IP, R&D Among Issues In Packed Agenda Of 2014 World Health Assembly

The annual World Health Assembly kicks off next week with a full agenda of new and old public health issues, including several related to intellectual property, pricing, and research and development. Below is a guide to the key issues for Intellectual Property Watch readers.

The 67^th WHA takes place from 19-24 May. The provisional agenda is here.

All WHA documents are here: http://apps.who.int/gb/e/e_wha67.html

Daily updates of the agenda will be posted here: http://apps.who.int/gb/ebwha/pdf_files/WHA67/A67_JourP-en.pdf

Among the headlining newer issues are non-communicable diseases (like cancer), antibiotic resistance, tuberculosis, and health in the UN post-2015 development agenda. Another top issue includes the ongoing reform of WHO related to management, oversight, human resources, and closer engagement with “non-state actors” such as industry and philanthropic foundations.

Issues of relevance to followers of intellectual property, innovation, and R&D include the latest on the slow-moving attempt to find alternative ways to finance R&D for neglected diseases predominantly affecting poor populations (unable to afford fully priced medicines).

It also includes a draft resolution on access to medicines, the framework on pandemic influenza preparedness, and progress on counterfeit and substandard medicines.

Access to Essential Medicines

The WHO membership will consider a resolution on access to medicines based on a secretariat report, document A67/30 [pdf].

The report describes efforts, such as the WHO Model List of Essential Medicines, aimed at promoting better “management of medicines, more cost-effective use of resources and higher-quality health care, and their effective implementation [which] will increase access to medicines, avoid high out-of-pocket expenses, facilitate progress towards universal health coverage and achievement of the health-related [UN] Millennium Development goals, and ensure the effective treatment and care of noncommunicable diseases.”

The report says that despite efforts, “problems with the low availability and affordability of essential medicines in low and low-middle-income countries remain.”

The report discusses strategies related to generics, pricing, reporting and data at the national level, and supplies, and lists a range of activities being undertaken to promote access to essential medicines. Examples are local innovation and universal health coverage.

Separately, the WHO this week released a new study on “Increasing access to HIV treatment in middle-income countries: key data on prices, regulatory status, tariffs and the intellectual property situation.” The study is not directly tied to the WHA but may receive significant attention. A separate IP-Watch story to follow will take a more in-depth look at the findings.

CEWG

On R&D financing for neglected diseases, members will be asked to consider the follow-up of the report of the Consultative Expert Working Group on Research and Development: Financing and Coordination (CEWG). Document A67/27 [pdf] includes a report on work mandated by the past WHA, including setting up a Global Health Research and Development Observatory for collecting and sharing information, on which the secretariat said work has begun. This includes some mapping of stakeholders, work on databases, and holding of consultations.

The report also notes that “while there is currently no existing mechanism that coordinates health research and development at the global level,” there are “numerous” mechanisms on coordination with specific disease areas. The WHO secretariat reviewed these and identified three models for consideration by member states.

They are: “passive coordination achieved through better sharing of information; active coordination through networks of researchers agreeing on priorities and collaboration; and managed coordination through formal structures to manage the research undertaken and the allocation of resources to support them.”

The document discusses the possibility of “pooled funding” for R&D, which would be able to receive voluntary funding, including from governments, manage and disburse funds to private or public entities to finance research, and put in place an access policy to ensure resulting products are affordable in countries in need.

The report focussed on existing mechanisms that could pool funding for health R&D. It excludes national organisations or those created by an individual or company, such the Bill & Melinda Gates Foundation or the Wellcome Trust. But it listed more than a dozen potential organisations, such as the GAVI Alliance, UNITAID, and the Global Fund, giving short reasons why they were included, and laying out the criteria used. The report includes an annex on product development partnerships.

The next step, should member states decide to pursue the possibility of a pooled fund, would be to determine whether any of the most-qualified organisations would be willing to take on such a task, the report said.

A second related document A67/28 [pdf], describes four health R&D demonstration projects that were chosen from a much longer list of possibilities. Four other projects were listed as possible and will be further examined in a future meeting. The document provides the indicators used to select the projects, and for future measurement of success.

The four demonstration projects chosen by many accounts are a pale reflection of the once-bold initiative undertaken by WHO to address the market failure for such medicines. But others insist that these demonstrate innovative ideas for funding that could lead to new ways of addressing the problem. The four projects are:

1) The Visceral Leishmaniasis (VL) Global R&D & Access Initiative (proponent: Drugs for Neglected Diseases initiative)

2) Exploiting the pathogen box: an international open-source collaboration to accelerate drug development in addressing diseases of poverty (proponent: Medicines for Malaria Venture)

3) Development of Class D CpG oligodeoxynucleotides (D35) as an adjunct to chemotherapy for cutaneous leishmaniasis and post kala-azar dermal leishmaniasis (proponents: United States Food and Drug Administration et al.)

4) Development for easy to use and affordable biomarkers as diagnostics for types II and III diseases (proponents: African Network for Drugs and Diagnostics Innovation et al.)

The WHO Special Programme for Research and Training in Tropical Diseases (TDR) published an article this month on “New R&D models in neglected diseases under review.” The article, which describes the new proposals set out by TDR, is available here.

SSFFC

Substandard/spurious/falsely labelled/falsified/counterfeit. That is how the WHO members continue to refer to the issue of fake and poor quality medicines. There has been disagreement on this issue in the past, but it is moving. This Assembly has before it document A67/29 [pdf], the report of the second meeting on member state mechanism on SSFFC. The rotation of the mechanism chair will continue in the absence of agreement on a chair, and current chair Nigeria will stay in place until the end of this Assembly, then a chair from the Americas will be chosen until the end of the 2015 WHA.

