UN High-Level Panel: Ideas For Change To Global Health And IP System Proliferate

Public health advocates, academics, patients, governments and others this week presented further ideas to the United Nations Secretary-General’s High-Level Panel on Access to Medicines on ways to break the longstanding pattern of expensive medical products around the world as a way to pay for research and development.

The second public dialogue of the High-Level Panel took place in Johannesburg, South Africa on 17 March, a day after closed-door meetings with a range of experts who submitted written comments to the panel. A first public dialogue was held in London last week (IPW, Public Health, 11 March 2016).

The full Johannesburg webcast is available here.

High-Level Panel Public Dialogue in Johannesburg this week

High-Level Panel Public Dialogue in Johannesburg this week

The UN High-Level Panel was launched by UN Secretary General Ban Ki-moon in November with the task of finding solutions to the lack of access to medicines and in particular seek to rectify the “policy incoherence between the justifiable rights of inventors, international human rights law, trade rules and public health in the context of health technologies.”

Ruth Dreifuss, former president of the Swiss Confederation and co-chair of the High-Level Panel, at the opening of the 17 March session noted the presence in the room of a large array of positions and experiences. The panel, she said, is open to all ideas and all contributions and will consider all 176 written contributions submitted in February by different stakeholders.

The panel is now in the stage of collecting ideas and contributions, she said, and would not react to the different propositions because the shape of the report which the panel is expected to be submitting to the UN Secretary General in June, has not been agreed upon between the panel members. “We are listening very hard and with great interest,” she said.

The High-Level Panel will meet at the end of March to agree on the shape of the report and which direction it should go, she added. They’ll spend April working and then meet again in May.

The agenda [pdf] for the Johannesburg public session included two main sections, as described by hearing moderator Andrew Jack of the Financial Times.

The first section focused on the existing framework, and included the broader issue of health systems strengthening. The second section opened the way to more substantive proposals beyond the existing framework.

The second part of the hearing dealt with the strengthening policy coherence of patent-related mechanisms; the de-linking of research and development costs from the prices of health technologies and new financing mechanisms; and proposed to reflect on advancing policy coherence.

The public hearing had a video link with Bangkok and speakers from different Asian countries were invited to explain their proposals to help the issues of access to medicines.

A separate story on the interventions from Bangkok is here (IPW, United Nations, 18 March 2016).

This week’s event in Johannesburg included several heart-rending stories from South African cancer and tuberculosis patients who described their ordeals in trying to obtain high-priced or inaccessible treatments they needed, or the side effects they experienced such as deafness.

Below is a series of highlights from the public dialogue in Johannesburg.

Trade, Health & Human Rights

Prof Fred Abbott of the Florida State University College of Law, a member of the High-Level Panel Expert Advisory Group, introduced the topic of trade policy, noting there are four rules systems: health, human rights, trade and intellectual property, and each has mechanisms of action but there is potential for conflict.

He listed a variety of trade and legal disputes, including an issue in 1997 of limiting medicines to patients in event host South Africa that some said launched the access to medicines movement. In addition, Abbott said there are day-to-day issues of R&D and access. The task of the panel is to address these inconsistencies, he said.

Roger Kampf of the World Trade Organization IP Division delivered the message that “health definitely has a voice in the WTO.” And he clarified that “trade does not trump health.”

Kampf highlighted a few ways in which the WTO is involved. For instance, it is the venue for discussions of the Council on TRIPS, reductions in tariffs have led to lower prices for pharmaceuticals, and the recently completed Trade Facilitation Agreement should help with procedures and lower costs.

In addition, he said, the TRIPS agreement is itself a “blueprint” for policy and legal coherence, echoing one of the goals of the panel. Other items he noted were the first-ever amendment to TRIPS, which was on public health, and a trilateral study on health of the WTO, WHO and WIPO.

A number of speakers highlighted the primacy of the human rights aspect of health, and urged that the internationally accepted right to life and right to health must take priority. “This should be the starting point for the panel,” one Kenyan academic put it.

Making Sense of SDGs and the Panel

Suerie Moon in Johannesburg

Suerie Moon speaks in Johannesburg

Suerie Moon, co-director of the Project on Innovation and Access to Technologies for Sustainable Development at the Harvard Kennedy School of Government, and member of the Panel’s Expert Advisory Group, gave some background, noting South Africa was “in many ways the birthplace of the access to medicines movement, which has been quite successful, though the work is not yet done.”

