Update from the World Health Assembly – May 20

Live Twitter updates from the 62nd World Health Assembly:  www.twitter.com/patientspatents

Discussions on issues of public health and innovation have been further delayed.  They were to be discussed yesterday, but have been rescheduled for later today.  With other issues such as climate change, social determinants of health and pandemic influenza preparedness also on the agenda, it seems likely this could be further delayed.

This morning, delegates in the Committee A meeting endorsed a resolution on the prevention of avoidable blindness and visual impairment, which will be brought to the attention of the full Assembly.

The revised meeting schedule is available on the WHO site.

Members of WHO Expert Working Group on R&D Financing announced

IP Watch reports that the World Health Organization has released a long-awaited list of high-level experts tasked with finding innovative funding mechanisms for needed medical research on neglected diseases. The list largely contains governmental and intergovernmental representatives.  The list of Expert Working Group members is available from the WHO website.

This group will examine current financing and coordination of research and development, as well as proposals for new and innovative sources of funding to stimulate research and development related to Type II and Type III diseases and the specific R&D needs of developing countries in relation to Type I diseases.

The group includes representatives from developed and developing nation governments, international organisations, think tanks and academia. The group is expected to report to the WHO Executive Board meeting in January 2009.

Some initial commentary on the Working Group includes:

• A developed country official said it is “a pretty good group” and “I look forward to following their work.”
• Richard Kjeldgaard, associate vice president for international intellectual property at the Pharmaceutical Research and Manufacturers of America, said the group looks “forward to working with the expert group as they examine proposals for new and innovative funding sources” aimed at addressing developing country needs. 
• Sisule Musungu, president of think tank IQsensato, cautioned that high credentials alone “will not resolve the question, since the problem requires interdisciplinary analysis… and thinking ‘outside the box.’” The group’s “willingness to learn” and to “listen to a variety of ideas” will be critical, he added.

Director of PAHO blogs about annual meeting, public health and innovation

The Director of the Pan-American Health Organization (Mirta Roses) stated in her blog that this year’s PAHO assembly would focus particularly on matters related to innovation and research.  ”Proposals for action to strengthen vital and health statistics, as well as the link between public health, innovation, and intellectual property, are part of our integral efforts to promote evidence-based policies.”

The debate around ensuring access to safe medicines and protecting strong incentives for continued medical innovation is of the utmost importance to patients around the world.  It is unfortunate that, more than a month after the annual meeting, PAHO seems to be maintaining the same secrecy as did the World Health Organization in the development of their Intergovernmental Working Group on Public Health, Innovation and Intellectual Property.  As PAHO further explores these issues, it is essential that patients be included in the process.

Director of PAHO’s Blog
The Home for Health in the Americas strengthening actions in public health and improving the social protection in health for our populations.

This week we are celebrating at our Headquarters, which I also call the Home for Health in the Americas, the 48th Directing Council of our Organization, in which all the Member States participate. At the opening session, we had the good fortune to have with us Dr. Margaret Chan, Director-General of the World Health Organization, His Excellency José Miguel Insulza, Secretary-General of the Organization of American States, and representatives from the other institutions of the Inter-American system, the observer states, and agencies and entities that cooperate with our efforts.

The Council’s intense agenda, which will occupy the entire week, will focus particularly on matters related to innovation and research. Proposals for action to strengthen vital and health statistics, as well as the link between public health, innovation, and intellectual property, are part of our integral efforts to promote evidence-based policies.

We are taking this action because our commitment, each of us in his own area but conscious that all of us are connected to one another in a network to improve public health, is to get results. This demands self-criticism to examine the progress made toward meeting noble and ambitious targets, such as those in the Development Goals of the Millennium Declaration, and timely action to adopt the measures necessary for meeting them, such as the Regional Strategy and Plan of Action for Neonatal Health within the Continuum of Maternal, Neonatal, and Child Care. It also demands solidarity among the Member States, a distinctive feature of public health in our Region, exemplified once again in the recent launch of the Action NOW for the Lives of Mothers, Newborns, and Children Initiative, a notable example of horizontal cooperation and solidarity among developing countries that is supported by the Prime Minister of Norway and a network of political leaders, headed in our Region by President Bachelet and President Lula. I congratulate Dr. Chan on the success of her activities in this area in New York last week, and I thank all the many government authorities and First Ladies of the Region, who have made the improvement of maternal, neonatal, and child care a high political priority.

