[Ip-health] SCP26: Statement of Knowledge Ecology International on Patents and Health (July 4th, 2017)

Thiru Balasubramaniam thiru at keionline.org
Tue Jul 4 08:46:44 PDT 2017


Submitted by thiru <https://www.keionline.org/user/6> on 4. July 2017 -

On July 4th, 2017, Andrew Goldman delivered Knowledge Ecology
International's intervention on patents at health at the 26th session of
the WIPO Standing Committee on the Law of Patents (SCP).

*KEI Statement on Patents and Health*
*WIPO Standing Committee on the Law of Patents - 26th Session*

July 4th, 2017

Since the African Group and Development Agenda Group first tabled their
proposal on a work program on patents and health in May 2011, much has

In the words of the delegation of Portugal at this year’s World Health

All regions of the world face, at different levels, insufficient access to
medical products. In recent times, the dramatic increase of prices of new
and innovative medicines made them unaffordable to large segments of the
population also in rich countries, while threatening the sustainability of
health care systems. In too many countries, prices of new medicines (to
treat Hepatitis C and cancer, for instance) are particularly shocking.

The sustainability of health systems is a constant concern and objective.
However, it has been threatened by the exorbitant prices of some innovative
medicines that make them inaccessible to large segments of the population.

The United States is among the many countries struggling to address high
drug prices. On June 27, 2017, Dr. Scott Gottlieb, the head of the US FDA,
said, “No patient should be priced out of the medicines they need, we must
do our part to help patients get access to the treatments they require.” (

What needs to be done?

*Feasibility study on delinkage*

As noted by former UN Secretary Ban Ki-moon in appointing a High-Level
Panel on Access to Medicines, the challenge to making drugs more affordable
and access more equal and fair, is the “policy incoherence” between
intellectual property rights, innovation, and affordable access to
medicines. This includes but is not limited to policies that relate to

At present, the primary global policy to induce investments in biomedical
R&D is to grant a temporary monopoly on a medical invention, enabling the
holder of a patent to charge high prices that undermine affordability and
access. It is hardly surprising that one observes high prices and unequal
access to medicines when high prices are the primary instrument to finance

A growing number of governments, policy experts and stakeholders are
recognizing the need to change the current system, so that the financing of
R&D, including the incentives to private investors, are progressively
delinked from the prices of products.

To accomplish this delinking, governments and international norm setting
organizations have to enhance and expand the rule of mechanisms to fund R&D
that do not rely upon high drug prices, and ensure that laws on patents and
other intellectual property rights are consistent with such reforms.

In 2017, in the United States, 16 US Senators and 14 Members of the US
House of Representatives have called upon the National Academies of
Sciences, Engineering, and Medicine to conduct a study to examine the use
of innovation inducement prize funds and push financing mechanisms as ways
to stimulate investments in biomedical research and development that
de-links costs from product prices.” (http://delinkage.org/

In May 2017, the World Health Assembly (WHA) approved a resolution on
cancer that gives the World Health Organization (WHO) a sufficient mandate
to undertake a feasibility study of delinkage as it relates to the
development of new drugs for cancer. (https://cancerunion.org/2017/

In 2014, WIPO published a study on alternatives to the patent system to
support R&D efforts, in CDIP/14/INF/12. We suggest this study be presented
at SCP27 under the agenda item on Patents and Health.

KEI is working with several other groups and governments to host technical
meetings on the terms of reference for feasibility studies on delinkage,
particularly as this relates to new drugs for antibiotics, cancer, HIV and
rare diseases. We welcome engagement in this work.

*Create pool for shared rights in publicly funded R&D*

KEI proposes that WIPO create an instrument that would create reciprocal
rights in government funded inventions, so that the countries that were
members of such an agreement would agreed to the terms and modalities under
which they could share access to government funded inventions.

*The Canadian proposal*

We take note of the Canadian proposal to conduct a review of existing
research on patents and access to medical products and health technologies.
The study should provide information about all of the cases where
non-voluntary use has been allowed as a limitation on remedies, including,
for example, recent limitations on remedies for infringement of patents on
medical diagnostic tests and medical devices in the United States, the use
of competition law in Italy, compulsory licensing of medical patents in
Germany, and the use and impact of compulsory licensing of patents on drugs
for HIV, cancer and heart disease in developing countries.

*The Canadian proposal and Transparency*

We also suggest the Canadian proposal be expanded to address issues
relating to transparency as it relates to patent landscapes on biomedical
inventions, including biologic drugs and vaccines, the litigation over
patented validity and scope, the growing state practice of limiting the
grant of injunctions when infringement occurs, and the economic aspects of
drug development and commercialization, including the costs of R&D and the
prices and revenues of products, as well as the utilization and gaps in
access for new drugs.

*Flexibilities in Part 3 of the TRIPS*

We urge the SCP to schedule a presentation by experts on the legal basis
and experience of states in permitting the non-voluntary use of patents on
medical inventions as a limitation on the remedies available in Part 3 of
the TRIPS, including specifically cases of running royalties for
infringement of medical devices and diagnostic tests, and the export of
those products outside of the WTO 31bis framework.

Thiru Balasubramaniam
Geneva Representative
Knowledge Ecology International
41 22 791 6727
thiru at keionline.org

More information about the Ip-health mailing list