The Importance of a Global Patent Database for Pharmaceuticals

The World Health Organizations’s Intergovernmental Working Group on Public Health, Innovation and Intellectual Property (IGWG) is considering at the 2008 World Health Assembly a proposal to create a user-friendly, public, global database on the status of health-related patents in all countries.

Essential Action urges adoption of this proposal, which could meaningfully advance public health objectives, including efficient pharmaceutical procurement, in developing countries.

A summary of our briefing note, and the full text, follow on the continuation of this post.

ESSENTIAL ACTION BRIEFING NOTE FOR WHA IGWG:
THE IMPORTANCE OF A GLOBAL PATENT DATABASE FOR PHARMACEUTICALS

Full text available below in html and here as an rtf document: PatentDatabaseMay18.rtf

Executive Summary:

A proposal before the WHO’s Intergovernmental Working Group on Public Health, Innovation and Intellectual Property (IGWG) at the 2008 World Health Assembly is to “[to compile, maintain and update user friendly global databases on the status of health-related patents in all countries and facilitate widespread access to the databases, in particular by developing countries and to strengthen national capacities of analysis and the quality of patents.] “[1]

Adoption and implementation of such a global patent database on health-related inventions would advance important public health objectives, including the promotion of innovation, and facilitating access to medicines in developing countries. Although there are technical challenges in compiling such a database, these can be overcome. As a policy matter, it is very hard to imagine a legitimate basis for opposing such a proposal.

Essential Action has worked with numerous national patent offices in developing countries to investigate the patent status of important medicines, and it is frequently the case that the patent offices cannot identify patents related to particular products, or can only do so with enormous difficulty. Patent and registration information is important for a variety of reasons. Examples include:

– Government agencies, NGOs or others cannot make determinations about efficient procurement options if they cannot ascertain patent status; and inadequate information on patent status has in some cases interfered with efficient procurement of HIV/AIDS medicines.

– Generic firms are unable to determine when they can enter the market (whether they have “freedom to operate”) if they do not know whether products are patented.

– Researchers may be inhibited from investigating certain areas if they cannot identify whether patents cover information in their field of inquiry. [2]

***Essential Action recommends that WHO member countries agree to the proposed – and currently bracketed – language in Element 5.1(c) of the 3 May 2008 White paper of the IGWG Draft global strategy, which proposes a user-friendly global patent database be compiled, maintained and updated to contribute to innovation and promote public health.***

References:
[1] See Element 5.1 (c), World Health Organization (WHO), “The White Paper (Advance copy in English only) of the IGWG “Outcome Document at 14.00 hours, Saturday 3 May 2008, Draft global strategy on public health, innovation and intellectual property,” available at, http://www.who.int/phi/documents/IGWG_Outcome_document03Maypm.pdf

[2]Professor Frederick Abbott, Florida State University College of Law, “Patent Landscaping in the Field of Medicines: Policy and Technical Options,” World Intellectual Property Organization (WIPO) Symposium on Public Policy Patent Landscaping in the Life Sciences: Provisional Program, April 8, 2008, available at: .

———
For More Information, Contact:

Sarah Rimmington, (Geneva, week of May 29, 2008) +41 (0)78 847 0562, [email protected]

Robert Weissman, (Washington, DC) (+1) 202-387-8030, [email protected]

Essential Action
PO Box 19405, Washington, DC USA 20036
www.essentialaction.org/access

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Full text of the briefing note:

Essential Action
P.O. Box 19405, Washington, DC 20036, USA
Tel: 1-202-387-8030 • Fax: 1-202-234-5176 www.essentialaction.org/access

BRIEFING NOTE FOR WHO IGWG

THE IMPORTANCE OF A
GLOBAL PATENT DATABASE FOR PHARMACEUTICALS

A proposal before the WHO’s Intergovernmental Working Group on Public Health, Innovation and Intellectual Property at the 2008 World Health Assembly is to “[to compile, maintain and update user friendly global databases on the status of health-related patents in all countries and facilitate widespread access to the databases, in particular by developing countries and to strengthen national capacities of analysis and the quality of patents.] ”

Adoption and implementation of such a global patent database on health-related inventions would advance important public health objectives. Although there are technical challenges in compiling such a database, these can be overcome. As a policy matter, it is very hard to imagine a legitimate basis for opposing such a proposal.

Disclosure is Central to the Patent System
The patent system is supposed to be one of disclosure. Not only is the basic fact of a patent claim supposed to be public knowledge, but the very provision of a patent is supposed to embody a trade-off whereby the means to make the underlying invention is publicized in exchange for grant of the patent monopoly.

Patent Information for Pharmaceuticals is Commonly Not Available in Developing Countries
There are significant obstacles to identifying the patent status of any particular product even in rich countries. There are many patents filed on most pharmaceutical products, and very complicated patent landscapes for health products such as vaccines. Patent applications may be easily searchable, but the patent applications typically do not reference end products — in significant part because they are filed before end products are even known. Patents on medical products also commonly involve very technical claims that are comprehensible only to persons with substantial scientific training.

These obstacles can typically be overcome in rich countries, however, by one of two First, commercial services are available to do patent searches. Such services are often very expensive, but can develop the patent landscape of a product. Second, in countries such as the United States, pharmaceutical registration systems may involve listing of patents for most pharmaceutical products. These listing mechanisms may, as in the U.S. case, harmfully delay introduction of generic competition (by denying generic firms the right to register a product if a patent is claimed to cover it — an arrangement known as “linkage,” because it links registration to patent status), but they do make patent information publicly available for covered products.

