United Nations members this month are setting the future course for global action against a rising public health problem well-known in developed countries and spreading to developing countries: non-communicable diseases. But whether they will – or should – address concerns that intellectual property rights issues might interfere with access to treatments for such diseases as diabetes, cancer, or heart disease remains to be seen. [Update: UN members adopted the political declaration on NCDs this week without debate.]

The issue of non-communicable diseases – NCDs – has gained significant attention on the international stage in recent years with the acknowledgement by leading developing countries of the rise of such problems among their populations.

The World Health Organization highlights four disease areas under NCDs: cancer, cardiovascular diseases, chronic obstructive pulmonary disease, and diabetes. Factors attributed to these diseases include tobacco use, unhealthy diet, harmful use of alcohol, and physical inactivity.

But intensive negotiations over the past few weeks leading up to the grand-scale 19-20 September UN “high-level meeting on noncommunicable disease prevention and control” in New York have raised concerns that access to treatments for these diseases may be hindered by IP rights.

The General Assembly meeting is only the second ever to deal with health issues (the first was HIV/AIDs), and at least 34 heads of State and government, 50 other leading government ministers and many specialists are expected to attend, according to the UN.

Ala Alwan, assistant director general at the WHO, speaking to press today at the UN, highlighted three priority areas for the UN 193 member states to take: “surveillance and monitoring; reduction of risk factors such as harmful uses of tobacco and alcohol, unhealthy diets and lack of exercise; and a health-care component to tend to the millions already suffering from NCDs,” the UN said. This indicates a clear focus on preventative measures first, treatment second.

But public health advocates see a coming crisis in treatment and want measures now to address it. For instance, Health Action International issued a briefing paper [pdf] this week showing medicine prices are often too high for those on low wages, and urging the summit to “refocus on the attainable goal of universal access to essential medicines as a core priority for the treatment of NCDs.” This includes promoting access to affordable, quality generic medicines.

In general, the issue of NCDs have motivated the public health community in Geneva and elsewhere (IPW, Public Health, 7 July 2011).

Secret Negotiations

Closed-door negotiations in New York have focussed on a draft declaration for ministers at the summit. Information about the negotiations has not been public, the draft declaration was confidential even a few days before the summit gathering to approve it, and inquiries to UN press officers went unanswered. But sources say that a key element of debate has been whether to include references in the declaration related to the World Trade Organization Agreement on Trade-Related Aspects of Intellectual Property Rights (TRIPS).

In particular, focus seems to be on inclusion of a reference to the 2001 Doha Declaration on TRIPS and Public Health, which accentuates the right of countries to use flexibilities in IP law as they see fit.

The draft declaration is available here [pdf].

How much intellectual property rights should be a part of policy debates over NCDs is a matter of disagreement. Non-governmental groups are concerned that patents – which typically lead to higher prices by granting a monopoly – will put medicines for NCDs out of reach of poor populations. The rights-holding industry says the fear is overblown, as most existing medicines for NCDs are already off patent, and offered in cheap generic form.

But NGOs counter that this may be the case for existing drugs but would not be the case for future ones, which will presumably be patented as they are developed. An industry source replied to this by saying that while communicable diseases can develop resistance to medicines, NCDs do not, so existing medicines should remain effective. The only concern could be about better, more effective medicines that might come along in the future.

TRIPS was reportedly raised during the recent weeks’ negotiations by some of the Group of 77 developing countries who were concerned that flexibilities for developing countries embedded in those IP trade rules be applicable to this comparatively new area of public health. The tough negotiations ran over time, according to some sources, but in the end it was apparently agreed to strike the reference to the Doha Declaration on TRIPS and Public Health, as sought by developed countries.

According to sources, concerns were raised during the negotiations that the US and European Union were leading an effort to prevent TRIPS flexibilities from applying to NCDs, among other actions that would weaken the declaration on behalf of affected industries. Representatives of several agencies of the US government who are on the US delegation did not answer press requests for confirmation on this point.

One nongovernmental source said an argument was made that the Doha Declaration does not apply to NCDs. The argument may have been that flexibilities, like compulsory licences that allow the production of inexpensive versions of patented medicines without permission from the patent holder, are only allowable in cases of emergency or epidemic – which NCDs are not.

Several years ago, Thailand met with intense industry and developed country pressure when it took the step to issue a compulsory licence on a heart disease drug (IPW, Public Health, 16 February 2007). But US trade officials at the time said Thailand was apparently not in violation of TRIPS rules, and NGOs note that developed countries take compulsory licences for non-emergency matters all the time.

TRIPS In and Out of Draft Text

The latest draft of the declaration contains compromise text for paragraphs 34h and 48bis of the draft declaration which references TRIPS flexibilities, but dropped any mention of the Doha Declaration. The relevant portions of these paragraphs currently read:

“34h: Promote access to comprehensive and cost-effective prevention, treatment and care for the integrated management of NCDs, including, inter alia, increased access to affordable, safe, effective and quality medicines and diagnostics and other technologies, including through the full use of TRIPS flexibilities.

48bis: Urge relevant international organizations to continue to provide technical assistance and capacity building to developing countries, especially to the least developed countries, in the areas of NCD prevention and control and promotion of access to medicines for all, including through the full use of TRIPS flexibilities and provisions.”

These paragraphs previously included references to TRIPS flexibilities and the Doha Declaration, according to sources. Opponents of inclusion of the Doha Declaration may have viewed it as expanding the agreement to new areas, which they wanted to prevent because it could lead to lower prices for treatments produced by their private sectors. The Doha Declaration contains a reference to “other epidemics”, so theoretically removing reference to epidemics or the Doha Declaration would remove its applicability.

