High-level UN initiative on global public health gap holds landmark hearing

The UN Secretary General’s High-Level Panel on Access to Medicines held its first of two “Global Dialogues” on 9-10 March in London. The High-Level Panel has been tasked by the UN Secretary-General to review and assess proposals and recommend solutions to address the “policy incoherence between the justifiable rights of inventors, international human rights law, trade rules and public health in the context of health technologies.”

The full archive of the 10 March public dialogue is available on the HLP website here. The 9 March meeting was closed to the public, and involved consultations with a shorter list of experts. The agenda for the two days is available here.

Dire Need for Solutions

The UN-led initiative has an air of urgency, with a deadline of June to come up with new ideas for an issue that has been debated for years without full-bodied success.

Industry-oriented speakers led off the day’s contributions and downplayed the need for major change, highlighting progress in this area and the importance of the intellectual property system to innovation.

Representatives from the World Intellectual Property Organization, Novartis, Eli Lilly, the US Chamber of Commerce, BIO Ventures for Global Health, a European pharmaceutical group, and the International Federation of Pharmaceutical Manufacturers and Associations (IFPMA) consistently tried to highlight areas of progress around the world in developing critical medical products and helping them to get to people in need. It was noted that often, infrastructure and health systems are what need attention and not the IP system.

But for the remainder of the event, industry – especially research-based manufacturers – were put on the defensive as speaker after speaker took the view that real change is not occurring and something more substantive needs to be done about the existing R&D model. A key message seemed to be that governments, and the public, should wrest control of the public health system back from industry.

The moderator for the meeting was Financial Times health reporter Andrew Jack. He worked to keep the meeting from falling into polemics and old ruts, focused instead on getting speakers to spell out forward-looking ideas, and “things that can really have traction.”

Some of the high-level panellists appeared to be in the room listening, as were many of the expert committee of the panel. Taking place in London, it was not surprising that many of the participants in the room were from the United Kingdom. The only other public dialogue such as this one will also be from the English-speaking perspective, in South Africa next week.

Former Swiss President Ruth Dreifuss opened with a few remarks. She is co-chair of the 16-member panel, along with former Botswana President Festus Gontebanye Mogae.

She said the High-Level Panel (HLP) had been convened “at a very important moment,” following UN member states’ committing themselves last autumn to “an ambitious development agenda.” One of the most important objectives, Sustainable Development Goal number 3, is related to the right to health, she noted.

Dreifuss said the panel has a “special mission” as it is the first time that a commission is given a “global problem,” affecting every nation, not just part of the world such as least-developed countries. And it is the first time to address not just medicines but all other products such as diagnostics, she added. Furthermore, it is the first time addressing all kinds of diseases, not just limited to tropical diseases or neglected diseases (predominantly affecting poor populations and lacking R&D due to the lack of market incentives).

The panel launched a call for contributions and was “just amazed at the rich harvest of this,” with some 177 contributions received, she said.

“The dialogues are a unique opportunity for government, industry, civil society, and academia to come together to discuss potential solutions for promoting innovation and increasing access to medicines, vaccines and diagnostics, so that we can improve the health and well-being of all people, in all countries,” said Dreifuss.

Civil Society Demands, Envisions Change

Contributions by a number of stakeholders on ways to achieve the goal set to the initiative were discussed. Solutions discussed included delinkage of the cost of research and development from pricing, as well as automatic compulsory licences for essential medicines (allowing affordable generic versions to be made sooner). Another repeated idea was to have a treaty on R&D, maybe at WIPO, maybe at the WTO, for systematic funding of R&D. Also mentioned was to have a patent pool for the WHO Essential Medicines List medicines so as not to be working on it in an ad hoc way, as one participant put it.

The current patent system and its monopolies was described as a strong barrier to access to medicines by a number of civil society members. The patent system was also pictured as gearing research to patentable medicines, to the detriment of needed innovation that would have less market value.

Health advocates from around the world gathered outside the event in a demonstration with a large banner “calling for an end to patent-based monopolies on medicines to tackle rapidly escalating medicine prices,” according to a press release from STOPAIDS.

“The High Level Panel was created by Ban Ki Moon to develop proposals to address the growing problem of medicine prices accelerating to the point where they are unaffordable not only in the developing world but in the UK and Europe. Meanwhile diseases that kill millions every year, such tuberculosis, are ignored because they predominantly affect poor people and so will not generate in profits for big pharma,” the release said.

