Global Health Giants, Trade Deals, And IP Play Central Role In 2013 Public Health Policy

The role of intellectual property in a wide range of public health challenges – access to medicines, vaccine prices, procurement strategies, and research for diseases of the poor – is a focal point in 2013 cutting across national, regional, and international policymaking.

The advanced negotiations of several free trade agreements, and US president Barack Obama’s announcement that an US-European Union deal is a priority, have mobilised public health advocates, already speaking out about the associated risks of more aggressive IP restrictions. Meanwhile, the World Health Organization’s agenda is packed, but the slow pace of multilateral negotiations throws a spotlight on the influential role of other key public health actors including the Global Fund, Gates Foundation, and the GAVI Alliance.

Looming FTAs Cause Hope, Concern

US President Obama’s announcement during his 2013 State of the Union address that talks on an EU-US free trade agreement would start soon ignited concerns among public health advocates. They are raising concerns that such a deal would undoubtedly have a significant impact on IP, especially as it pertains to access to medicines.

Bryan Collinsworth, executive director of the Universities Allied for Essential Medicines (UAEM), told Intellectual Property Watch, “The trend in these agreements has been to aggressively expand IP restrictions, including data exclusivity and banning pre-grant patent oppositions, and we are particularly concerned about the impact this would have on biomedical research and new medicines.”

“If you have the two biggest economic forces coming together to set common IP standards, it will have a ripple effect globally, so it is very important to be careful of what is enshrined in these agreements,” Collinsworth said.

Also concerned about impending FTAs, the Médecins Sans Frontières (MSF, Doctors without Borders) Access Campaign is turning up the volume on how the Trans-Pacific Partnership Agreement (TPP) is shaping up to be “the most harmful trade pact ever for access to medicines in developing countries,” according to a MSF TPP policy brief. The next round of TPP negotiations, which are being conducted between the US and ten other Pacific region countries, will be held in Singapore from 4-13 March.

Additionally, MSF has raised concerns about the EU-India FTA, which has reached final stages of negotiations and is expected to conclude in April, following a round of negotiations in March. Katy Athersuch, MSF Access Campaign policy adviser, told Intellectual Property Watch, “IP enforcement provisions in the text go beyond TRIPS requirements and pose considerable risk to the export of affordable generic medicines produced in India.” TRIPS is the World Trade Organization Agreement on Trade-Related Aspects of Intellectual Property Rights.

Public Health at WTO and WIPO

Key public health issues will be addressed during the upcoming meeting of the WTO’s intellectual property committee from 5-6 March. A request submitted by Haiti on behalf of least developed countries (LDCs), WTO members will consider an extension for the implementation of TRIPS requirements for LDCs.

While LDCs have already been granted an extension until 2016, during which time they do not have to provide patent protection on medicines, Haiti’s request calls for the exception to apply “as long as the WTO Member remains a least developed country.”

Additionally, the issue of plain tobacco packaging will also be addressed during the upcoming TRIPS Council. In July 2012, the Dominican Republic launched a dispute regarding Australia’s national law blocking branding on tobacco products to discourage use. A high profile case, it puts the rights of intellectual property rights holders head-to-head with national health priorities (IPW, WTO/TRIPS, 26 February 2013).

The intersection of public health, innovation, and trade is increasingly apparent in multilateral policymaking. This notion was explored extensively in the recently published joint study by WTO, WHO, and WIPO called “Promoting Access to Medical Technologies and Innovation”.

A robust compilation of policy options available involving health, IP, and trade, the publication was presented to the WIPO Standing Committee on the Law of Patents (SCP) on 26 February as a reference for policymakers seeking to address health issues at WIPO. While some member states would like to see the book used as a basis for further analysis, it is unclear how it will be taken forward.

Seizing Opportunities to Advance R&D for the Poor

At the 132^nd WHO Executive Board session in January, Director General Margaret Chan memorably concluded the controversial agenda item on the financing of R&D for neglected diseases by telling member states they could “fight it out” at the next World Health Assembly (WHA, the annual meeting of WHO members, held in May).