Now is the era of the Sustainable Development Goals (SDGs), she said. The difference with the SDGs over the predecessor Millennium Development Goals (MDGs) is that the SDGs depend on all governments meeting their commitments, she said.

And for governments to protect the rights of their populations, when prices are too high, they are “obliged to do anything possible” to make medicines more accessible, he said.

And for governments to respect the right to health, developed country governments should not be demanding stronger, longer protections in trade agreements.

“We need to rethink the way we are negotiating global rules so we have some chance of achieving SDGs,” Moon said.

On one more point, she noted the day before (in closed meetings), they were reminded that the patent system is a global social contract, and there are “certain obligations that come with the rights that are granted.”

This implies that governments have an obligation to contribute to R&D costs, and they do every time their populations pay high prices for medicines, she said.

“But we’re doing it in a way that’s “not very smart, not very strategic, and a way that is not very equitable,” she added. That’s because high prices mean many people do not have access.

“So what is needed is another way to pay for R&D,” she said. “This is where delinkage is so central.” It implies a need to pay for R&D with public money and demand a fair return on public investment.

“What that means is no monopolies on medicines that are financed with public money,” she said.

Human Rights, Voluntary Licensing, LDCs and Imitation

A commenter from South Africa suggested that what is needed is to strengthen monitoring mechanisms.

K.M. Gopakumar of the Third World Network argued that human rights are pre-emptory, which gives the right to governments to override any other right.

A Brazilian representative said that a government negotiating with a monopoly, with no others in competition, is problematic and leads to higher prices.

It was proposed again as in London that medicines listed on the WHO Essential Medicines List be exempted from TRIPS, noting as one advocate put it, that the ability to use TRIPS flexibilities has “not kept up.”

Pharmaceutical companies might not disagree since they regularly point out that the majority of medicines on the Essential Medicines List are already off patent.

There were also some mixed views on the voluntary licences negotiated by the Medicines Patent Pool (MPP), such as that they are positive but should not be the only option. Gopakumar said it gives a handle to states to abdicate their responsibility.

And a speaker said voluntary licences do not implement the TRIPS flexibilities and “may in some cases undermine them” by giving rights to companies in some regions. The speaker also noted that even with the ability to challenge patents, if the challenge is under appeal, the patent is still considered enforceable.

Economic adviser to Malawi President

Malawi Economic Adviser Collins Magalasi

The chief economic adviser to the President of Malawi, Collins Magalasi, called for least-developed countries (LDCs) to be given an indefinite period of waiver of applying the TRIPS agreement, for as long as they are LDCs, echoing recent debates at the WTO.

He also cited policy inconsistencies in countries, where a country like Malawi is a member of different regional organisations that are not always aligned to their national interests. He called for the drafting of new coherent policies that take into account public health realities on the ground.

He further cited technological capacity problems, asking for technical cooperation and financial support.

Another South African activist also said technological capability is needed. And he raised concern that the panel would not be able to have a real impact because the UN has no enforcement mechanism, compared to the WTO. “Don’t take a knife to a gunfight,” he said. Brazil, for instance, has well used the WTO cross-retaliation mechanism, allowing it to receive damages through penalties on US intellectual property if it wishes.

A representative of the Japan government gave a throwback presentation that countered the recurring calls for dramatic change, calling instead for consideration of existing mechanisms, and maintaining a “good balance” of IP protection and access. He stressed the importance of R&D, acknowledging only that the market mechanism is “sometimes inadequate for certain neglected diseases.” This was in contrast to many other statements over the two dialogues that the issue now reaches beyond diseases only afflicting poor populations.

He also suggested looking at how to supply generic medicines as many are already available as generics, as well as health systems strengthening as an alternative to looking at patents.

This elicited surprise from a Burcu Kilic of Public Citizen in the US who said Japan ironically was a model for development of an IP and innovation system because in the beginning it did not allow patents on pharmaceuticals and practiced imitation until its industry was ready. “Africa first needs to learn how to imitate,” she said. Kilic and others made a distinction between innovation – which is commercialisation – and invention.