In many developing countries, however, neither of these options is available, and pharmaceutical patent information is effectively secret from all but the patent holder. Commercial services may not exist, or may be prohibitively expensive for public health agencies and organizations. And patent registries commonly are not available.

Essential Action has worked with numerous national patent offices to investigate the patent status of important medicines, and it is frequently the case that the patent offices cannot identify patents related to particular products, or can only do so with enormous difficulty.

Coordinated Global Efforts Can Identify Patents
Several patent mapping efforts have demonstrated that, with sufficient time and expertise, and modest resourcing, the barriers to identifying patents in developing countries can be overcome.

Medecins Sans Frontieres, in conjunction with UNAIDS and WHO, has developed patent landscapes for HIV/AIDS medicines in many developing countries. Additionally, WHO has conducted a recent pilot program to identify patents on essential medicines. Even if unable to identify all patents in all circumstances, these efforts have been successful, and show that development of a global patent database is feasible. These efforts also have pioneered the appropriate methodologies to identify patent landscapes in developing countries. Although this information must be obtained at the national level, preliminary work — with global application — must be done in rich country patent offices. There are thus built-in economies of scale to undertaking global — rather than only country-by-country — patent searches.

An established system for maintaining and elaborating a global patent database would also be well positioned to facilitate voluntary information sharing from patent-holding pharmaceutical companies. This would dramatically ease the burden of patent searches.

The Importance of Patent Disclosure
Patent and registration information is important for a variety of reasons. Government agencies, NGOs or others cannot make determinations about efficient procurement options if they cannot ascertain patent status; and inadequate information on patent status has in some cases interfered with efficient procurement of HIV/AIDS medicines. Generic firms are unable to determine when they can enter the market (whether they have “freedom to operate”) if they do not know whether products are patented. Researchers may be inhibited from investigating certain areas if they cannot identify whether patents cover information in their field of inquiry.

The case of avian flu vividly illustrates the importance of patent disclosure and the need for a global patent database. With a peak of concern over avian flu in late 2005, countries paid special attention to stockpiling the anti-viral oseltamivir (brand name Tamiflu), in advance of a possible outbreak of avian flu among humans. Because of the shortfall of supply, plus price concerns, many countries were eager to obtain generic versions of oseltamivir. But there was considerable uncertainty in many developing countries about the patent status of oseltamivir. Countries did not know if they were free to purchase or manufacture generic versions of the drug, or if they must obtain licenses — voluntary or compulsory — in order to legally purchase or manufacture generic versions. Many countries were slow to seek generic versions of the product because of the misapprehension that it was patented in their country. Some even began the process of issuing compulsory licenses — until the manufacturer, Roche, finally informed them that there were no patents covering the drug in their countries. To be clear: even the governments themselves were unaware of, and not easily able to determine, patent status of the drug in their countries.

Patent information is not a trade secret. Patents are conferred by governments in exchange for disclosures of the underlying inventions. The purpose of the system is defeated — and public health objectives potentially seriously undermined — when the very fact of whether a product is covered by a patent (and which patents) is not public. A global patent database covering health-related inventions would cure this problem.

May 2008
———
For More Information, Contact:

Sarah Rimmington, (Geneva, week of May 29, 2008) +41 (0)78 847 0562 [email protected]

Robert Weissman, (Washington, DC) (+1) 202-387-8030, [email protected]

Essential Action
PO Box 19405, Washington, DC USA 20036
www.essentialaction.org/access

WHO: Tough negotiations on IP and health to continue at WHA

by Sangeeta Shashikant
Published in South-North Development Monitor (SUNS) #6475

Geneva, 15 May (Sangeeta Shashikant) — The gruelling negotiations over the Draft Global Strategy (GS) on public health, innovation and intellectual property that took place a fortnight ago at the Inter-governmental Working Group on Intellectual Property, Innovation and Public Health (IGWG) are expected to continue next week at the World Health Assembly.

According to a WHO official, there is a move to set up a drafting group on the first day of the Assembly that begins on 19 May. The drafting group is to try to resolve deep differences among the member states in 16 places in the text that are within brackets on the Draft GS. The mandate of the IGWG has come to an end, and the WHA is now expected to take over the process.

The IGWG was set up following Resolution WHA59.24 (adopted in May 2006) and was tasked with drawing up a global strategy and plan of action (POA) to provide a medium-term framework based on the recommendations of the Commission on Public Health, Innovation and IP (CIPIH).

Its main aim is to secure an enhanced and sustainable basis for needs-driven, essential health research and evelopment relevant to diseases that disproportionately affect developing countries, and to propose clear objectives and priorities for research and development, and estimating funding needs in this area.
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The IGWG was to submit the final GS and POA to this year’s 61st WHA, but these two documents are not yet ready. The Working Group and a Sub-Working Group have met a total of 4 times – in December 2006 (First Session of IGWG), November 2007 (Second Session of IGWG), March 2007 (meeting of sub-group of IGWG); and 28 April-3 May (Resumed Second session of IGWG).

Sources also indicate that some delegations may put forward a draft resolution for the WHA to adopt the Global Strategy (if it is finalized during the WHA) and to outline the way forward.

There is also likely to be a push for early implementation of some items in the Global Strategy as part of the draft Resolution. This may cause significant debate.

Negotiations on the issues within the 16 brackets of the GS will doubtless be a major challenge for delegations from developing countries, in light of the recent IGWG meeting which was characterized by the inflexible attitudes of developed countries, particularly the United States and Japan.

It is not clear what will be the way forward if there is no agreement on the GS. According to some sources, if there are paragraphs on which there is consensus except for the US, there could be a situation similar to that at the last WHA, with regards WHA Resolution 60.30 on taking forward the work of the IGWG. Despite strong objections by the US, this resolution was eventually adopted as it enjoyed the support of all other delegations.