Negotiations on the issue had heated up last November during an open-ended WHO member state meeting which took up the report of the Consultative Expert Working Group on Research and Development: financing and coordination (CEWG). The outcome of the meeting, a draft resolution, has been highly criticised by some non-governmental organisations (NGOs) and member states for lacking ambition and for a recommendation for “the adoption of the resolution by the WHA without re-opening it.”

Although WHO legal counsel confirmed that the resolution could be reopened, some member states, especially the United States, would likely put up tough resistance to the idea. In the meantime, some NGOs and member states are discussing how to best move forward with the proposals in the resolution including the establishment of a Global Health R&D Observatory within the WHO and setting up R&D pilot projects.

According to MSF, in order for the work of the Observatory to be meaningful, it should take a lead in identifying R&D gaps and proposing research priorities. Additionally, MSF suggested that the pilot projects build on the legacy of the Consultative Expert Working Group on Research and Development: Financing and Coordination (CEWG), focussing on the report’s key proposals, including advancing the principle of de-linkage, or separating the cost of R&D from the price of medicines.

These suggestions will likely be taken up during the Universities Allied for Essential Medicines (UAEM) Europe Conference to be held 19-21 April in Copenhagen.

As the Council on Health Research for Development (COHRED) celebrates its 20^th anniversary, the Geneva-based NGO will host a two-day meeting focusing on how investments in health research support the needs of low- and middle-income countries. The COHRED Colloquium 2013 will be held in Geneva from 26-27 March in partnership with the Lancet journal.

Carel IJsselmuiden, COHRED executive director, told Intellectual Property Watch, “Health research and innovation are a major driver of development. As we reach an important crossroads where so much progress had been made, yet donor contributions are diminishing, we wanted to look at how to maximise investments and how to get lower- and middle-income countries to invest in their own R&D.”

Additionally, COHRED is advancing a Fair Research Contracting initiative to empower entities in low- and middle-income countries engaging in R&D partnerships with entities in developed countries. “The growing volume of research in these countries and North-South partnerships has revealed a need to support institutions lacking the capacity to effectively negotiate fair contract terms from the outset,” Debbie Marais, COHRED programme director, told Intellectual Property Watch, and said that a guide on negotiating contracts should be available by July.

Meanwhile, a proposal on clinical trials regulations in the EU could lead to greater access to clinical studies reports and medical research data. A report on the proposal, submitted by Parliament Member Glenis Willmott, is expected to go to vote on 24-25 April at the European Parliament. Health Action International (HAI) has been following the issue closely and says that passage of the proposal would an important step for the promotion of open access to medical research in Europe.

Katrina Perehudoff, European project manager for HAI Europe, told Intellectual Property Watch, “It’s a balanced approach which would provide more information to avoid waste and unethical research, while protecting truly confidential information for companies and safeguarding the personal data of patients.”

The Medicines Patent Pool, a Geneva-based group working to increase access to affordable, high-quality medicines for HIV/AIDS patients in low and middle income countries, announced a new collaboration with ViiV Healthcare, a joint venture between GlaxoSmithKline, Pfizer, and Shionogi, on 27 February. The deal provides for access to a paediatric formulated HIV medicine in 118 countries under one patent license. MPP also announced, in a media release, that the organisations have agreed to negotiate additional licences in the future, and the group is in negotiations with other companies.

Global Fund: Replenishment, Procurement, and New Funding Model

With most reforms complete and new management in place, the top priority for the Global Fund to Fight AIDS, Tuberculosis and Malaria this year is raising money. The new Executive Director, Mark Dybul, will oversee the 4^th Replenishment Process for the period of 2014-2016, with the big donor conference to be held in September or October.

Seth Faison, communications director of the Global Fund, told Intellectual Property Watch, “The challenge is persuading everyone to make long-term investments instead of short ones. We have made all of these gains in HIV, Malaria and TB and if we can’t go forward to defeat these diseases now, then governments and countries will be paying for it for a long time to come.”

The Geneva-based organisation has not yet gone public with resource requirements, but the amount will likely be announced during the first replenishment meeting, which will be hosted by the European Commission in Brussels from 8-9 April. Another key event this year is the Board Meeting to be held 18-19 June in Sri Lanka, which will be a first for Dybul. Former Fund General Manager Gabriel Jaramillo, who spearheaded the reform, had his last day on 18 February.