The report includes a non-exhaustive list of behaviours, activities and actions that lead to SSFFC medical products.

The next meeting of the SSFFC mechanism is proposed for the week of 27 October 2014, followed by a steering committee meeting.

Pandemic Influenza Preparedness

Under the WHO Pandemic Influenza Preparedness (PIP) Framework for the sharing of influenza viruses and access to vaccines and other benefits, member states will consider a report from the director general. This reports on a mandated annual partnership contribution to be paid to WHO by manufacturers of influenza vaccines, diagnostics and pharmaceuticals using the WHO Global Influenza Surveillance and Response System.

The distribution of Partnership Contribution resources among companies was to be based on transparency and equity, according to their nature and capacities, the report notes.

For 2013, the WHO secretariat identified 37 companies that were to contribute the total annual Partnership Contribution of US$ 28 million. The amount to be paid by each company was determined by using the approved methodology and formula.

Document A67/36 [pdf] includes a report from an October meeting of the PIP Framework Advisory Group, and an overall report on progress from the advisory group. As of October, there were two standard material transfer agreements (SMTAs) signed, governing transfer of biological material to vaccine manufacturers, with others under negotiation. It also mentioned a discussion synthetic biology.

Several more agreements were reported at the next meeting of the advisory group, held in April 2014, and reported on in document A67/36 Add.1 [pdf].

At this meeting, a technical expert working group on genetic sequence data gave a preliminary report. It described the usefulness of such data and the importance of maintaining the principles of fair access and benefit-sharing.

The April report also gave an update on the Partnership Contributions, stating that $26 million had been raised from 24 companies, and the remainder were being pursued. It raises problems with collecting the funds, and makes suggestions for improvement.

The next meeting of the PIP Framework Advisory Group is scheduled for October 2014.

Non-State Actors

One of the most talked-about issues of the past year at WHO, the organisation has laid out its draft plan for allowing closer involvement of industry, foundations and others in its activities. The “framework of engagement with non-state actors” is WHA document A67/6 [pdf].

The draft plan includes numerous limitations on such involvement, aimed at ensuring the independence, credibility and transparency of the organisation. It states that member states still hold the final say on everything. But it would allow changes such as letting “privileged” actors sit in on governing bodies (with non-voting status but with the right to speak), and allows industry representatives hold to positions within the organisation (on “secondment”).

Non-state actors are delineated as: NGOs, private sector companies, international business associations, philanthropic foundations, and academics. Industry representation could amount to a significant proportion. NGOs can have commercial interests as long as it is not “primarily” about profit-making. International business associations represent the private sector but appear to get separate consideration, seemingly giving business two “bites at the apple”.

WHO also can accept funds from foundations under conditions (including that the funds fit to the mandate given by the World Health Assembly, and that it avoid over-reliance on one funding source).

The new era for WHO and non-state actors was heralded in a couple of years ago when Bill Gates stood on stage with WHO Director General Margaret Chan raising their arms together in celebration. At this year’s WHA, Gates’s wife Melinda Gates is a special invited speaker.

Communicable Diseases

Another rising issue is hepatitis, with particular new attention to prices of hepatitis C treatments. The WHA is asked to consider a draft resolution on improving the health of patients with viral hepatitis. The report was updated from the January Executive Board meeting to now to include references to pricing, highlighting access to appropriate medicines as a barrier and finding that new treatments come at “significant cost.”

The report on hepatitis, A67/13 [pdf], offers a suggestion that captures the spirit of current discussions at organisations such as UNITAID and the Medicines Patent Pool, Global Fund for AIDS, Tuberculosis and Malaria, and the private sector. It states: “A combination of approaches will need to be considered, such as voluntary licensing to generic manufacturers and tiered pricing of the branded medicine linked to a country’s income level.”

On tuberculosis, the members are presented with a draft resolution on a global strategy and targets for tuberculosis prevention, care and control after 2015, A67/13 [pdf].

On the Global Vaccines Action Plan, adopted at the 2013 Assembly, members will be given a progress report, A67/12 [pdf].

The 2013 Assembly highlighted concerns over vaccine prices around the world, and a special working group was supposed to look into the matter this year (IPW, WHO, 28 May 2013).

In an unrelated area, members are asked in document A67/26 [pdf] to adopt a strategy on traditional medicine for 2014-2023 that includes the objective of building a knowledge base and working on issues of quality.

Non-Communicable Diseases (NCDs)

NCDs include cancer, diabetes, cardiovascular and respiratory diseases. An increasingly dominant issue at the WHO over the past few years, the WHA will be asked to consider terms of reference for a global coordination mechanism on the prevention and control of NCDs, A67/14 Add.1 [pdf].

Document A67/14 Add.2 [pdf] is a report from the director general on WHO’s role in the preparation, implementation and follow-up to a high-level meeting of the UN General Assembly to undertake a comprehensive review and assessment in 2014 of the progress achieved in the prevention and control of NCDs.

In document A67/14 [pdf], members are presented with a proposal for a wide-ranging UN Inter-Agency Task Force on the Prevention and Control of Non-communicable Diseases, including division of responsibilities.

The WHA also will be asked to consider a set of “action plan indicators” for the WHO Global Action Plan for the Prevention and Control of Noncommunicable Diseases 2013–2020, and to adopt the nine action plan indicators contained in the related report.

The WHA will further consider a report on implementation of the 2008-2013 action plan for the global strategy for the prevention and control of noncommunicable diseases.

Separately, as always, there are numerous side events and special activities alongside the WHA as well.