Out of the 16 remaining bracketed text, five have the status of enjoying consensus but pending approval from the US.

There is also much work to be done to finalize the Draft POA that emerged from the last negotiations. The Draft of 3 May 2008 with the heading “Chair’s text” contains text on stakeholders and time-frames discussed by the drafting group; there is consensus on only some parts of this.

According to sources, some parts of the Draft POA, such as the role of lead stakeholders for the specific actions agreed in the Strategy, may also be discussed during the WHA. It may be proposed that other parts of the Draft POA – such as the progress indicators which were discussed at the sub-group meeting that took place prior to the IGWG’s May meeting – should be developed by the Secretariat after the WHA.

Also, an estimation of the funding needed to implement the Strategy and POA has yet to be done. It may be proposed that the Secretariat undertake the costing after the WHA. It is expected that the Draft POA and the funding estimates will be presented at the WHO’s Executive Board meeting in January 2009.

The WHA will have to deal with bracketed texts in the GS, which are in the following parts of the draft: the “context”, the “aim”; the “principles”, “transfer of technology”; “application and management of intellectual property to contribute to innovation and promote public health” and “improving delivery and access”. The last two sections have the most bracketed text.

Delegates from developing countries expect a tough battle, given their experience at the last IGWG meeting where developed countries, particularly the US and Japan, showed no or little inclination to accommodate the developing countries’ interests on the issues that really matter.

Several developing country negotiators felt that these developed countries came to the IGWG meeting with nothing to offer, and their aim was simply to delete text proposed or supported by developing countries, or else to dilute some text through use of terms such as “where appropriate”, “voluntary”, “where possible”. In some cases, the developed countries succeeded in injecting these terms several times in one sentence.

During the negotiations, 5 of the 16 bracketed paragraphs achieved the status of “consensus but pending approval by the US.” Two other paragraphs have consensus but pending approval from Suriname (for one) and Ecuador (for the other).

Several developing country delegates as well as public-interest NGOs felt that there was little desire on the part of developed countries such as Switzerland, EU, US and Japan to make concrete commitments in the GS and POA despite an urgent call in the CIPIH report and public health groups to think differently and to take immediate concrete action to resolve health problems of developing countries with regard to innovation and access.

James Love from Knowledge Ecology International, based in Washington, said that “the EU and US were basically in a mode to defend the status quo and to keep their pharmaceutical industry lobbyists at bay. There were no profiles of courage among the high income country delegates.”

Ethan Guillen, Executive Director of Universities Allied for Essential Medicines said “the fact that there had to be stiff negotiations on the idea that the cost of medicines impedes access in the developing world makes you wonder if some negotiators hadn’t noticed that busloads of American retirees have to hop across the US border to Canada to get drugs they can afford. New incentive mechanisms are obviously necessary to promote R&D for medicines that don’t have a market in the developed world.”

Sarah Rimmington from Essential Action was of the view that urgently needed new incentive mechanisms were not agreed to because of resistance from developed countries. She added: “Significant time was lost debating core principles such as the role of patents in creating barriers to access to medicines, and the importance of promoting the use of already-agreed to flexibilities under international trade law to promote access to affordable generic medicines where patent protections remain a problem.

“It is hard not to wonder if pressure from the brand-name pharmaceutical industry – which is based in developed countries and remains ideologically committed to patent monopolies – influenced this disappointing outcome.”

However, despite the obstacles, developing countries such as Brazil, India, Suriname, Thailand, Bolivia, Barbados and Africa Group, determinedly pushed forward. The result is that a heavily bracketed draft presented at the start of the IGWG meeting is now reduced to 16 areas.

The bracketed paragraphs in the part on application and management of IP include language on:

(1) the creation of user friendly global databases on the status of health related patents [para 5.1 ( c)];

(2) countries avoiding the incorporation of TRIPS-plus measures in any trade agreements and in national legislation that negatively impact on access to health products [para 5.2 (b)];

(3) assessing the impact of data exclusivity on access to medicines [para 5.3 (b)];

(4) adopting and/or effectively implementing competition policies in order to prevent or correct anti-competitive practices related to health products; [para 5.3 ( c)];

(5) consider developing guidelines for patent examiners on how properly to apply patentability criteria in a way that promotes high quality patents and a public health perspective [para 5.3 (d)];

(6) avoiding restrictions for the use of or reliance on undisclosed test data in ways that would exclude fair competition or impede the use of flexibilities built into TRIPS [para 5.3(e)].

Some developed countries objected to paragraphs (2), (4), (5) and (6) above although they reflect recommendations of the CIPIH report and in some cases even what is being practised in developed countries.

According to some sources, several developed countries and in particular the US would like to dilute the mandate of WHO in the area of IP and public health and to restrict the mandate on public health related technical assistance to the WTO and WIPO, which have a more commercial orientation.

There is a real risk that the bracketed language in this section will be further diluted or deleted during the upcoming WHA as the alternative option to paragraphs (2), (3), (5) and (6) is to delete the bracketed paragraphs, said the sources.

In the section on improving delivery and access, bracketed paragraphs include language on:

(1) developing and strengthening, where appropriate, legislative, regulatory oversight mechanisms and other measures to minimize the risks to public health resulting from the [production, trafficking and] use of drugs which have been counterfeited, adulterated, [have expired or are substandard, including by prohibiting the production and trafficking of counterfeit and substandard products]/[ have expired, through health promotion, surveillance and health regulation. [para 6.2 (e)];

(2) encourage pharmaceutical companies to continue or to adopt pricing policies, including differential pricing policies, that are conducive to promoting access to quality, safe, efficacious and affordable health products in developing countries, consistent with national law [para 6.3(d)];

(3) stimulate the development of policies to monitor pricing to improve affordability of health products and strengthen WHO’s ongoing work on pharmaceutical pricing [para 6.3 (e)].