Knowledge Ecology International and others NGOs and academics interpret the omission of specific reference to the TRIPS and Public Health declaration as an attempt to make it possibly not applicable to NCDs. In this way, they argue, northern economies, and the Obama administration in particular, are undermining an agreement made by the predecessor Bush administration. KEI has a website section dedicated to the NCD negotiations.

Brook Baker, a Northeastern University (US) law professor, said the concern by the US and EU is that the UN efforts will lead to NCDs being considered an emergency. And developed countries interpret TRIPS as allowing use of compulsory licences and other flexibilities in cases of emergency. The northern countries housing most of the brand-name drug producers are opposed in order “to reduce the risk that countries might consider NCDs ‘emergencies or matters of extreme urgency’ that do not require prior negotiations for voluntary licenses on reasonable terms before issuance of compulsory licenses under Art. 31 of the TRIPS Agreement,” Baker said today on the KEI ip-health listserv. Instead, they have their eyes on those markets as NCDs continue to rise, he charged.

The draft declaration still refers to NCDs as “epidemic.”

Also in the text, another non-agreed paragraph discusses the importance of access to diagnostics and medicines, including help with financing of affordable products including generics, sources said.

And another paragraph in the draft declaration on access to medicines also appears to be not agreed: “33.d. Contribute to efforts to improve access and affordability for medicines and technologies in the prevention and control of non-communicable diseases. [Chair’s Text]”

Other references in the declaration include the impact on NCDs of food security problems, climate change and increasing loss of biodiversity, and a call for increased access to “cost-effective” vaccinations. There is also a reference to the importance of respecting, preserving and promoting traditional knowledge and medicines – but with the usual legal catchword: “as appropriate.” The next paragraph emphasises that efforts related to traditional knowledge be governed at the national level. Developed countries have resisted binding legal language at the international level in regards to this, while local communities in developing countries complain about a lack of international protection against theft of their traditional practices and resources.

Industry: Focus on Prevention, Not IP

Andrew Jenner, director of innovation, intellectual property and trade at the International Federation of Pharmaceutical Manufacturers and Associations (IFPMA) in Geneva, called the TRIPS reference issue “a red herring,” and said that “TRIPS flexibilities apply regardless” of whether there is mention or not.

Industry is concerned that policy debates will become overly focussed on the IP issues as they have done in recent years with infectious diseases (such as HIV/AIDS), which could undermine effective policymaking against NCDs, he said. “We don’t want the TRIPS discussion to hijack the discussion,” Jenner told Intellectual Property Watch.

IP issues are not the same with NCDs, he said, because of the availability of generics. “There are many generic alternatives available but many patients are not getting access in developing countries,” he said. What’s more important at this stage is to ensure effective diagnosis and delivery.

In general, flexibilities were not intended to be the first step, Jenner said, calling flexibilities “a blunt tool in the box.” There are other steps that can be tried first, he said, such as discussing needs with rights holders, tiered pricing for different markets, or going through international agencies.

Pharmaceutical industry representatives say the upcoming summit in New York will be a high-level opportunity to begin focussing on the challenge as it faces developing countries, with the first priority being on prevention. The first focus of policymakers should be on prevention of NCDs, said Mario Ottiglio, associate director for public affairs & global health policy at IFPMA. Healthy diet and exercise can have a drastic impact on NCDs, he said. IFPMA launched a “framework” for prevention in June, and in August launched a consultation on the framework.

“Developing countries are under a double burden,” Ottiglio told Intellectual Property Watch. They already face problems with infectious diseases, and now have the problems that the rise in NCDs in many developing countries is bringing to the healthcare system. Better use of resources for health literacy could lead to a more efficient use of funds.

In addition, the summit is a “great opportunity for new partnerships between stakeholders that may otherwise never have met,” he said. For instance, IFPMA is working with the World Health Professionals Alliance, carrying out a program to help patients measure their health status. IFPMA also is working with the Red Cross Red Crescent Society.

Separately, in the rules for the summit, member states were encouraged to consider including in their national delegations elected officials, and civil society – including NGOs, academia and “networks working on the control and prevention of non-communicable diseases.” It is unclear the extent to which governments have heeded this suggestion.

Seeking a Strong Declaration for the Public

Universities Allied for Essential Medicines and other nongovernmental organisations issued a release on 1 September, the day before negotiations ended, raising concern about the watering down of the declaration by the richer countries seeking trade and economic advantages, such as for tobacco and snack food industries. They singled out the United States, European Union, Canada, and Japan.

“Alarmed by explicit efforts led by developed countries to weaken the Declaration’s language in a way that will undermine effective prevention and treatment of NCDs, over 70 public health NGOs and groups representing hundreds, if not thousands, of people living with HIV/AIDS from across the globe are now sounding the alarm,” it said. AIDS activists say they had a tough fight to achieve better access for poor populations to high-priced patented drugs, and do not want to see the same difficult path to access to NCD-related drugs.

WHO Report

Separately, the WHO this week launched its WHO Noncommunicable Diseases Country Profiles 2011, a report with new information about the situation in 193 countries. According to WHO, the report details the proportion of each country’s deaths due to diseases such as cancer, heart and lung diseases, and diabetes. It also looks at trends in metabolic risk factors (cholesterol, blood pressure, body mass index and blood sugar) and countries’ capacities to address the challenges of NCDs. The report was to be presented at a 12 September press conference by Douglas Bettcher, director for Tobacco Free Initiative, and Leanne Riley, team leader surveillance in the WHO Department of Chronic Diseases and Health Promotion.