendations. Access to existing medicines and the
development of new medicines is literally an issue of life and death for
thousands of people. We ask governments to treat it as such and accordingly
to give this report the priority attention it deserves. In South Africa,
the government has a constitutional duty to take reasonable legislative and
other measures, within its available resources, to achieve the progressive
realisation of the right of access to healthcare services.

Below we highlight some of the key recommendations and their implications:

1.     The report recommends that countries make full use of health
safeguards available under international law (TRIPS flexibilities). It
makes particularly strong recommendations on amending laws to avoid patent
ever-greening and to allow for more workable compulsory licensing
provisions. These recommendations are in line with the objectives of the
Fix the Patent Laws campaign (of which TAC and SECTION27 are members).
South Africa has delayed the law reform process to make use of these public
health safeguards by over 10 years, despite repeated calls by TAC,
SECTION27 and other organisations concerned about public health in South
Africa.

We refer to two key recommendations that we urge the South African
government to adopt and act on urgently:

*“WTO Members should make full use of the policy space available in Article
27 of the TRIPS Agreement by adopting and applying rigorous definitions of
invention and patentability that are in the best interests of the public
health of the country and its inhabitants. This includes amending laws to
curtail the ever-greening of patents and awarding patents only when genuine
innovation has occurred.” *

and

*“Governments should adopt and implement legislation that facilitates the
issuance of compulsory licenses. Such legislation must be designed to
effectuate quick, fair, predictable and implementable compulsory licenses
for legitimate public health needs, and particularly with regards to
essential medicines. The use of compulsory licensing must be based on the
provisions found in the Doha Declaration and the grounds for the issuance
of compulsory licenses left to the discretion of governments.” *

Unfortunately the report fails to make concrete and actionable proposals to
put a stop to all TRIPS plus measures that undermine access to medicines in
trade agreements. To properly redress this ongoing threat, governments must
build on what is contained in the report and reject all TRIPS plus measures
in trade agreements.


2.     The report also acknowledges that countries that attempt to use
these WTO-approved legal safeguards often face severe pressure from certain
developed  countries and the pharmaceutical industry. Such an
acknowledgement in a UN report is remarkable. The report states as follows:

*“Many governments have not used the flexibilities available under the
TRIPS Agreement for various reasons ranging from capacity constraints to
undue political and economic pressure from states and corporations, both
express and implied. Political and economic pressure placed on governments
to forgo the use of TRIPS flexibilities violates the integrity and
legitimacy of the system of legal rights and duties created by the TRIPS
Agreement, as reaffirmed by the Doha Declaration. This pressure undermines
the efforts of states to meet their human rights and public health
obligations.”*

Unfortunately the report stops short of recommending bold punitive measures
against countries who exercise such undue pressure. Building on the
report’s recommendation it should be mandated that all UN Member States
should reaffirm their commitment to the anti-retaliation principle and
sovereignty of WTO Members in complying with TRIPS as reflected in Article
1.1 of the TRIPS Agreement. Unilateral retaliation against countries using
or intending to use TRIPS flexibilities should be deemed a violation of the
TRIPS Agreement.


3.     The report makes important recommendations regarding neglected areas
of medical research and recognises that the patent system has failed to
incentivise sufficient R&D for diseases like tuberculosis (TB being the
infectious disease that currently kills most people on the planet –
approximately 1.5 million people per year). It states that *“It is
imperative that governments increase their current levels of investment in
health technology innovation to address unmet needs.” The report doesn’t
just argue for greater investment, but also for changes to the ways in
which governments invest. These include ensuring that publicly funded
research is licensed on terms more sensitive to public health needs and
supporting innovation models such as innovation inducement prizes and the
pooling of intellectual property.*


4.     We welcome the reports strong endorsement of a binding R&D
convention or agreement. We consider such a convention to be the most
realistic prospect for solving the ongoing crisis of underinvestment in R&D
for diseases impacting mostly poor people. It recommends as follows:

*“Building on current discussions at the WHO, the United Nations
Secretary-General should initiate a process for governments to negotiate
global agreements on the coordination, financing and development of health
technologies. This includes negotiations for a binding R&D Convention that
delinks the costs of research and development from end prices to promote
access to good health for all. The Convention should focus on public health
needs, including but not limited to, innovation for neglected tropical
diseases and antimicrobial resistance and must complement existing
mechanisms.”*

We urge the South African government to take a leading role  in the
negotiation of and establishment of such a binding  R&D convention.