With 40 per cent of grants going toward the purchase of pharmaceuticals and other health products, there has been growing interest in how reforms made to the Fund’s Voluntary Pooled Procurement mechanism will roll out this year. Faison described the new approach as “very smart, very efficient, and very private sector,” saying the changes will “reinforce ownership of the supply relationship, incentivise registration, and innovate purchasing strategies.”

In recent weeks, concerns about US and pharmaceutical industry influence in the Fund’s procurement polices came to a head with the publication of a letter written in April 2011 by US Senator Orrin Hatch to then-Secretary of State Hillary Clinton. In the letter, he criticised the Fund’s policy of promoting the procurement of generic medicines and the use of compulsory licensing (IPW, Public Health, 12 February 2013).

Aidspan, an independent observer of the Global Fund, will be following how the policy reform affects procurement at the country level, according to a procurement specialist there. Additionally, the Kenya-based NGO will be watching the new funding model, [update]: which was just launched [end of update], especially how the country dialogue proceeds, how the first round of countries, the so-called “early applicants,” find the new process, and how quickly the Fund will be able to get out new grants.

Promoting “Global Access” at Gates

It is difficult to quantify the importance of the Bill and Melinda Gates Foundation in public health today. But the amount the Foundation provides in donations to the Global Fund, the GAVI Alliance, HIV research, and beyond, rivals or surpasses the aspirations of most governments, especially in a currently difficult economic landscape. After several email and telephone requests, the Foundation’s media relations team declined an interview for this story.

However, Oxfirst, a UK-based consulting firm specialised in the economic aspects of innovation, provided an opportunity to focus on how the Gates Foundation manages IP issues during its first webinar, hosted at the University of Edinburgh, on 24 January. Richard Wilder, associate general counsel at the Foundation, gave a talk on “Managing Intellectual Property for Public Health.”

Highlighting the organisation’s various partnerships and funding options, Wilder said that “managing IP to achieve global access” is a priority regardless of the collaboration type. As the Foundation supports many different kinds of initiatives at various stages of the R&D life cycle, specific provisions on data sharing, cross licensing, and access to materials can vary per contract.

Wilder told Intellectual Property Watch, “The aim of the global access objective is that ultimately the project results are made available and accessible to people in developing countries.”

Capturing IP Benefits in WHO “Partnership Contributions”

WHO negotiations with pharmaceutical companies to ensure that fair contributions are made for the use of WHO biological materials for R&D will continue this year. The Pandemic Influenza Preparedness (PIP) Framework Advisory Group will meet 20-22 March in Geneva with pharmaceutical company and civil society consultations on the first day.

During the January 2013 Executive Board meeting, WHO Director General Chan praised progress that has been made so far on pandemic flu preparedness, noting that the first Standard Material Transfer Agreement 2 (SMTA 2), a contract that allows the sharing of viruses with entities outside of the traditional WHO system, was signed with GlaxoSmithKline in December. In the deal, the company agreed to give WHO access to 10 per cent of its total production of pandemic vaccines. Additionally, six companies have already made their “partnership contributions” of more than USD$18 million to the WHO biological material sharing system, even though the formula has not yet been agreed.

Discussions on how to calculate partnership contributions will continue during the next PIP Advisory Group meeting to be held on 21 March in Geneva. The International Federation of Pharmaceutical Manufacturers and Associations (IFPMA) made a proposal [PDF], using a weighted combination of seasonal, pre-pandemic, and pandemic vaccine production to determine assessments.

While the proposal was generally well received, some members of civil society raised concerns that by asking contributions only of manufacturing entities, some companies who also benefit from the system, through the licensing of intellectual property, for example, would be missed. The Third World Network and Berne Declaration submitted a letter [PDF] to the PIP Advisory Group following the PIP Advisory Group’s last meeting in October 2012 detailing their concerns, including specific examples of how non-producing entities also benefit.

One such example was the US-based company Novavax, which holds IP rights on “virus-like particles and vaccine production technology that includes claims over PIP biological materials.” Although the company has yet to commercialise a product, it has licensed its technologies for use in other countries. Therefore, the letter suggests “the Advisory Group and WHO define appropriate mechanisms to ensure that any entity that uses GISRS [Global Influenza Surveillance and Response System] and benefits from the use makes a partnership contribution.”

