[Ip-health] IP-Watch: Ingredients For WHO Roadmap On Access To Medicines At Civil Society Side Event

Thiru Balasubramaniam thiru at keionline.org
Fri May 25 20:27:52 PDT 2018


Ingredients For WHO Roadmap On Access To Medicines At Civil Society Side


On the side of this week’s World Health Assembly and hours before the
Assembly agreed on preparing a roadmap on access to medicines, two civil
society groups held an event on the same subject. The Brazilian ambassador,
a senior official from the Netherlands, and a WHO assistant director
general among others delivered their thoughts on the issue and the way
forward. Key words were high prices, transparency, and trade flexibilities.

KEI’s James Love and HAI’s Tim Reed at the WHA yesterday

Knowledge Ecology International and Stichting Health Action International
(HAI) held a panel discussion on WHO’s Roadmap on Access to Medicines and
Vaccines on 23 May.

HAI published a policy brief on the way forward for access to medicines on
21 May.

Brazilian Ambassador Maria Nazareth Farani Azevêdo said access to medicines
“invites my passion” on several fronts, in particular on the health, human
rights, political, commercial and economic fronts.

Access is essential to universal health systems, she said, adding, “if you
are a politician, you have to deliver on health. You won’t survive if you
don’t deliver on health.”

Access to medicines is vital to every single aspect of the health agenda,
she said, and the establishment of strong and resilient health systems
depend on proper access to medicines, diagnostics, and vaccines. However,
the topic of access to medicines remains the most pressing and the most
controversial health scenario in multilateral fora.

She insisted on the importance of the balance between the legitimate right
for industry to innovation and research and development (R&D) and the right
to life of people.

“We have to join forces and open our hearts and mind,” she said, and find
some common ground. The solution does not have to come against anybody’s
interest, she added. The common ground can be found in the WHO roadmap on
access to medicines, she said, underlining the role of civil society as a
bridge builder between governments and the private sector.

EU Attentive to Issue, Preparing Report

Herbert Barnard, director of international affairs at the Dutch Ministry of
Health Welfare and Sport, said the Netherlands is a strong supporter of
access to medicines for patients. This was reflected in the 2016 Council of
the European Union conclusion on strengthening the balance in the
pharmaceutical systems in the EU and its member states, he said.

The conclusion identified the issue of access to affordable and innovative
medical products within the EU, and potential actions to be taken, he said.

Such actions include closer cooperation between regulatory bodies, he
explained, adding that the EU members were invited to prepare an
evidence-based analysis of current EU instruments to facilitate innovation.
According to the conclusion, the evidence-based analysis should also look
at the availability, supply shortages, and deferred or missed market
launches, and accessibility of medical products, “including high priced
essential medicinal products for conditions that pose a high burden for
patients and health systems.”

According to Barnard, the EU report is expected “anytime soon.”

On the WHO roadmap, he said it should be balanced at all stages of the
value chain, the challenges should be addressed in an holistic manner, with
attention to fair pricing, quality, and the appropriate use of intellectual
property in stimulating innovation.

There is a need to seriously address the high prices of medicines, he said,
and ensure affordability and availability of medicines now and for the
future, adding that the issue goes beyond high prices. He said transparency
on data such as R&D costs, clinical trial data, procurement prices and
supply chain mark ups are important.

WHO: IP Discussion Not Closed

Mariângela Batista Galvão Simão, assistant director general, Drug Access,
Vaccines and Pharmaceuticals at the WHO, remarked on the debate at the WHA
on access to medicines (IPW, WHO, 24 May 2018) and said several member
states framed access to medicines and vaccines in the human right
framework, including the EU.

At the end of the day, she said, public health professionals and activists
need to make sure that policies for which they advocate are easy to
implement. There are areas where no consensus is met, such as the delinkage
between the cost of R&D and end prices, and the funding of R&D. The
discussion on intellectual property is not closed, she said.

Procedures Should not be Patentable

James Love, director of Knowledge Ecology International (KEI), talked about
the Chimeric Antigen Receptor (CAR) T-cell therapy which was approved in
the United States for blood cancer. The basic technology, he said, is to
drain the patient’s blood and isolate his/her T-cells to modify them with a
publicly sequenced virus, then three weeks later reinject those T-cells.
T-cells are white blood cells with key importance to the immune system.

The question is, is this therapy a product or is it a procedure, he asked.
In KEI’s opinion, it is a procedure which is of prime importance as it is
curing the patient and will soon be applicable to other cancerous tumours.
A procedure should not be patentable, he said, and should be rejected by
patent offices.

Love also commented on the concept of delinkage of R&D cost from end prices
and said if the incentive for innovation is giving the inventor a monopoly,
it should come as no surprise that prices are very high. Delinkage is the
only way to have a permanent solution to high prices, he said, and the
price of drugs cannot be an incentive for innovation. A feasibility study
would prove the point but “we are not allowed to thing about an
alternative” model, he said.

TRIPS Flexibilities: ‘Jump and Swim’

Telling people that they should use the flexibilities in the World Trade
Organization Agreement on Trade-Related Aspects of Intellectual Property
Rights (TRIPS) is like saying to someone “you are human so you can swim,”
said Luis Villarroel Villalón, director of Innovarte in Chile.

It is important that the WHO helps countries to understand how to use the
TRIPS flexibilities, he said. There is no guidelines on how to run the
process, which is complicated, he said. There is an urgent need for WHO to
prepare standards for countries to look if they have the capability and
human resources to run through this process, he said, explaining how Chile
granted a compulsory licence for a hepatitis C medicines.

Cancer Drugs High Prices, Industry Flourishing

Ellen ‘t Hoen, director, Medicines Law and Policy, University Medical
Centre, Groningen (Global Health Unit), also underlined the use of TRIPS
flexibilities, and remarked on lessons learned with HIV, which could be
useful to the debate on access to medicines.

Cancer drug prices are in the spot light, she said and there is an
increasing resistance to high prices, in particular from oncologists. The
“elephant in the room,” she said, is that the industry is doing very well,
being one of the most profitable business on the planet.

She cited a Goldman Sachs report to industry which stated that curing
patients is not a sustainable business model. The report cited the case of
Gilead sofosbuvir against hepatitis C, which “made billions” out of the
sale of the drug, but has “exhausted the pool of potential patients,” said
‘t Hoen.

Looking at figures, she said, “there is an immense pool of patients that
are not treated.”

She suggested expanding the coverage of the Medicines Patent Pool to
include all medicines on the WHO Essential Medicines List, and insisted on
the need for greater transparency in the pharmaceutical industry.

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

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