A representative of the African Network for Drugs and Diagnostics Innovation, hosted by the UN in Addis Ababa, cited a study on the patent landscape of 20 diseases and technologies in Africa that showed only 0.2 percent were from Africa. He encouraged the panel to promote innovation from the bottom up.

The South African activist said China “has shown us that you can copy.” Do not come and tell developing countries that R&D costs $1 billion, he said.

Gopakumar, meanwhile, said that there is not much policy space left in the IP and access debate, and suggested IP issues be kept separate from the rest.

He also said about TRIPS that if countries face constraints in using flexibilities then the notion that flexibilities are available “falls apart.” Political pressure goes against international obligations, he said, and any group exerting pressure should not be considered a partner.

Health Systems Strengthening

The topic of health systems brought out commenters that lean more toward the status quo and industry perspective. For instance, a representative of the group PATH described the issue as “complex” and multidimensional, as opposed to just about IP. She said the panel should consider how to ensure groups like GAVI and the Global Fund for AIDS, Tuberculosis and Malaria “have enough power” to carry out their missions.

A representative of the United States applauded the panel, a turnaround from doubts cast on the panel at its inception in New York a couple of months ago (IPW, United Nations, 5 February 2016).

He highlighted a few points from the government’s written submission. Issues of access to medicines according to the WHO include rational use and selection, affordable prices, sustainable financing, and health systems, he said. So it is broader than IP, he noted.

Judit Rius

Judit Rius

Judit Rius of Médecins San Frontières (MSF, Doctors Without Borders) called on the panel to oppose trade agreements such as the Trans-Pacific Partnership (TPP) because they will be so negative for medicines access. She also said there is a “complete inconsistency” between what the US government is telling the panel and what is happening on the ground in the US, where lawmakers and others are actively working to lower drug prices that have proved to be too high for US citizens.

And a representative of the advocacy group Section 27 said the debate on these issues has not moved in a decade, and that there is a need to raise awareness of other diseases. What is lacking this time around is the massive engagement of patients, he said, though he acknowledged the participation of several patients in the room.

On health systems, a senior WHO official introduced the topic and said, “You cannot build an access to medicines policy when your system relies on out-of-pocket payments.” So it is important to look at how resources are spent, and it is clear more could be done in procurement and negotiations with industry. Also, it is taking too long from the WHO prequalification of a drug to making drugs available, anywhere from one month to 8 years.

On the WHO Essential Medicines List, he said it originally involved medicines being affordable, until the HIV/AIDS crisis led to the need for antiretrovirals without cost as the first consideration. Last year, WHO put cancer and hepatitis C medicines on the list. Putting a drug on it is a “signal” that these drugs are essential and need to be accessible and affordable, he said, adding that it is for the panel to consider what to do make sure this is the case.

Developing Country Participation

A speaker underlined the difficulty for developing countries to participate in international norm setting. Those countries find it difficult to voice their real concerns and to articulate their position clearly. “In many occasions, we find ourselves at the other side of the world trying to discuss negotiated positions of developing countries… and we do not have enough tools or the capacity of meeting in other fora where we can build up our own way of looking at things, he said.

The way the norm-setting process is set is not conducive to the participation and benefit of developing countries, he said. He also underlined the issues relating to implementation. He referred to the issue of implementation of the flexibilities provided in the WTO Agreement on Trade-Related Aspects of Intellectual Property Rights (TRIPS), in particular compulsory licences. On the ground, he said, there is a lack of capacity to use compulsory licences.

“We need coherence and it starts with being able to play a role in the whole system,” he said.

Access to Ingredients, Quality, Regulations

A participant from Cipla Quality Chemical Industries, based in Uganda, talked about the sourcing of active pharmaceutical ingredients (APIs), raw material for generic pharmaceutical companies. They are currently sourced from India and to some extent China, he said. However, he said, going forward for new medicines, APIs will not be available from those two sources because of patent rights.

Uganda is a least-developed country and as such is exempted from WTO Agreement on Trade-Related Aspects of Intellectual Property Rights (TRIPS) obligations, he said. It will take some degree of cooperation on the part of the generator company to allow APIs to be made available for LDC manufacturers, but “we don’t know if that is possible now,” he said.