Saoirse Fitzpatrick from STOPAIDS, standing in front of a banner reading ‘Health is the real wealth’, said, “We’re here to encourage the High Level Panel to show ambition in their work – set a long term vision for a pharmaceutical R&D system which is driven by public health and not by profit, one which doesn’t lead to high prices and rationing of health. There are alternatives that can deliver both innovation and affordability. It’s time to start taking the steps to implement them.”

Legendary US health activist James Love of Knowledge Ecology International said during the dialogue that people in the UK and US are finding it too expensive to get necessary cancer drugs. He broke off in tears as he discussed the situation of his own family.

Numerous suggestions were made throughout the day, and many speakers were convinced that more substantive change is needed to the current system for developing and distributing medical products so that anyone in need can get them. A number of speakers projected that the radical change to the system could come incrementally over time.

Themes were introduced by pre-selected experts, asked to give a “neutral, balanced overview.” Themes included the patent system, delinking the cost of research and development from the cost of production and distribution, health systems, and human rights.

Tom Bombelles of WIPO introduced the patent system and said the IP system is good for innovation. He described how much progress has been made in the world under the patent system, but that the progress has been “uneven”, with some neglected tropical diseases being overlooked. He called for balance, noting the difference between “the cost of innovation and the cost of imitation.”

Prof. Fred Abbott of the Florida State University College of Law and a member of the High-Level Panel Expert Advisory Group, was asked to speak on delinkage. He said many contributions referred to delinking, with the aim of making drugs available at marginal cost pricing.

The justification for high prices, he said, is the need to accumulate capital to be invested in research and development (R&D), and is the foundation of the way industry is currently working. However, this approach brings secondary distortions, such as the fact that it skewed R&D to drugs that can be high priced and also generates a tendency to over prescribe newer drugs, with unknown longer-term side effects, he said.

The assumption that delinkage will result in people not making money is false, said Abbott. R&D can be financed through subsidies and grants, with prizes and orphan tax incentives, he said.

“How much money people can make depends on how much we want to pay them,” he said. “There are ways which make financial sense and everybody comes out well.”

Industry Donations as Solution Raises Indignation

A speaker evoked compassionate programmes that some pharmaceutical companies have set up to provide free medicines to poor populations. Some participants said it was not a matter of social corporate responsibility. Another one said donations often come with strings attached, even from philanthropic organisations such as the Bill and Melinda Gates Foundation.

Several participants from civil society and academics said donations could not be presented as a solution, while a participant from the pharmaceutical sector said in certain cases philanthropy and donation can be used to fill the gap.

Several participants denounced the lack of access to medicines in developing countries but also in developed countries, with for example in the United Kingdom a breast cancer treatment from Roche not available through the National Health System because of its high price.

A generic drug industry executive charged that the well-intentioned US government donation of billions of dollars through its PEPFAR program led to “millions of Africans” dying because the large sum of money was limited to US government approved drugs, which left some key WHO-approved drugs off the list so people could not get them.

A representative of the Universities Allied for Essential Medicines said young people “are sick and tired of fake fixes,” and want delinkage and end products which add therapeutic value. He asked that the panel issues ambitious and visionary recommendations.

Suerie Moon, co-director of the Project on Innovation and Access to Technologies for Sustainable Development at the Harvard Kennedy School of Government, and also member of the HLP Expert Advisory Group, said over the last 15 years, policy experimentation to try to solve the issue of access to medicines has led to a fragmented landscape and there is no systematic way to ensure universal access to medicines.

Moon introduced the segment on health systems. She noted later that is not possible to have good health systems without access to medicines. “We’re missing many of the other elements of the system that would balance out the potential abuses of the IP system,” she said.

Rachel Kiddell-Monroe of UAEM also said there is “an incredibly fragmented” set of alternative initiatives, and said focus could be on those that are “really doing something,” such as promoting open access. This may have been a reference to the long-dragging process at the World Health Organization on these issues.

She also called for mandatory global access licensing of publicly funded research.

A representative from STOPAIDS called for moratorium on TRIPS-plus provisions in trade agreements, which appeared to draw some traction among participants.

A Chatham House representative said the aim might be to get “health, wealthy people” to subsidise poor, unhealthy people. This might be done with compulsory public financing of medicines.

Compulsory Licences, Competition Law, Coherence

Some participants suggested a system which would allow an automatic compulsory licence for medicines on the World Health Organization’s list of essential medicines. Some suggested to exempt pharmaceutical products from patents altogether.

Brook Baker for Health Gap, of Northeastern University School of Law (US), said there is a need for a system supporting countries to amend their laws in order to be able to issue compulsory licences. A facility could be developed to help countries to coordinate compulsory licences so that they create large markets which could attract generic companies. That would not exclude remuneration for patent holders but countries “need to be put back in the driver’s seat,” he said.

