PHM-Exch> Access To Affordable Healthcare: A Global Wake-Up Call Fosters Coalition Of The Like-Minded. World Conf on access to med prods

[Claudio Schuftan]

From: South Centre <south at southcentre.int>


*Access To Affordable Healthcare: A Global Wake-Up Call Fosters Coalition
Of The Like-Minded*

*By Patralekha Chatterjee*

Few topics in the global health agenda are as contentious as access to
affordable medicines and medical care, and expectedly, divergent views
permeated the discussions at a high-level conference in New Delhi, India
last week. But if there is one thing that the three-day meet made amply
clear, it was this: access to affordable healthcare has emerged as a global
problem, and an emerging coalition of the like-minded, cutting across the
developed and developing countries, is determined to have their voices
heard in international policy circles on the issue.

The 1st World Conference on Access to Medical Products and International
Laws for Trade and Health in the context of the 2030 Agenda for Sustainable
Development was held in New Delhi from 21-23 November.

Organised by India’s Ministry of Health & Family Welfare with the support
of the World Health Organization (WHO) Country Office for India in
partnership with the Indian Society of International Law, the conference
brought together a wide range of stakeholders including many scientists and
key government officials from India, the host country, academics from
around the world, international NGOs like Médecins Sans Frontières and also
patient support groups.

According to a concept note circulated in the run-up to the event, the aim
of the conference was “to provide a forum for stakeholder participation in
access to medicines debate including trade and health policy” and “to
inform policy in the framework of globalization and trade agreements for
access to medical products for achieving SDGs” (the United Nations
Sustainable Development Goals).

Key ideas emanating from the conference are expected to contribute towards
discussions in the WHO Executive Board meeting in January.

Two examples tellingly brought out the concerns surrounding the issue of
‘access’ during the deliberations at the New Delhi meet.

First, that even a country as affluent as Switzerland did not offer
unrestricted reimbursement of new hepatitis C drugs through health
insurance to all patients till very recently. This led to many Swiss Hep C
patients buying generic versions of the drug – manufactured under licence
in countries like India – online or by travelling overseas, as Christoph
Spennemann, legal officer, intellectual property unit, UNCTAD (UN
Conference on Trade and Development), noted during one of his presentations.

Second, an intervention from the floor on the final day of the conference
from Archana Panda, member of a group which calls itself Families of Spinal
Muscular Atrophy India (FSMA India). Panda’s 15 year-old daughter suffers
from Spinal Muscular Atrophy, and she recounted the travails of a
distraught parent who has no choice but to mutely watch the condition of
her child worsen though there is a new medicine for the ailment – Spinraza,
a US Food and Drug Administration (FDA)-approved treatment from the
multinational pharmaceutical company Biogen. The reason: the cost was
prohibitive (USD 750,000 per year per child) and the manufacturer did not
have any immediate plans for making the drug available in India.

Henk Bekedam, WHO representative to India, called it a “timely meeting” as
“India, considered the pharmacy of the world, is now moving from generic
drugs and vaccines to manufacturing medical products and diagnostics and
access to medicines and medical products is key to universal health
coverage.”

The New Delhi conference provided a huge platform to advocates of the UN
High Level Panel on Medicines, and the report’s recommendations found
mention in several sessions during the three days.

It also turned out to be an occasion where India sought to demonstrate that
it is not without allies or support. India has been under serious pressure
from countries that are home to multinational pharma companies, notably the
United States, and remains on the Office of the US Trade Representative’s
‘priority watch’ list in its annual Special 301 report. This report
unilaterally assesses the adequacy of trading partners’ protection of US
intellectual property rights.

“The importance of IPR is acknowledged but that being said, we can’t say
that price control especially for medicines doesn’t matter. If you want to
sell in India, and it is an essential medicine, we have a right to control
prices. Our population can’t afford high prices. Making profits is fine but
making obnoxious profits is a ‘no.’ No country including the US allows it.
Why should we be defensive? We have one of the best patent laws in the
world,” Rajiv Aggarwal, joint secretary, Department of Industrial Policy
and Promotion, India Ministry of Commerce and Industry, told Intellectual
Property Watch. Asked about the attacks on India’s patent regime, Aggarwal
laughed. “That is okay. Don’t worry about that.”

“There is still a difference of opinions between developed countries and
developing countries. Developed countries are trying to kill TRIPS
flexibilities, but we are getting new allies – WHO and UNCTAD are
encouraging – there is increasing support for our policies,” G R
Raghavender, joint secretary, National Mission for Justice Delivery and
Legal Reforms, Ministry of Law and Justice India, told Intellectual
Property Watch. TRIPS refers to the World Trade Organization Agreement on
Trade-Related Aspects of Intellectual Property Rights.

Ruth Dreifuss, co-chair of the UN High Level Panel on Medicines, former
President of the Swiss Federation, and one of the prominent delegates at
the conference, said in an interview, ‘What is important [about the
conference] was that there were representatives from countries that can
really push the WHO to take forward the proposals of the UN High Level
Panel on Access to Medicines and persuade their own expert groups on access
to medicines to take a step forward in practical terms. Countries like
India, Brazil, South Africa can push for discussions that can lead to
practical solutions.”