Alistair West from the UN Industrial Development Organization (UNIDO) said a key issue in access to medicines is quality. Generics can be a solution, he said, but quality needs to be ensured. There is a silent tragedy in Africa which relates to the lack of awareness of substandard medical products, said West, adding that some products may be legally licensed, but there is a lack of regulatory capacity.

A speaker from the Tanzanian commission on science and technology said that it is not an issue of lack of awareness but the scope of the task. “It is such a big war that we are fighting,” she said. In Tanzania, she said, there is mainland Tanzania and Zanzibar and there are some governance issues. Every day, tons of counterfeit drugs are seized and burned, but there are loopholes around seaports that render the task more difficult, she said.

Gopakumar from the Third World Network, speaking in the context of biosimilar medicines (which are follow-on products to biopharmaceuticals), said quality – though indispensable – could not constitute an entry barrier. He cited the 2009 World Health Organization Guidelines[pdf] on evaluation of similar biotherapeutic products, and said they include an obligation for the generic company to do clinical trials to comply with the guidelines, which state: “Head-to-head comparison of a biotherapeutic product with a licensed originator product with the goal of establishing similarity in quality, safety and efficacy.”

This head-to-head comparison implies that the generic company will have to buy the originator product, and that currently represents half the price of the biosimilar development, he said, keeping the prices high.

According to Gopakumar, WHO guidelines are answering the pharmaceutical companies’ concerns and prevent rather than encourage competition, and should be amended.

Coordination Needed

Other speakers suggested that the panel might advocate for the adoption of international norms forbidding retaliation. As a growing number of mechanisms funding research are being deployed, including private pharmaceutical companies, foundations, private prize systems, and product development partnerships (PDPs) the pharmaceutical eco-system is getting increasingly more complicated, one speaker said. There is a lack of coordination between the multiple players, which runs the risk of gaps in research with health threats being missed, and excessive duplication of research. The panel should identify opportunities for coordination, he said.

Delinkage

Professor Carlos Correa, a member of the panel’s Expert Advisory Group and director of the Center for Interdisciplinary Studies on Industrial Property and Economics at the University of Buenos Aires, presented the concept of delinkage. Patents grant monopoly, and the economic theory predicts that the price is established according to what the markets will bear, he said. This leads to a peculiar situation in the pharmaceutical industry where there is little relationship between the price of manufacturing medicines and the market price.

As an example, he cited a report evaluating the manufacturing cost for one gram of a Gilead treatment as between US$2 and 4, and one gram of the same medicines being sold in some countries for US$2,500. There is a chronic lack of transparency in R&D costs, he said, the costs are shrouded in mystery because this is a justification for high prices.

Correa mentioned ongoing discussions at the WHO on a possible R&D treaty, which could be a binding instrument, generating funding for R&D and setting priorities based on needs rather than on profitability. It is important to consider the issue of access to medicines at the multilateral level, he said.

James Love

James Love

James Love, director of Knowledge Ecology International, said there needs to be more forensics on why there is a single compulsory licence in India, and why Thailand stopped issuing compulsory licences.

The benefits of the delinkage conversation is that it is more of a mega-solution for patients. It takes the patient out of the system of funding R&D, he said. For the patients it is the best outcome. Regulating the monopoly is not working, he said, as “regulating the monopoly has been a failure.”

“We have to face up to the fact that there [are] not just market failures, but there [are] government failures, and one of them is the inability to regulate monopolies in the public interest,” said Love. “Delinkage is a political statement as well as a technical thing.”

New System rather than Revamping of Old

Peter Maybarduk, director of Public Citizen’s Access to Medicines Program, said Public Citizen helps countries introduce policies facilitating the adoption of compulsory licences. It is difficult for countries to act in isolation, he said, when the system protects commercial rights. The panel should operate independently of existing constraints, he said, and rethink from the ground up. It is not a matter of carving out space from the old system but putting on the table an ambitious proposal “to build the innovation system that we really want.”

Suerie Moon of Harvard said the structure of the pharmaceutical industry has to adapt to a changing environment, much like the software and computer industry did.