Solidarity also implies a resolute struggle against inequity and poverty and their terrible consequences for public health. For this reason, activities to promote social protection and equitable access to quality health services are moving forward. Examples of these are proposals to make progress in the elimination of neglected diseases and in staunch promotion of the primary health care strategy, as well as support for the priority countries, with special emphasis on collaborative health efforts in Haiti.

It is clear that measures to reduce the risk and burden of disease, among them the Regional Strategy and Plan of Action for Cervical Cancer Prevention and Control and efforts for the prevention and management of diabetes and obesity, should be viewed in the context of health determinants and actions to address them. Therefore, the agenda also includes climate change and its impact on public health, a phenomenon that has been the focus of much of our effort this year (to which I have referred in other blogs) and that, as the latest evidence reported some days ago reveals, is intensifying at a rate that exceeds even the grimmest scientific forecasts. The consequences are, unfortunately, very real. Some Ministers of Health, understandably, could not participate in the meeting because they are grappling with the consequences of the severe hurricane season in the Caribbean.

We have major challenges ahead of us, then, as well as opportunities that the participants in this meeting of the Directing Council will address with the sense of responsibility and commitment characteristic of people devoted to the mission of public health. I am certain that this week of working together in solidarity will lead to new successes in public health in the Region.

Mirta Roses

WHO offers few details on progress of global health and IP strategy

IP Watch released the following report on the World Health Organization’s Intergovernmental Working Group on Public Health, Innovation and Intellectual Property and their lack of transparency:

Work is ongoing within the World Health Organization on a member-mandated global strategy on public health, innovation and intellectual property, a WHO official said Tuesday. But little information about that work has been forthcoming since the strategy was approved in May.

The “silence of the WHO doesn’t mean we haven’t been doing work,” said Malebona Precious Matsoso, who directs the WHO Department of Technical Cooperation for Essential Medicines, speaking at an informal seminar hosted by IQsensato on 23 September. “We are cautious; we cannot communicate things that have not been formally recognised.”

…much work lies ahead on key decisions contained in the global strategy and plan of action. This includes assessing priority needs of developing countries in medical research and development, improving developing country capacity for R&D, and implementing alternative funding strategies to stimulate R&D.
Matsoso said that the WHO had “consciously identified those partners we think need to work with us” and that the organisation had had several meetings with different stakeholders.

She later explained that many of these stakeholders were researchers, often in developing countries, as well as public health associations, doctors and distributors of medicines. These are people, she said, whose day-to-day work will be affected by WHO decisions but who may not understand the implications of those decisions. They often “come back to us saying they need their own assemblies to assess” the document, she added.

Matsoso also said the WHO is working on a “matrix” detailing what activities mentioned in the global strategy already exist, what activities need scaling up, and what activities constitute new work, so that the organisation can decide out how to budget the programmes. “We’re hoping to finalise it soon and share it with you,” she said.

http://www.ip-watch.org/weblog/index.php?p=1241

What was the final outcome of the IGWG anyway?

After all the talk, all the negotiations late into the night, all the lobbying and the mud slinging, what actually happened to the IGWG at the end of the 61st World Health Assembly – and what does it mean for patients around the world? 

According to the WHO web site, the “Global Strategy on public health, innovation and intellectual property endorsed by the 61st World Health Assembly is designed to promote new approaches to pharmaceutical R&D and to improve access to medicines. It also provides a framework for enhancing and making sustainable essential R&D relevant to diseases impacting developing countries”.

So… what does that mean? What final document was tabled, and what areas are still under debate?