On para (1) above, a main issue is the definition of “counterfeit”. To date, no official definition has been adopted by Member States although there are 2 different definitions being used by WHO.

Another issue is what is the appropriate scope that should be a part of the GS. Some developing countries argue that the main problem is substandard products, which relates to strengthening regulatory capacity, an element that is already mentioned in the GS and so the language in (1) above should be deleted. However, developed countries, and some other developing (e. g. Africa Group) would like to see language on counterfeit products.

On paragraphs (2) and (3), there is consensus but pending approval from the US.

Other parts that have bracketed texts are “the context”, “the aim”, “the principles” and “transfer of technology”.

Under the part on “context”, 2 paragraphs and a footnote are bracketed. One of the paragraphs is “Proposals should be developed for health-needs driven research and development that include a range of incentive mechanisms, including also addressing the linkage between the cost of research and development and the price of medicines, vaccines, diagnostic kits and other health-care products and a method for tailoring the optimal mix of incentives to a particular condition or product with the objective of addressing diseases that disproportionately affect developing countries.” [para 4]

This paragraph (which is in brackets, pending US approval) reflects language in Resolution 60.30 (on advancing the IGWG’s work) adopted by the WHA last year. The US vehemently objected to this language then, but it was unable to frustrate the eventual adoption of this Resolution.

In the part on principles, bracketed text is in the following two areas:

(1) “The WHO Constitution states that “the objective of WHO shall be the attainment by all peoples of the highest possible level of health”. Accordingly, WHO shall play a strategic and pro-active role in contributing to pursue the agenda on “public health, innovation and intellectual property”, within its mandate and its constitutional objectives. To achieve this, WHO, including the regional and country offices, shall strengthen institutional competencies and programmes to implement this strategy and plan of action as well as the existing mandates given by relevant WHA resolutions.” [para 15]

(2) “The objectives of public health and the interests of trade should be appropriately coordinated and mutually supportive/balanced and coordinated” or “The right to health takes precedence over commercial interests.” [para 18]

Some key developing countries see immense value in having para (1) as part of the Strategy as it speaks of WHO playing a more “strategic and pro-active role” in relation to public health innovation and IP.

Presently, all except for the US have agreed to the text although some sources indicate that other developed countries may want to reopen the text. However, this is unlikely to be acceptable to most countries.

Under the part on “aims”, what remains in brackets is a footnote which refers to Type I, II and III diseases, and mentions the “specific diseases” on which the draft strategy will focus.

These specific diseases are Type I diseases which are increasingly prevalence in developing countries, for example, diabetes, cardiovascular diseases and cancer; Type II diseases where a substantial proportion of the cases are in poor countries (mentioning a focus on HIV/AIDS and TB); and Type III diseases which are overwhelmingly or exclusively incident in developing countries (mentioning a focus on chagas disease, dengue and dengue haemorrhagic fever, leishmaniasis, leprosy, lymphatic filariasis, malaria, onchocerciasis, schistosomiasis and human African trypanosomiasis. The footnote adds that “nevertheless, Member States can either expand or narrow the list of diseases as appropriate.”

The specifying of diseases under each of the types of is opposed by many developing countries. They believe that the listing would limit the overall application of the GS & POA and it would also prejudge the outcome of one of the agreed aims of the GS, i. e. to provide an assessment of the public health needs of developing countries and identifying R&D priorities at the national, regional and international levels.

Several NGOs also oppose such a listing of diseases. They recall that there was a strong push by developed countries to limit the scope of the Doha Declaration on TRIPS and Public Health and the related 30th August Decision in WTO, by specifying that these relate only to a limited list of diseases. This attempt failed and the Doha Declaration and the 30 August Decision do not limit the scope of diseases. The NGOs also do not want the scope of the GS to be limited by a list.

Under transfer of technology, there is agreement except for the US on language to “promote transfer of technology and production of health products in developing countries through investment and capacity building including by providing guidance on appropriate technologies”.

This is a compromise text, as developing countries also originally advocated establishing a “reference list of echnologies”, but this was simply unacceptable to developed countries. +

Keep prices down – Times of India op-ed

Times Of India

Keep prices down
By Robert Weissman
8 May 2008

WASHINGTON: In a recent opinion piece (‘In defence of patents‘, Apr 28), Tim Wilson implies that patent monopolies do not drive up drug prices. He misstates international patent rules. And he equates patents with innovation, confusing a means with an end.

Wilson suggests that public health advocates’ concerns that patents “increase the cost of medicines for the world’s poor” is misplaced. This is a strange argument. Patents confer marketing monopolies and are intended to enable patent holders to raise prices. This the brand-name drug companies do quite well.

India has enjoyed among the lowest prices for medicines in the world, precisely because the country has not, until recently, adopted product patent rules. On a global basis, the case of HIV/AIDS drugs is illustrative of the impact of patent mono-polies, but not exceptional. Less than 10 years ago, the price of HIV/AIDS medicines in most of the developing world was $10,000 a year per person, or more. Today, thanks to generic competition, the price is as low as less than $100 a year. Before the price reductions, an HIV/AIDS diagnosis was a death sentence in the developing world. Now three million people in developing countries are receiving life-saving treatment.

Wilson condemns Thailand for issuing compulsory licences for a heart disease drug (as well as for cancer and HIV/AIDS drugs). He untruthfully says this move abused world trade rules, claiming compulsory licences may only be issued in cases of emergency. The World Trade Organisation says that belief that an emergency is required for a compulsory licence “is a common misunderstanding”. In fact, the WTO says, “countries are free to determine the grounds for granting compulsory licences”.

