[Ip-health] IP-Watch: Unlikely Alliance Of India, US Could Keep Medicines Access On WHO Agenda

Thiru Balasubramaniam thiru at keionline.org
Sun May 28 10:16:38 PDT 2017


Unlikely Alliance Of India, US Could Keep Medicines Access On WHO Agenda


It is not often that on the matter of access to medicines, India and the
United States agree at the World Health Organization. But the issue of
access to medicines is rising on the international agenda and developed
countries are feeling the bite of prices of new medicines. Core
beneficiaries of the patent system held steady this week, but among their
defenders, the issue is blurring as some countries, such as the
Netherlands, Greece and Portugal, are not putting up with industry prices
and are saying it.

Access to medicines was addressed in conjunction with the global shortages
of medicines this week at the 70th World Health Assembly (WHA), taking
place from 22-31 May.

A committee at the WHA on 27 May adopted a proposal by India, supported by
the United States, that the discussion on access to medicines be an agenda
item at the WHO Executive Board in January 2018. A bolder proposal by South
Africa that the issue become a standing agenda item at the WHA, which was
supported by a number of countries, was discarded by the secretariat
somewhat abruptly at the end of the discussion today.

The WHO members noted the report [pdf] of the secretariat on the shortages
of, and access to medicines and vaccines.

The issue of access to medicines is highly contentious, and most recently
at its centre lies the recent report of the United Nations Secretary
General’s High-Level Panel on Access to Medicines, and its recommendations,
which was forcefully criticised by some countries, such as the United
States, Japan, and the pharmaceutical industry, as providing a narrow
vision of the issue, and making IP the scapegoat. But discussion of the
report’s recommendations was supported by a greater number of countries,
and the issue will likely remain on the list under the shortages and access
to medicines item.

The head of the South Africa delegation, Precious Matsoso, also a member of
the High-Level Panel, said yesterday that United Nations agencies need to
work together to achieve coherence. Some of the recommendations of the
High-Level Panel are “delicate,” she said, as has been recognised by the
panel. The delegate suggested that the topic of the High-Level Panel
recommendations might become a standing agenda item in the WHA. This would
promote further discussions and dialogue, and give the newly elected
director general taking over in July a chance to familiarise himself with
the High-Level Panel report.

But the outgoing director general, Margaret Chan, told the committee that
she had an informal conversation with proponents of a standing agenda item
and it was agreed they would support the issue being placed on the agenda
of the Executive Board under the broader topic of shortages and access to
medicines. South Africa then took the floor and indicated that this was not
quite their understanding, but this seeming objection was washed over as
the secretariat proceeded to close the item hearing no objections. A WHO
expert told Intellectual Property Watch afterward that the agenda item is a
“to-do” list and anything can be brought up under it, and also said that
legally any action proposed under a standing agenda item could be proposed
under the Executive Board agenda item.

A large number of countries took the floor yesterday and this morning to
support the inclusion of the discussion on access to medicines on the 142nd
WHO Executive Board (EB) meeting agenda (January 2018), such as Colombia,
Bangladesh for the South East Asia region, Brazil, Venezuela, Congo,
Portugal, Germany, Bolivia, Ecuador, Japan, Malaysia, Tanzania, UK,
Tunisia, Botswana, Morocco, and Nigeria.

Brazil and Ecuador, supporters of the inclusion of the item at the next EB,
also supported the standing agenda item at the WHO. Ethiopia, Ghana,
Russia, Bolivia, and apparently Canada, supported the inclusion of the item
in the WHA.

Several countries requested that discussions be carried out on the issue,
with member states before the January EB meeting, such as Japan, the US,
and Brazil.

Countries said shortages are not only depriving patients from getting the
medicines but had the double effect of raising prices. Some also said that
shortages are due to a number of factors, such as market fragmentation, and
the limited number of local manufacturers.

Many also underlined the necessity for safe, effective, and affordable
medicines and vaccines.

Algeria said access to medicines and vaccines, in particular in low and
middle-income countries, is crucial not only to improve national plans, but
also to achieve the UN Sustainable Development Goals (SDGs) by 2030.

Some countries linked the issue of the high cost of medicines to the
presence of falsified medical products on the market.