The structure has to respond to global public health needs, she said, adding that there needs to be a reflection on how pharmaceutical industries are structured and underlining that a lot of innovation is coming from academic laboratories and small companies.

What is really needed from industry is leadership, Moon said, on how to evolve and adapt, and how to deliver equitable access to medicines.

Industry: Patent System not Broken, Needs Tweaking

Jon Pender

Jon Pender

Jon Pender, vice-president of GlaxoSmithKline, commenting positively on proposals made to the panel, said however on some of them to “be careful what you wish for.”

“We need to insure that the new proposals are going to lead to more innovation than we see now,” he said. “The system under which companies operate is not absolutely perfect and no company is absolutely perfect, and there is always room for improvement.”

“It is important not to throw the baby out with the bath water in some of the proposals,” he said, underlining the number of significant medical innovations that have been put on the market in the last 50 years for the benefit of patients.

He said there is a role for delinkage, for example in the area of anti-microbial resistance, which includes a “complex series of factors.”

“My view is that the model is generally working, it is imperfect, there are areas where we can seek improvement,” said Pender. There were new solutions put forward that would have been unthinkable 15 years ago in terms of open innovation and open source approaches, and much more collaborative approaches, “and we need to see more of that,” he said.

“We don’t think the IP system is fundamentally broken but there are areas where we need to ensure that it does not become a barrier to access,“ he said.

He also warned against considering pharmaceutical companies as an homogeneous group. “It is far from that,” he said. “Even among the top 20 pharmaceutical companies, there are big differences within those companies and they represent a tiny fraction of the overall business.”

Pender, who appeared to be one of the only industry representatives to speak (and given that GSK CEO Andrew Witty is on the High-Level Panel), earlier in the day said the panel is very welcome.

But he did downplay the need for major changes. For instance, he noted the outrage that occurred several years ago when some shipments passing through Europe were seized on fear of patent violations. This turned out to be a problem of “overzealous” customs officials rather than a problem of the law, Pender said.

He made a point that while most medicines on the Essential Medicines List are freely available off patent, if one looks at the patient end it is seen that millions are still not getting them because of other factors (like infrastructure).

But he was followed by a South African patient who said she cannot access the medicine she needs and is now in palliative care because it is too late for her to get a biologic. She asked that non-communicable diseases like cancer get the same policies as HIV/AIDS.

Call for Reform of South Africa Patent Law, UN Watch List

A speaker said that patent law restricts innovation and encourages evergreening of patents. An important part of delinkage is also fixing the current patent law, she said, adding that South Africa needs to reform its patent law and implement TRIPS flexibilities.

“We face extraordinary pressure from the pharmaceutical industry and [some] …governments,” she said. The panel must recognise the pressure that countries are facing and there “must be some kind of mandate for governments and for pharmaceutical companies to act responsibly, because this is people’s lives that are at threat here,” she said.

She suggested some UN 301 watch list for “bad governments and all the pharmaceutical companies who are putting pressure on countries trying to use legally permissible” actions. “This is not radical, this is just legal things,” she said.

A South African academic said South Africa has not issued a single compulsory licence. Governments could issue automatic compulsory licences on everything on the WHO Essential Medicines List, he said.

Dreifuss: IP Rights Are Just Tools

In conclusion, panel co-chair Dreifuss said the issue of access to medicines is no longer a problem faced only by developing countries, but a global problem, and it is clear “we are all facing a problem of lack of innovation and high prices.”

However, a global view should respect the needs and differences of different countries, she said. She added that the issue is not only about medicines but also other medical products, such as diagnostics, which “are absolutely key in so many fields of public health.”

“We have to build on good practices and good experiences,” she said, see what was effective, and take into account the limitations of those models and how they should be corrected or upgraded. “We will also go new ways,” she said.

She said the panel will work towards better coordination between different stakeholders but also “inside the UN family and WTO” for better comprehension and collaboration.

“We are not authorised to consider IP rules are fundamental rights at the same level as human rights and right to health,” she said. “They are tools, tools that have proven in certain phases of history, in certain situations, for certain products or for certain types of problems, that they are good tools, they worked and they helped to realise what we expect from these tools but they are just tools.”

She concluded: “I think we need these tools probably, but I am sure we need also other tools, and we will try to welcome them.”

 

Source: IP Watch