According to the WHO web site:

• The Global strategy was approved by the World Health Assembly; 
• The plan of action was also approved, except for 9 actions, which remain “open”; 
• In the short term, the WHO will prepare a ‘quick start’ programme and will begin to immediately implement the elements of the global strategy that fall under its responsibility;
• The WHO will finalize the outstanding components to the plan of action;
• The WHO will estimate the cost implications of the plan;
• The WHO will establish (yet another) expert working group to examine current financing and coordination of R&D, as well as proposals for new and innovative sources of funding to stimulate R&D.

The implications of this strategy for patients around the world remain to be seen.  What is clear, is the important role that patients around the world should be playing in these discussions on global innovation and access to medicines.  In an ideal situation, the WHO will acknowledge patients as the key stakeholder in global health and invite patients and their advocates to join the discussion.  Until that happens, patients and patient advocates should take every opportunity to engage their regional representatives, WHO officials and each other in this important dialogue.

Report on the IGWG

The World Health Organization recently posted a news release stating that:

the <World> Health Assembly produced a public health breakthrough by providing a platform for removing barriers and using innovative methods to encourage research, development and access to medicines for the common diseases of the developing world.

The public health, innovation and intellectual property strategy endorsed by the Health Assembly is designed to promote new approaches to pharmaceutical research and development (R&D), and to enhance access to medicines. It is also designed to provide a medium-term framework for enhancing and making sustainable essential R&D relevant to diseases impacting developing countries.

According to the WHO’s report on the IGWG, Member States agreed to encourage the application and management of intellectual property in a way that maximizes health-related innovation and access.  Other components of the strategy, endorsed by the Member States include:

• An assessment of health needs in developing countries and identification of research and development priorities;
• Promotion of research and development on diseases which substantially or overwhelmingly affect people in developing countries, and also diseases which affect rich and poor countries with large numbers of vulnerable populations in both; 
• Exploration and implementation, where appropriate, of possible incentive schemes for research and development; 
• Improvement of research and development capacity in developing countries; 
• Improvement, promotion and acceleration of technology transfer; 
• Improvement of access to all health commodities by effectively overcoming barriers to access; and 
• Sustainable financing for R&D in developing countries.

The short-term follow-up actions from the World Health Assembly are for the WHO to:

• Prepare a quick start programme with adequate budget provision and begin immediately to implement the elements of the global strategy that fall under its responsibility;
• Finalize the outstanding components of the plan of action and estimate the cost implications of the plan; and
• Establish an expert working group to examine current financing and coordination of research and development, as well as proposals for new and innovative sources of funding to stimulate research and development.

What does this outcome mean for patients around the world? 

At this point, the answer to that question remains unclear as the discussion on financing and strategic implementation will continue over the next year at least.  Hopefully, the WHO will engage patients in these discussions.

Patents are the wrong target

Much as the WHO’s IGWG draft strategy on public health, innovation and intellectual property remains unfinished with the close of the 61st World Health Assembly, so does the global discussion on this important topic.

Benetto Della Verova, a member  of the Italian Chamber of Deputies, writing in the International Herald Tribune (‘Patents are the wrong target’ ) examines some of the significant issues that remain unresolved by the World Health Organization’s  deliberations on the recommendations of the Intergovernmental Working Group on Innovation and Public Health ( IGWG).

When the World Health Assembly met in Geneva last week, scores of nongovernmental organizations descended on the city to lobby for a new cause in global health care: eliminating the patent system.

Faced with the knowledge that 30 percent of the world lacks access to life-saving medicine, advocates like Doctors Without Borders and Oxfam have marshaled their forces to convince members of the World Health Organization to scrap the patent system. They believe their efforts will increase access to vital pharmaceuticals in the third world.

However, while no one would question the motives of these groups, if they are successful they will endanger the lives of the very people they are trying to help.

Well-meaning NGOs oppose patents because the temporary monopoly that patents provide allows pharmaceutical companies to charge high prices for their medicines. What these NGOs fail to consider is what would happen without patent protection.

Development of pharmaceuticals is among the most expensive and risky business propositions in the world. Only .02 percent of chemical compounds tested by a pharmaceutical company will ever go to market. Each drug takes 10 years to develop and costs about $1 billion. And of the few medicines that do eventually reach consumers, 70 percent will never be profitable.

Without the protection of patent rights it would be impossible to ever turn a profit developing new medicines.