Thailand’s action is a model for the world. The generic version of the heart-disease drug Thailand compulsorily licensed is 1/70th the cost of the brand-name product, enabling the government to offer the drug in the public health system. Previously, it was unavailable. Other countries, including India, should follow Thailand’s example.

Wilson also bemoans ongoing negotiations at the World Health Organisation (WHO), designed to identify means both to develop medicines that meet priority health needs in developing countries and to make those products available on an affordable basis. Underlying the WHO talks is a recognition that patents are only one mechanism to promote research and development and one that is not working for developing countries. Patents are not worth much if they offer monopolies on sales to a population that has little buying power.

Developing countries comprise 80 per cent of the world’s population but amount to only 13 per cent of the global market for medical products. As a result, there is little corporate sector R&D devoted to the needs of developing countries. A review by Doctors Without Borders of new drugs introduced between 1975 and 2004 found that of 1,556 new drugs put on the market, only 21 were for “neglected diseases” – diseases endemic to developing countries.

The WHO negotiations are looking at an array of innovative proposals to generate more R&D; direct R&D to respond to health needs, not just market demand; and ensure that new medicines and health technologies are accessible to people regardless of wealth. Wilson has every right to oppose such laudable objectives if he desires. But he should not mislead readers with distorted descriptions of policy debates about medical innovation and pharmaceutical affordability.

Those who prioritise the narrow commercial interests of big pharma over public health objectives have reason to defend a patent monopoly-based R&D system that is not working for the developing world. For everyone else, the rising interest in new institutional arrangements to promote the complementary public health objectives of innovation and access is something to embrace. The robust debate at the WHO – and the experimentation of many developing countries, including India – with diverse mechanisms to promote R&D offers the prospect of dramatic public health benefits in the years ahead.

The writer is director of Essential Action, a public health advocacy group.

This op-ed responds to a previously published op-ed by Tim Wilson. Here is the text of that piece:

Times of India
In defence of patents
Tim Wilson
28 Apr 2008

Intellectual Property (IP) has always been a niche public policy area understood best by policy wonks and lawyers. Unless there is a major controversy, IP tends to escape public consciousness. But that is changing. Over the past few years campaigns to undermine IP have increased and are now reaching a fever pitch.

IP is essential because it provides the property rights needed for research and development to attract investment with the prospect of a long-term dividend. Undermining IP is equivalent to the traditional socialist ethos — divvy the spoils of today’s research and development, rather than focusing on expanding it. And a lot is at stake — according to the most recent figures from the United Nations, the Indian patent registry receives more than 90,000 applications for patentable inven-tions each year. In spite of this significant contribution, there has been a global campaign to undermine IP rights by a group of anti-market activists, self-interested politicians, vested interests, and more recently, the infiltrated World Health Organisation (WHO).

Innovative medicines have been one of the big targets. These activists have argued that IP rights increase the cost of medicines for the world’s poor. Yet they ignore that one of the biggest contributors to increasing costs is actually government-imposed taxes and tariffs that raise the price of life-saving medicines. For instance, in India the combined taxes and tariffs on imported medicines are 55 per cent; in China, they are 28 per cent.

But this reality has not stopped govern-ments acting to undermine IP. In early 2007, the then Thai military government waived the patents of three patented medicines through a process called “compulsory licensing”. Compulsory licensing is an instrument recognised under the World Trade Organisation’s Trade-Related Aspects of Intellectual Property Rights (TRIPS) Agreement, and grants governments the ability to licence the production of patented products “in the case of a national emergency or other circumstances of extreme urgency or in cases of public non-commercial use”.

Now the WHO has waded into the debate. Last year, a WHO-designated team assessed the Junta’s actions and later issued a brief report legitimising the government’s actions, which was followed by a how-to guide for countries to waive their international obligations and issue compulsory licences.

This report is feeding into a WHO-initiated Intergovernmental Working Group (IGWG) on Public Health, Innovation and IP formed in 2006. From its inception the IGWG has been an attempt for health bureaucrats and the activists that advise them to rewrite — and under-mine — global IP rules. The activists are now using their campaign against IP on medicines as a precedent to continue their assault on IP; and global warming has become the new battleground.

In a joint statement at the 2007 G8 summit, the governments of Brazil, China, India, Mexico and South Africa called for an agreement to assist in compulsory licensing the IP related to carbon dioxide emission-mitigating technology being developed in wealthy countries.

In subsequent media reports the officials argued an agreement is needed “paralleling the successful agreement on compulsory licensing of pharmaceuticals”. Similar themes appeared in a resolution passed by the European Parliament in November last year recommending a study to assess amending TRIPS “to allow for the compulsory licensing of environmentally necessary technologies”.

And the tragedy is that those who are likely to suffer most are the world’s poor. Technology transfer is also vital for developing countries to grow their economies and improve their standards of health and the environment. A 2006 World Bank study and a 1998 Inter-national Energy Agency/UNEP study have identified that strengthening IP rights assists in technology transfer.

The World Intellectual Property Organisation has designated 2008 as the year for “celebrating innovation and promoting respect for IP”. With the IGWG convening in Geneva in a few days’ time and the assault on IP on climate-friendly technologies, World IP Day — which was on Saturday — increasingly seems to be an occasion to reflect on IP’s demise.

The writer is director of the IP and Free Trade Unit at the Institute of Public Affairs in Melbourne.