European Countries React to High Prices, Get Organised

The Netherlands underlined the result of the 10-11 May Fair Pricing Forum,
which was hosted by the country, and said the forum expressed a clear need
for transparency, and reservations about value-based prices for medicines.
Value-based pricing links the price of medicines to their societal value.

Governments need to take a stronger role and collaborate, share information
on prices and join in collective negotiations. The Netherlands, the
delegate said, joined forces with other countries in a negotiation with the
pharmaceutical industry recently. Unfortunately, no agreement came out of
that negotiation, but the fact that the countries rejected an offer from
the pharmaceutical industry shows that governments should take position on
what they think is a fair price, he said.

The Netherlands delegate encouraged governments to look at “promising new
models” and market-shaping initiatives.

He urged WHO member states to improve their legislative environment, and
preserve the flexibilities included in the World Trade Organization
Agreement on Trade-Related Aspects of Intellectual Property Rights (TRIPS)
in favour of public health.

Greece mentioned the continuous rise in the need for long-term treatments,
particularly bio-medicines, for noncommunicable diseases. The delegate also
underlined the shortages of medicines, and said many pharmaceutical
companies are withdrawing their products from the market due to their low
selling price. The issue of access to medicines and vaccines touches every
country and it should be acknowledged as a global problem, the delegate

Portugal said all regions at different levels face insufficient access to
medicines, and increasing prices – including in rich countries –
threatening health systems. Governments should work with the pharmaceutical
industry, he said, and get value for money and affordable medicines.

The Portuguese Ministry of Health welcomed the contribution of the
High-Level Panel on Access to Medicines, and said greater transparency is
needed to determine the cost of R&D of medicines and how it is reflected in
end prices, the delegate said.

Earlier this month, he said, five other countries along with Portugal
signed a declaration to cooperate in full solidarity and transparency for
better access to medicines.

Austria called for strict patentability criteria to deliver a monopoly only
for innovative medicines.

Canada said the country is paying the third highest prices of medicines in
the world, and the country is conducting a consultation on patent and
medicines to protect consumers.

Protect Innovation System, IP, Say Some

Some countries, such as Norway, and Germany said the patent-based system
has delivered a number of innovation. Norway however said it does not
address all public health needs, and in case of market failures, other
mechanisms, such as Product Development Partnerships should be used to
carry out R&D.

Japan strongly defended the IP system, and said there are doubts whether
weakening the system would bring a solution to the issue of access to
medicines. Giving incentives to new medicines and vaccines producers
promotes R&D activities, he said, and benefits people around the world.

Switzerland, the United Kingdom, and Australia remarked on the complexity
of the access to medicines challenge, Australia calling for a “holistic
approach” to the issue, not singling out IP. The UK called for promoting IP
in favour of public health.

The US also commented on the increasing cost of new medicines, and the need
to address the multiple factors at play, with the concern of preserving
innovation. The US delegate said his country cannot agree with the
High-Level Panel, which had a “flawed mandate” and whose recommendations
could have unintended negative consequences.

Capacity Building for Local Manufacturing

Ethiopia for the African region asks that WHO provides capacity building in
the region, helping to build the capacity of local pharmaceutical
manufacturers, in particular for vaccines. Unless the region builds its
capacity, the delegate said, the aspiration of many African nations to
become middle-income countries and beyond will be unlikely.

India commented on its role of generic medicines provider, and said some 55
percent of the country’s production is exported. He remarked that India
meets the stringent quality requirement of importing country regulations,
which are “becoming more stringent with each passing year.” Shortages of
medicines would be mostly addressed through the use of TRIPS flexibilities,
he said, and by sharing the fruits of publicly funded R&D.

WHO Agrees on Complexity, Against Value-Based Pricing

Marie-Paule Kieny, WHO assistant director-general for Health Systems and
Innovation, agreed on the complexity and the importance of the topics, and
said she appreciate the ongoing interest demonstrated in governing body

She said the WHO support the EU and the Netherland on the fair pricing
forum, and on the need for increased transparency in pricing, cost of R&D,
and production.

She also mentioned the concept of delinking the price of products and the
cost of R&D but said both prices and costs should actually be known. She
voiced concerns about a new principle of value-based pricing linking prices
to societal value, saying it is not acceptable to patients to put prices at
the value of a life (IPW, WHO, 26 May 2017).

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