Rather than attacking the patent system, these NGOs should focus on the real obstacles to getting patients the medicine they need.

Poverty is, of course, the greatest threat to world health. In poor countries about 45 percent of the cause of disease is related to poor nutrition, indoor air pollution, and lack of proper sanitation. Poverty also impedes access to pharmaceuticals, but not just because of price.

“It is very obvious that the elephant in the room is not the current price of drugs,” according to Kevin De Cock, the director of WHO’s HIV division, in 2006. “The real obstacle is the fragility of health systems. You have health infrastructure that is dilapidated, and supply chains that don’t exist.”

Poor nations lack the infrastructure needed to distribute drugs. Good doctors, nurses, and hospitals to administer the drugs properly are also lacking. In fact, according to one World Bank study, education, distance, culture, and other factors that affect the demand for medicine may be more important determinants of access than price.

Without correcting these basic problems, reducing the price of pharmaceuticals will have a negligible impact on the availability of drugs worldwide.

Of course, price is not irrelevant when it comes to accessing medicine. But even here patents do not deserve all the blame. Governments have erected unconscionable tax burdens on medicine. Taxes, duties, tariffs, and markups by government procurement agencies all inflate the cost of drugs. In some countries these policies contribute more to the final price than the manufacturer’s price.

These taxes contribute little revenue and harm the most vulnerable members of society. Eliminating them would be a low-cost means of expanding access to medicine.

In addition to eliminating these government-created price increases, there are a number of reforms that can be undertaken to increase access without eliminating the patent system that ensures continued research and investment in pharmaceuticals.

Strengthening the patent systems in the third world would encourage pharmaceutical companies to invest in medicine to combat the diseases of poverty.

Governments could work to expand pre-existing incentives for research in neglected disease. The U.S. Orphan Drug Act, enacted in 1983, provides tax credits and market exclusivity for developing treatment for rare diseases. Annual creation of new treatments for rare diseases was 12 times greater in the 16 years following the passage of the Orphan Drug Act than in the previous decade. The success of the legislation has led to similar models in Japan and the European Union.

Researchers at Duke University have proposed a voucher system that would reward companies that develop new treatments for neglected diseases with vouchers for a Federal Drug Administration “priority review” of any other drug. This voucher would potentially increase revenue by hundreds of millions of dollars. Part of these revenues could be used by companies for philanthropy toward third world countries to help them in acquiring patent products. Vouchers could even be paid by companies at an affordable price, to be used by governments to provide medicine to poor countries.

Combined with the Orphan Drug Act, the voucher system would provide a powerful incentive to develop new treatments.

NGOs like Oxfam and Doctors Without Borders provide fantastic humanitarian aid to the third world. But when the World Health Assembly and other international bodies meet, officials should advance policies that have proven effective rather than radical political agendas that will help no one.

Anti-IP Special Interests Continue to Pursue Strategies at IGWG that Benefit Grey Market Suppliers and Others that Profit from Their Agenda

At the World Health Organization meetings, a myriad of special interest groups are aggressively lobbying member states to loosen the definition of counterfeit medicines and to weaken intellectual property protection. Three key strategies are at the heart of the Anti-IP activists tactics o benefit generic and “grey –market” suppliers of drugs.

The first strategy is to weaken the definition of counterfeit drugs. Recently BUKO, one of the organizations that belong to Health Action International, an anti intellectual property and an anti -health industry interest group, released a paper that, among other things, made the claim that “counterfeits may at times have advantages”. http://patientsandpatents.wordpress.com/2008/05/22/resolution-on-counterfeit-medicine/. During the current round of WHO meetings the leaders if knowledge Ecology International and Essential Action are working aggressively to water down the WHO’s definition of counterfeit medicines.

The second strategy is to encourage governments in developing countries to seize intellectual property through compulsory licenses, a mechanism that basically expropriates patent protection. This strategy is popular with some governments that profit from the sick by adding tariffs and mark- ups to drug purchases. However it has also lead to a proliferation of sub standard drug manufacturing to the extent that at least one African country resorted to withdrawing the operating licenses of dozens of generic manufacturers.