“Collaboration between countries in the South-East Asian region can be a
key step if they are ready to have a common policy not just on registration
of drugs but also on what is patentable and what is not. The other
important aspect about the conference was its insistence on the fact it is
not just about medicines but also vaccines, diagnostics and medical
devices, Dreifuss added. “There is not enough awareness about the high
prices of diagnostics.”

“It seems the government of India is taking research and development
seriously within the country and is interested in linking with other
countries at the global level. That is good,” Mohga Kamal Yanni, senior
health and HIV policy advisor, Oxfam, Great Britain, and a member of the
Expert Advisory Group advising the UN High Level Panel on Medicines, told
Intellectual Property Watch.

“Even talking about transparency, low prices, R&D – all the issues raised
by the UN High-Level Panel – and taking it forward, despite the huge
pressure from countries like the United States and big pharmaceutical
companies, is something!” she said. “India has started doing it; it needs
to really invest in doing it and should really lead the discourse, with
like-minded governments. Now, there are governments in Europe who say they
have problems with pricing and look for other models of innovation and they
all need to link with other developing countries like Brazil and South
Africa and Egypt.”

During his inaugural speech, India’s Health Minister J P Nadda made it
clear that India intended to align its public health goals with the
government’s flagship programme ‘Make in India.’

“In India, nearly 150,000 orthopaedic knee procedures are done every day.
More investments and more players in the medical devices sector will lead
to lowering down of prices and access to medical products as most of the
governments are sensitive to access and pricing of medical products,” Nadda
said.

One issue which featured prominently in discussions about intellectual
property rights, trade, and access to medical products was the use of TRIPS
flexibilities, the shorthand for public interest safeguards in the TRIPS
agreement.

UN Sustainable Development Goal (SDG) 3, which speaks of the need to
‘ensure healthy lives and promote well-being for all at all ages’, has
specific references to the 2001 Doha Declaration on the TRIPS Agreement and
Public Health, which affirms the right of developing countries to use to
the full the provisions in the TRIPS agreement regarding flexibilities to
protect public health, and, in particular, provide access to medicines for
all, Anand Grover, senior advocate and former UN Special Rapporteur on the
Right to Health, reminded the audience on the first day.

But the ensuing discussions made it clear that many countries were under
pressure not to use TRIPS flexibilities.

One issue which generated a lot of animated debate was ‘delinkage,’ a term
that refers to a business model for drug development and the incentive to
invest in R&D that is delinked from drug prices.

The position paper (not yet online) circulated among delegates on the eve
of the conference, talks at length about the ‘Role of Innovation, Research
and Development for Medical Products’. It notes that the current model of
innovation in medical technologies is facing considerable challenges and
that the ‘lack of transparency in providing real costs of medical research
thereby leading to high costs of medical products creates access issues for
the public at large.” The paper also notes that IPR is useful as an
incentive but “it is debatable whether the IP system can incentivize
inventions in areas where there is no market.”

Participants at the conference stressed the urgent need for a global
agreement on research and development of medicines and medical products.
There were several allusions to the need to foster local production,
technology transfer and market entry barriers for medical products. There
were charged discussions on voluntary licensing versus compulsory licensing
with health activists rooting for the latter as a necessary tool to further
the cause of affordable medicines.

How much of the talk will translate into action? One glaring gap at the
conference was insufficient money talk on key issues.

“I am happy that the report of the UN High-Level Panel on Access to
Medicines got huge play in the New Delhi conference. This will be a major
contribution towards discussions in the WHO Executive Board meeting in
2018. The ideas were on the table. But what was not on the table was the
money to really allow common R&D for public priorities and public use. I
must also say that in discussions on trade and health, there is still an
imbalance in favour of trade,” said Dreifuss.

Who is going to take the debate about delinkage forward? Many participants
said WHO should take up the issue. “The most pressing thing now is to have
technical people flesh out the practical details of implementation,” James
Love, director, Knowledge Ecology International, an NGO working on
knowledge governance, told Intellectual Property Watch.

Anban Pillay, deputy director general for health regulation and compliance,
South Africa Department of Health, told Intellectual Property Watch that
multinational pharmaceutical companies need to be much more a part of the
conversation. South Africa, he said, had adopted the voluntary licence
model.

“What I would like to build on is delinkage if we agree on delinkage as a
principle,” he said. “But you still have to deal with the industry no
matter what the research costs are. We need to talk about what is a
reasonable margin (of profit), how we can distribute this reasonable margin
among different countries globally.

“Right now, the business model is to sell one’s product in high value
countries, maximise profit and then think of the poor,” said Pillay. “There
could be another approach. The debate on delinkage has been around for a
long time. If  the conversation is not with just oneself, the industry, the
pharma companies, need to be on the table.”

The final outcome document from the conference is awaited. Meanwhile, India
has already offered to host the 2nd World Conference on Access to Medical
Products. What is needed between now and then is greater clarity on
implementation and funding of the various proposals that were discussed at
the Delhi meet.
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