Daily Times (Malawi) Op-Ed: Response to Pharma-Connected Think Tank

The Daily Times (Malawi)

My Point of View -On neo-colonialist NGOs
By Robert Weissman,
07 May 2008

It would be easy to dismiss Temba Nolutshungu’s recent opinion — Neo-colonialist NGOs published in The Daily Times — if it were not part of an organised effort to spread confusion about vitally important policy debates with life-and-death consequences.

The author spins a fantasy story in which public health groups have wrested control of the World Health Organisation (WHO), and are seeking to undermine the efficient patent-based pharmaceutical research and development (R&D) system.

Perhaps readers might have been able to better understand the motivations for the author’s arguments if he had revealed his organisation’s financial entanglements with Big Pharma.

The author suggests that Africa has little reason to care about the price of medicines, because healthcare infrastructure is inadequate.

It is of course true that Africa’s healthcare systems are badly depleted and in need of massive investment. It is also the case that many of the public health advocacy groups that the author denounces are working to strengthen African healthcare systems.

But it is not a matter of choosing between improving healthcare systems and finding ways to lower the price of medicines so they are affordable.

Both are necessary, and both can be achieved.

Remarkably, the author highlights the case of HIV/Aids drugs. Ten years ago, before generic competition, brand-name companies charged roughly the same price for lifesaving HIV/Aids drugs in Africa as they did in rich countries — $10,000 a year per person, or more. An HIV diagnosis was a death sentence. Today, the price is as low as $100 per person — a price decline that leveraged a huge increase in donor money that otherwise would not have been made available. The severe problems with healthcare infrastructure notwithstanding, 2 million people living with HIV/Aids in Africa are today receiving treatment.

Much more needs to be done — and improving infrastructure is a top priority. Only about 30 percent of those in need are receiving treatment. But without the price reductions brought about by generic competition, almost all of the 2 million people in Africa now receiving treatment would be dead or would die soon.

The author also directs attention to important negotiations now underway at the World Health Organisation. These talks are designed to identify means to advance both innovation and access to the fruits of innovation. The idea is to explore reward systems that provide an incentive for the development of new medicines to meet priority health needs in developing countries, and to make those products available on an affordable basis.

The need for new arrangements is apparent. The patent monopoly system, the current means to ‘incentivise’ corporate sector R&D, is not working for developing countries.

Patents are not worth much if they offer monopolies on sales to a population that — no matter how large — has little buying power.

Developing countries comprise 80 percent of the world’s population but amount to only 13 percent of the global market for medical products. As a result, there is little corporate sector R&D devoted to the needs of developing countries. A review by Doctors Without Borders found that of 1,556 new drugs put on the market between 1975 and 2004, only 21 were for “neglected diseases” — diseases endemic to developing countries.

Pharmaceutical companies commonly price the new drugs that they do develop, intended for rich country markets, far out of reach of patients in Africa. Compounding the inequity, most important new drugs are developed with very substantial government support.

A system that fails to respond to key health needs — and then prices what it does develop out of reach — is not one that recommends itself.

Isn’t it worth exploring other ideas, like non-patent prizes to ‘incentivise’ R&D, with the resulting fruits of the innovation made available at competitive prices?

Perhaps readers might have been better able to assess the author’s views on these matters if he had identified his organisation’s ties to the pharmaceutical industry. A host of multinational drug companies are among the corporate members of the author’s Free Market Foundation in South Africa. These include GlaxoSmithKline, Johnson & Johnson Medical, Novo Nordisk, Roche and Wyeth.

Ideologues and those would prioritise the narrow commercial interests of Big Pharma over public health objectives have reason to reflexively defend a patent monopoly-based R&D system that is not working for the developing world.

For everyone else, the rising interest in new institutional arrangements to promote the complementary public health objectives of innovation and access is something to embrace.

==
The author is director of Essential Action, a public health advocacy and corporate accountability group based in Washington, DC.

This op-ed responds to a previously published op-ed by Temba Nolutshungu. Here is the text of that piece:

The Daily Times (Malawi)
My Point of View- Neo-colonialist NGOs
By Temba Nolutshungu
30 April 2008

Soon after the real colonialists had left Africa, a new breed of Western colonialists emerged: the statist non-governmental organisations that want to save us from everything from genetically-modified food to globalisation–and growth.

These “consumer” and humanitarian groups and “development” charities are united in the belief that modern industrial civilisation, profit and competition are unethical. In their view, people, particularly in developing countries, would be better served by state control that puts “equity” and the redistribution of wealth ahead of the economic dynamism that has enriched the West and such eastern countries as Taiwan, Japan and South Korea.

But despite their claims to speak for the poor, only a few hundred of the several thousand NGOs registered at the United Nations come from developing countries. The vast majority are from the USA, with many from Britain, France and Germany.

These groups have influence way beyond their size. Many poor countries do not have the technical capacity to formulate their own policies for services such as health, so they consult NGOs or bodies such as the World Health Organisation (WHO), mandated with providing impartial scientific advice to governments.

The WHO has been colonised by these NGOs, acting as policy consultants and playing a big part in formulating the WHO’s technical and policy advice to members. But the NGO advisors consistently get things wrong.

Take Aids. Because there is no cure, the only way to tackle its spread is to prioritise prevention, to stop the number of infections increasing every year. Of course treatment is essential but the NGOs pushed hard for most public money to be spent on drugs for those already infected–even though the worst affected countries do not have the doctors and clinics to administer the drugs. The WHO gave in, so infections continue to rise and treatment is haphazard.

A similar thing happened with malaria. For years, countries from India to South Africa successfully controlled malaria by spraying the insides of houses with DDT.