The third strategy is to convince the member states of WHO through recommendations of the Intergovernmental Working Group on IP and Public Health (IGWG) that somehow governments in developed countries can redirect precious health resources away from sustaining their own health systems in order to replace the billions of dollars in health research and development that are currently provided by health industries and pharmaceutical companies. A recent article by Helen Disney points out the folly of this approach:

Under Slovenia’s presidency of the EU, the Union has put the achievement of the Lisbon Agenda goals at the core of its activities. The use of market forces and incentives is held up as the most appropriate way to stimulate research and development, with strong intellectual property protection underpinning the innovation system. There thus appears to be a mismatch between the rhetoric being used in Geneva, as a result of the recent discussions of the inter-governmental working group, and the language of Brussels and Ljubljana. The question is: which direction does the EU really wish to choose?

The EU’s innovative performance currently falls well below that of the US and Japan. Europeans simply cannot afford the consequences of compromising the Lisbon Agenda goals for a state-led innovation system that will do little to help those in the developing world.

Indeed, it is the private sector that contributes the bulk of health-related research and development. Private pharmaceutical expenditure on research and development in Europe is estimated at €22.5 billion in 2006, outstripping by far the EU’s annual healthcare budget for the 7th framework programme for research of €850 million. In all likelihood, the private market will continue to be the major driver of research into new treatments, including for diseases that affect the world’s poor – but only if the right incentives exist.

Well-funded special interest groups no doubt attract many people who genuinely share the global concern for access to health in Africa and other developing regions. They also attract those that are well paid to pursue an agenda on behalf of undisclosed governments and corporations who can profit handsomely from the efforts of anti-IP activists.

Among those lobbying most aggressively is Knowledge Ecology International (KEI), an organization who according to public records has had its key employees very well paid by Essential Action, another Anti-IP lobby group.
 
KEI’s website acknowledges that it supplies “technical” support for governments and “firms” but provides no information on what firms and what governments are the beneficiaries of this “technical” advice or whether it collects fees or other considerations for these services.

The WHO, through IGWG, has an opportunity and a responsibility to develop a global strategy that can save millions of lives in the developing world. But it needs to be wary that this agenda actually improves the potential for medical innovation to meet the global health challenges we face and to ensure that this agenda is not hijacked by special interests who hide behind ideological rhetoric, who lobby for undisclosed firms and governments and who invest significant effort in trying to intimidate patient advocates and others who have a contrary view of how best to improve global health outcomes.

Overview of the IGWG draft plan

The WHO’s Intergovernmental Working Group on Public Health, Innovation and Intellectual Property will present their incomplete draft strategy at this week’s 61st World Health Assembly.

Unfortunately, unless you’re a lawyer or government policy analyst, it is difficult to understand what the real reccomendations are.  For everyone else, here is an easy to understand overview of the WHO IGWG draft plan.

Truth from the front lines

I had the pleasure of attending the Patients and Patents reception and workshop in Geneva on the eve of the 61st World Health Assembly where we received an update on the progress made by the IGWG on Public Health, Innovation and Intellectual Property.

One of the speakers was an Anglican priest from Nigeria, Father Ojeh.  Quoting Jesus, Father Ojeh said,”What I do, ye can do also”.  Anyone one of us, if we put our minds to it, could discover the next life-saving drug.  Yet, realistically, to do so we would require education, materials, assistance and the incentives to devote our lives to such a noble cause.   Father Ojeh went on to say that the real barriers to drug access in Nigeria was not patents, but politics and poverty.

Every life-saving drug we enjoy today was discovered in a system that provided incentives, the chief amongst which, is intellectual property protection.  No one will spend a life time dedicated to something only to have it stolen from them for ill-gotten profits the minute they achieve their life’s goal.  All this talk at IGWG by silk-stockinged socialists about compulsory licensing is nothing but self-serving bunk.

Thank-you Father Ojeh for your words of wisdom and for putting patients first in your congregation in Nigeria.  The WHA could learn from priests who serve the people of developing countries by putting patients first and not self-serving politicians, bureaucrats and NGO’s.