5.     The report makes a number of excellent and wide-ranging
recommendations regarding R&D transparency. At present pharmaceutical
companies share very little information about their R&D spending. This lack
of transparency is particularly problematic given the extremely high prices
being charged for many new and old medicines. A number of states in the
United States are already considering legislation relating to transparency
of pharmaceutical R&D and/or price-setting. The report recommends as
follows:

*“Governments should require manufacturers and distributors of health
technologies to disclose to drug regulatory and procurement authorities
information pertaining to: (1) the costs of R&D, production, marketing and
distribution of health technology being procured or given marketing
approval with each expense category separated; and (2) any public funding
received in the development of the health technology, including tax
credits, subsidies and grants.”*

We urge legislators in South Africa and all other countries to adopt and
act on this recommendation in the interests of public health and to take
into account this information for the purposes of price-setting.

It also makes the following welcome recommendations regarding clinical
trials transparency. The required legal and/or regulatory steps must
urgently be taken to ensure that the South African Health Products
Regulatory Authority can implement these recommendations. (TAC is a member
of the #AllTrials campaign which advocates for the results of all clinical
trials to be made public)

*“To facilitate open collaboration, reconstruction and reinvestigation of
failures, governments should require that study designs and protocols, data
sets, test results and anonymity-protected patient data be available to the
public in a timely and accessible fashion. Those undertaking clinical
trials must not prevent researchers from publishing their findings.”*

and

*“Governments should require that the unidentified data on all completed
and discontinued clinical trials be made publicly available in an easily
searchable public register established and operated by existing mechanisms
such as the WHO Clinical Trials Registry Platform, clinical trials.gov
<http://trials.gov> or in peer reviewed publications, regardless of whether
their results are positive, negative, neutral or inconclusive.” *


6.     The report recognises that health and human rights considerations
have often been undermined in the development of trade agreements. The
report makes a number of recommendations to help address this imbalance. We
recommend that the South African government and all other governments adopt
and acts on the following recommendation as soon as possible:

*“Governments must review the situation of access to health technologies in
their countries in light of human rights principles and States' obligations
to fulfil them, with assistance from the Office of the United Nations High
Commissioner for Human Rights (OHCHR) and other relevant United Nations
entities. The results of these assessments should be made publicly
available. Civil society should be financially supported to submit their
own shadow reports on innovation and access to health technologies. Such
national reviews should be repeated at regular intervals.”*


While a number of the less ambitious things TAC, SECTION27 and our allies
internationally argued for are included in the report, many important
proposals in relation to human rights, the failings of the patent system
and reform of the IP regime have not been included. In particular we call
for urgent discussion within UN forums on a new IP regime for
pharmaceutical products that is consistent with international human rights
law and public health requirements, while at the same time safeguarding the
justifiable rights of inventors. We stand by the submissions we made and
endorsed and will continue to advocate for an alternative to the current IP
regime that prioritises human rights above all.

We understand that the panel was forced into making certain compromises –
some at the last minute. For example we are aware that a minority of panel
members rejected at the final hour a recommendation for the near automatic
issuance of compulsory licenses on essential health technologies. While
these compromises are disappointing, this is not unexpected given that both
the multinational pharmaceutical industry and generic medicines industry
had representation on the panel and ample opportunity to make submissions
to the panel and influence its work. While this has led to some
disappointing compromises, it at least shows consensus on the moderate
recommendations included. We urge the rapid adoption of these
recommendations.

Furthermore,  the report opens the door for South Africa and the BRICS
countries to build on this momentum and advocate for more fundamental
change, including the renegotiation of the TRIPS Agreement. We urge our
government to make full use of this window of opportunity.

In February this year TAC and SECTION27 made three submissions to the panel
and endorsed an additional four made by partner organisations. We also held
a demonstration when the panel visited South Africa for public hearings in
March. At that demonstration we handed the panellists the Johannesburg
Declaration –a joint declaration by 26 organisations from across the world.
Many of the demands of the Johannesburg Declaration has not been met. For
more on the shortcomings of the report we urge people to read the
commentary by the panellists Jorge Bermudez, Winnie Byanyima and Shiba
Phurailatpam (annex 1 to the report).


