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

BY CATHERINE SAEZ, INTELLECTUAL PROPERTY WATCH

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 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 added.

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 meetings.

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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