Environmentalists and NGOs played up scientifically unsound scare stories from the USA to demonise the pesticide and pushed for a ban: the WHO stopped recommending it in the 1990s, malaria soared globally and millions died. Recently, South Africa reintroduced DDT spraying and cases plummeted but few other countries have dared upset their NGO advisors.

Western pressure groups have also scared European consumers away from buying GM crops grown in Africa: Uganda has been directly threatened by European Union representatives and Kenya avoids GM.

NGOs operate at national level too, directly feeding governments with statist policies. In their latest campaign they argue that, because very few drugs have been developed for a handful of tropical diseases that occur in the poorest countries, patents prevent this and are inherently unjust.

They want bureaucrats rather than markets to determine what diseases are researched and they want subsidies for setting up medicine factories in Africa, where ingredients, technicians and managers would have to be imported and where there are very, very few laboratories to test quality: bad copies are often worse than no medicine at all as they encourage drug-resistance and virus mutation.

All this in the hope that removing profit will usher us into a magical new age in which cheap new medicines will become freely available to the poor –- never mind the fact that market-led research and development has produced the vast majority of all treatments available.

The final stupidity is that you could give every African every drug for free, to no avail: without the infrastructure to monitor and administer them, many drugs are useless or dangerous.
The NGOs achieved this by lobbying African governments at the WHO: the similarities between the NGOs’ campaign literature and the official position of Kenya, a leading proponent of the R&D Treaty, are too many to be a coincidence.

Of course, many African governments like these schemes because they help protect their own pharmaceutical companies or transfer the blame for their own failures in health care onto foreigners such as multinational pharmaceutical companies. And these schemes are being aired in Geneva this week at the WHO’s Intergovernmental Working Group on Public Health, Innovation and Intellectual Property (IGWG): member states need to put the real needs of the poor first and kick out the counter-productive ideology.

Statist NGOs have enormous influence on public opinion, the UN and African governments even though their ideologies have been shown not to work in their own countries: before taking the neo-colonialists’ medicine, we must carefully read the label or suffer nasty side effects.

IP Watch: WHO IP And Health Group Concludes With Progress; Tough Issues Remain For Assembly

Intellectual Property Watch
6 May 2008

WHO IP And Health Group Concludes With Progress; Tough Issues Remain For Assembly
By Kaitlin Mara and William New

The World Health Organization (WHO) negotiations on public health, intellectual property and innovation ended Saturday with substantial progress toward consensus on a draft strategy but with a plan of action remaining and the most contentious articles in the strategy still under brackets – indicating lack of agreement – as the paper goes to the World Health Assembly.

The air in the room was cautiously optimistic as WHO Director General Margaret Chan’s closing comments praised the assembled delegates at the 28 April to 3 May Intergovernmental Working Group on Public Health, Innovation, and Intellectual Property (IGWG) for reaching consensus on 107 paragraphs (many through deletions) that had been unresolved at the meeting’s start Monday.

The group’s mandate from the 2006 Health Assembly was to agree on a strategy and plan of action to boost research and development of, and access to, treatments for diseases disproportionately affecting developing countries, in time for this year’s annual assembly. If sufficient agreement is reached on the remaining items and the plan of action, implementation of the strategy should follow.

But there was also a sense from many delegates that substantive work lies ahead, and some nongovernmental organisations expressed disappointment at the IGWG’s perceived lack of strong commitment to public health, and the potential lost opportunity to make a profound difference.

While the global strategy being drafted by the group is not legally binding, it is being taken seriously by governments and other stakeholders because it could have a significant impact on policy. “It is a political document,” said one official. “It can have a lot of weight.”

Both developing and developed countries representatives found positive things to highlight about the IGWG, though it is clear that outcomes are not yet guaranteed and large gaps remain between what different stakeholders want from the draft strategy. Much of the work was done in closed informal sessions, often into the night, participants said.

Some key outcomes or debates were the proposed creation of an expert group on financing and the coordination of R&D, a mention of prizes as a possible alternative incentive for research and development, and policies on human clinical trials, competition, counterfeit medicines, and the role of the WHO on international IP and innovation issues.

Also significant was the apparent removal of advance market commitments, which would have created a mechanism for ensuring a market for new drugs, sources said. One source also said there was now a separation of provisions relating to access from those relating to intellectual property rights.

Ambassador Tom Mboya Okeyo of Kenya said the outcome’s impact will take time to see but that it was a good step. He noted consensus on provisions on access to medicines, and on flexibilities in the international IP system to accommodate access. Also agreed were several provisions that could strengthen innovation on essential medicines and encourage sustainable financing mechanisms, and provisions that could help protect traditional medical knowledge, all of which are important to developing countries, he said. The next challenges are in ensuring the key actions outlined in the strategy are implemented quickly, he said, adding that he hoped the WHO director general could mobilise funds for that purpose.

Suriname delegate Miriam Naarendorp called the week’s outcome the “start of the battle,” with the plan of action and implementation issues still to come. However, it was an important start, as, Naarendorp said, the IGWG was able to identify issues important to developing countries, and that the developing nations “stood firm on things that mattered” and had created a document that the WHO could not ignore.

An official from a leading developing country praised the outcome as successful as “so many member states agreed on so many things.” And a third developing nation delegate added that “we’ve made tremendous progress here [and] I expect we will get it finished at the World Health Assembly.” The assembly meets from 19 to 24 May.

A key developed country source was more concerned that the IGWG seemed to have averted potential negative consequences, saying that “the possibility of impact on the IP system has been reduced” and that “there were a lot of proposals that could have undermined innovation.”