Prof. Duncan Matthews of the Centre for Commercial Law Studies (CCLS) at Queen Mary University of London (QMUL), said competition law is an underutilised policy tool in terms of policy coherence, and referred to the World Trade Organization Agreement on Trade-Related Aspects of Intellectual Property Rights (TRIPS). A number of countries have competition laws in place but in practice they are not used effectively, he said.

As summarised in a press release today, Matthews said that competition law – when applied coherently and effectively – can prevent abuse of intellectual property rights in the pharmaceutical industry, which has been criticised for using IP law to restrict competition in areas like generic medicines.

“In some instances, even when competition authorities are active, many anti-competitive practices lack adequate attention,” he said. “This is particularly striking in the pharmaceutical sector. Reverse payment agreements, for example, receive a great deal of attention from regulators. This is where patent holders agree to make a payment to potential competitors so that they will delay entering the market. Other business practices of pharmaceutical companies delay generic entry but competition authorities do not deal with this behaviour at all.”

He added: “Anti-competitive practices create particular challenges for the developing world, given that they allow pharmaceutical patent owners to extend patent monopolies and, when considered together with provisions on data and market exclusivity, can lead to significant barriers to innovation and access.”

Els Torreele of the Open Society Foundation said there is enough money in the system to finance R&D. But the IP system has created a “hugely wasteful” process, she said, designed to reward innovation but not improvement, limiting innovation to only patentable products, irrespective of health outcomes. Proof of therapeutic advances should be provided, she said, adding that more than 70 percent of new patented medicines “have zero added value” for health.

Independent evaluation of new products is needed, said Torreele, and clinical trials should not be left in the hands “of one vested party” with huge financial interests. There is a need to create a publicly financed scientific community to assess new treatments, she added.

IFPMA Director General Eduardo Pisani, for his part, noted that the vast majority of medicines are not patented at all, and said that the real problem is infrastructure in countries.

IP Rights Not Human Rights, Accountability Needed

Richard Elliott, Executive Director of the Canadian HIV/AIDS Legal Network, underlined the fact that IP rights are not human rights. There is a broad over-reach which assumes that IP rights are protected under the Universal Declaration of Human Rights, but “it is simply not true,” he said. There is a proposition on international law according to which in the event of conflict between a human right obligation and obligation under some other treaty such as TRIPS or a free-trade agreement, human rights obligations under the UN charter must prevail, he said.

Paul Hunt, former UN special rapporteur on the right to health, said a number of stakeholders do not keep their commitments. There is a large accountability gap, he said, and there is no proper independent accountability mechanism. He suggested the High-Level Panel includes in their recommendations the need for an independent accountability mechanism with key principles.

Boston University law Prof. Kevin Outterson was among those who called for greater transparency, asking why it is not possible to know where patents are held in the world.

A Medicines Patent Pool representative mentioned the efforts that group has undertaken to develop a drug patent database after finding it hard to determine the simple question of “is this drug protected in country A.”

A UAEM representative mentioned that group’s work on a global access licensing database.

A participant from Brazil said the TRIPS flexibilities provides for the right to escape retaliation, but there is nothing in the agreement that prevents other kinds of pressure.

Written Contributions Pouring In

The High-Level Panel had launched a call for contributions from all interested stakeholders in December and has received nearly 180 contributions so far. On 9 March, a closed session was set up as a hearing to review and discuss key contributions, and hear from experts.

Contributions were submitted by governments, non-governmental organisations, industry and academics, some submitting several contributions.

Among the governments submitting contributions were the United States Department of State, the Ministry of Foreign Affairs, and the HIV/AIDS Committee of the Mozambique Parliament.

A number of academics have submitted contributions such as Boston University, University of Ottawa, Madrid University, Open University, and Yale University. Also contributing are non-governmental organisations, such as the Third World Network, Knowledge Ecology International, and Médecins Sans Frontières (MSF, Doctors Without Borders). Others, such as the Open Society Foundations, also have contributed.

A number of industry representatives have also tabled contributions, such as GlaxoSmithKline, Gilead Sciences, the International Generic and Biosimilar Medicines Association, and Merck Germany.

Whether the High-Level Panel will be successful in bringing about real change remains to be seen.

UAEM’s Kiddell-Monroe in the hearing captured the optimism of many, saying, “This could be a very historic moment,” and that in the future, they could look back on this panel initiative and say, “this is the moment where we really brought change.”

Source: Intellectual Property Watch