On poor quality medicines, WHO member states need to move forward on key action items in order to advance the so-called mechanism on “substandard/spurious/falsely-labelled/falsified/counterfeit” medical products (SSFFC) before the WHA. During the last Executive Board meeting, members agreed to convene a one-day meeting on the SSFFC mechanism, set up a steering committee, name a chairperson, and establish a working group to identify the actions, activities, and behaviours that result in SSFFC medical products (IPW, WHO, 28 January 2013). According to the WHO secretariat and member state delegates, further decisions have not yet been taken on these items, nor are any additional details available.

Keeping Vaccine Prices in Check

At the last WHO Executive Board, member states took note of Monitoring and Evaluation/Accountability Framework seen as an important element in the implementation of the Global Vaccine Action Plan. Concerned about the rising price of childhood vaccines, MSF has called for the inclusion of a vaccine pricing indicator, which could be based on the percentage change of the cost of a fully immunised child as per WHO’s recommended Expanded Programme of Immunization (EPI). MSF says that the issue of pricing is especially important as countries lose eligibility for GAVI Alliance support.

According to GAVI, 17 countries are in the process of graduating in the coming years. The cost of immunisation is also a key concern for the organisation as it works to shape vaccine markets through its supply and procurement strategy and secure a diverse base of manufacturers. An important year for vaccines, GAVI will launch new vaccines in 50 countries this year [clarification]. The importance of vaccines will be highlighted by an international push to stamp out polio and a strong emphasis on routine vaccinations generally.

“The pace of the GAVI Alliance’s work continues to accelerate in 2013 with a larger number of vaccine introductions, price reductions, active shaping of the vaccines market and strengthened partnerships with countries.” Seth Berkley, GAVI Alliance CEO, told Intellectual Property Watch.

Promoting Access to New NCD Meds

Preventing and controlling non-communicable diseases (NCDs) – especially diabetes, cancer, cardiovascular and respiratory diseases – will continue to top the public health policy agenda this year with WHO member states finalising the 2013-2020 NCD Global Action Plan (GAP). The WHO Secretariat recently released a revised draft of the GAP, which is available for public comment via online consultation. From 6-17 March, the WHO will hold informal consultations with NGOs and the private sector on the revised draft, following which there will be informal consultations with member states from 11-12 March.

The GAP should be finalised at the 66^th World Health Assembly, which will be held 20-28 May, with the possibility of an “omnibus resolution.” This would combine it with other NCD policies, including the Global Monitoring Framework (GMF). Comprised of nine voluntary global targets and 25 indicators on the prevention, control and treatment of NCDs, the GMF was endorsed at the last Executive Board meeting.

Although improving access to NCD treatments and IP barrier issues have not played a central role in policy discussions so far, the next generation of medicines to treat these diseases, especially cancer, are extremely expensive. UAEM has been particularly vocal about these challenges, calling on member states to prioritise access to NCD treatments.

UAEM’s Collinsworth told Intellectual Property Watch, “The conventional wisdom has been that IP is not an issue as most NCDs can be treated with off-patent medicines. But the latest generation of many NCD medicines are out of reach due to high prices, and access will continue to be an issue going forward as more effective treatments are developed.” He pointed to a recent article published in the Lancet, with authors including Rachel Kiddell-Monroe, UAEM’s president, and member Sandeep Kishore, discussing IP challenges for NCD treatment access.

Important to a range of public health issues, 2013 is also an important year for priority setting as policymakers look toward the post-2015 Development Agenda. A key meeting co-led by WHO and UNICEF will be held in Botswana from 5-6 March where 50 representatives of governments, the UN system, civil society, and the private sector will participate.

Related articles:

http://www.ip-watch.org/2013/01/28/debate-erupts-at-who-over-consensus-on-financing-rd-for-the-poor/print/

http://www.ip-watch.org/2013/01/30/who-executive-board-concludes-after-unpredecented-workload/

http://www.ip-watch.org/2013/01/28/who-board-approves-resolution-on-neglected-diseases-sets-next-meeting-on-substandard-medicines/

http://www.ip-watch.org/2013/01/28/who-plan-for-pandemic-flu-proceeds-with-questions/