Demonstration at Department of Trade and Industry on 27th September

We repeat our call for the South African government to engage with this
report at all levels and to adopt its recommendations. It is the people who
are paying the price for government’s ongoing failure to reform our
outdated patent laws. While we are aware that an inter-ministerial
committee has been established to consider patent law reform, we remain
concerned about the lack of buy-in from different government departments
and their Ministers. This is a matter that needs to be dealt with at
Cabinet level. Delays over the last ten years have shown that law reform
that would ensure better access to medicines has not been a priority for
government. This indifference from our elected leaders is unacceptable.

On Tuesday 27th September TAC, SECTION27 and partners will protest outside
of the South African Department of Trade and Industry in Pretoria. We will
ask Minister of Trade and Industry Rob Davies to explain to us why we are
still waiting for law reform 15 years after the signing of the Doha
Declaration. We will hand him a copy of the UN report, our comments on a
Consultative Framework recently published by the Department of Trade and
Industry, and a report from the Fix the Patent Laws campaign to be released
that day outlining access challenges on a range of medicines in the
country. We invite all concerned people to join us.

The struggle continues.


For media comment contact:

Lotti Rutter | TAC | lotti.rutter at tac.org.za | +27 81 818 8493
Umunyana Rugege | SECTION27 | rugege at section27.org.za | 083 458 5677


Johannesburg Declaration: http://tac.org.za/sites/default/files/
Johannesburg%20Declaration%20.pdf

Video of picket at the Johannesburg UN High-Level panel hearings:
https://www.youtube.com/watch?v=Lo1vNNxU_zQ

Submissions:

TAC made the following three submissions to the High Level Panel:

1.     A call on all developing countries to fully utilise all the
safeguards available in the TRIPS agreement as clarified in the Doha
Declaration to ensure public health is protected http://www.
unsgaccessmeds.org/inbox/2016/2/28/lotti-rutter (Submission endorsed by
AIDS Access Foundation, Thai Network of People Living with HIV/AIDS, FTA
Watch, Delhi Network of Positive People (DNP+), ITPC-South Asia and
 SECTION27)

2.      A proposal for linking intellectual property rights on
pharmaceutical products to research mandates http://www.
unsgaccessmeds.org/inbox/2016/2/27/marcus-low (Submission endorsed by
Knowledge Ecology International and SECTION27)

3.     A call on the HLP to acknowledge the impact of trade pressure
(through mechanisms like the United States 301 Watch List) on the use of
TRIPS flexibilities and for the United Nations to do more to support
developing countries in utilising TRIPS flexibilities https://
highlevelpaneldevelopment.squarespace.com/inbox/2016/2/29/lotti-rutter


We also endorsed the following five submissions:

4.     Amy Kapczyynski of the Yale Global Health Partnership on the right
to health and access to medicines http://www.unsgaccessmeds.org/inbox/2016/
2/28/amy-kapczynski

5.     James Love of Knowledge Ecology International on United Nations
support for Global R&D agreements http://www.unsgaccessmeds.org/inbox/2016/
2/29/james-love

6.     James Love of Knowledge Ecology International on measures that can
be taken to increase the transparency of markets for medical products
https://highlevelpaneldevelopment.squarespace.com/inbox/2016/2/
29/james-lovec

7.     Professor Brook Baker of Health Global access project on radical
reform of global and national intellectual property norms on medical
technologies for all health needshttp://www.unsgaccessmeds.org/inbox/2016/
2/26/z73kpodxk4jw96mhqe2tivq0sd1g3v

8.     Professor Brook Baker of Health Global access project on a
compulsory licensing facility/consortium http://
www.unsgaccessmeds.org/inbox/2016/2/27/brook-baker
--
*Lotti Rutter*
Advocacy & Campaigns Manager

Treatment Action Campaign
Tel: 021 422 1700
Cell: 081 818 8493
Skype: lotti.rutter
Twitter: @TAC @FixPatentLaw @lottirutter

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



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