Nongovernmental groups had higher hopes going into the meeting, for an outcome with profound effects on health product development for the poor. Over one hundred civil society organisations and patients groups signed a “joint declaration” (pdf) stating that “health is a fundamental human right and a necessary condition for human dignity” and calling for the IGWG to find sustainable solutions to encourage both innovation in healthcare and access to the fruits of that innovation, and several eminent academics signed a similar statement asking for IGWG delegates to consider “the exploration of new and innovative mechanisms that seek to correct the deficiencies of the current system” of drug development and delivery.

Draft Strategy Text Advances

The latest available version of the draft strategy was from the start of the last day, 3 May. Click here to read the 3 May version [pdf].

Delegates were able to reach full consensus on five out of eight elements within the draft global strategy, which includes principles for using the intellectual property system to maximise public health impact, particularly in innovation related to developing country diseases. Full consensus sections were element 1, on prioritising research and development needs; element 2, on promoting research and development; and element 3, on building and improving innovative capacity.

Article 3.4 outlines ways to support “policies that will promote innovation based on traditional medicine,” as well as Article 3.5.b, which encourages “the establishment of award schemes for health-related innovation.”

Article 5.3.a, which also saw consensus, mentions prizes as an innovation incentive, an issue important to developing countries and some nongovernmental participants. Barbados and Bolivia submitted a document at the outset of the week’s meeting proposing alternative incentive schemes for drug innovation in the form of prize funds for inexpensive tuberculosis diagnostic testing, for a Chagas disease treatment, for priority medicines and vaccines, and for cancer treatments. The document also calls for a global agreement on funding clinical trials as public goods.

Element 4, on transfer of technology, was largely agreed upon, with the exception only of element 4.1.b, which reads “promote transfer of technology and production of health products in developing countries through investment and capacity building, including by providing guidance on appropriate technologies.” As of the end of 2 May, this article was listed “consensus pending USA.” One developing country official said that in general the United States was “a bit tough” in negotiation, referring to the fact that the country was often the sole voice blocking consensus (though there may have been others unspoken). The US delegation included an IP negotiator from the US Trade Representative’s office.

Element 7, on promoting sustainable financing mechanisms, also reached full consensus, as did element 8, on the establishment of monitoring and reporting systems. The agreement on element 7 was reached only after a lengthy debate, Barbados said during the IGWG’s closing plenary session. Article 7.3, which detailed several strategies for the establishment of a global R&D fund to address gaps in diseases affecting developing countries, including the use of prizes and rewards as well as earmarked funds for patent buyouts to ensure access to medicines, was deleted by consensus.

Barbados asked during the final plenary that it be officially noted that this consensus was predicated on an understanding by Barbados and the rest of the Caribbean group, as well as Bolivia, that these issues be addressed under 7.1.a. That article calls for the establishment of a “results-oriented and time-limited expert working group under the auspices of the WHO and linking up with other relevant groups to examine current financing and coordination of research and development, as well as proposals for new and innovative sources of financing to stimulate research and development” relevant to developing countries.

Element 5, on the application and management of intellectual property to contribute to innovation and promote public health, and element 6, on improving delivery and access, proved the hardest on which to reach consensus.

Still remaining to be resolved are issues of data-sharing, specifically through the creation of easy-to-use global databases on the status health-related patents (under article 5.1.c); on the training of patent examiners in intellectual property application and management, and possibly on TRIPS flexibilities (under article 5.1.e); on promoting competition to increase availability of health products under article 6.3, and particularly on support for the production/introduction of generic medicines (under 6.3.a). Another issue under debate in the strategy related to agreements that impose stricter intellectual property standards than agreements in the multilateral system (so-called TRIPS-plus provisions).

On 5.1.h, which originally stated, “establish measures to avoid unethical experiments involving human beings as a requirement for registration of medicines and technologies,” sparked a lengthy discussion on 2 May on the nature of ethics in human testing. Points discussed included: the difference between clinical tests for new drugs, or the bioequivalence tests done when generics are marketed, the ethics of testing new drugs against placebos when existing treatments are available for comparative testing (the Declaration of Helsinki, which lays out ethics of healthcare research, and says that new methods of treatment should be tested against the best existing treatments, where available, and not placebos), and the ethics of repeating a clinical test because the original tester has exclusive control over the results of first test and will not make the data public. Also of interest, especially to developing countries, was ensuring post-trial access to drugs by study participants, which the Declaration of Helsinki calls “necessary.”

The article eventually passed consensus on the condition it be moved from element 5.1 on information sharing and capacity building on health-related innovation to element 6.2, which covers ethical review and quality/safety regulation. The final text reads: “promote ethical principles for clinical trials involving human beings as a requirement of registration of medicines and health-related technologies, with reference to the Declaration of Helsinki, and other appropriate texts, on ethical principles for medical research involving human subjects, including good clinical practice guidelines.”

Other debates under element 5 included a provision on preventing anti-competitive practices related to IP rights, language on encouraging respect for flexibilities in the World Trade Organization Agreement on Trade-Related Aspects of Intellectual Property Rights (TRIPS), and a possible clause on counterfeit health products, including a definition. Some sources said an effort is being made to clarify the distinction between counterfeit products and generic products.

Also under element 5, a discussion was held on the role of the WHO on IP-related matters. Officials present from the World Intellectual Property Organization and the World Trade Organization signalled resistance to a proposal to create a formal coordinating body between agencies under Article 5.1.i. Creating a formal coordination effort would, a WIPO official said, just “add governance issues” to the already functioning informal collaboration that currently exists.

One participant said an informal relationship was seen as possibly minimising interagency turf battles. Still, some participants viewed the outcome as having strengthened the role of the WHO in IP issues. Consensus Article 5.1.f states, “strengthen efforts to effectively coordinate work relating to intellectual property and public health among the secretariats and governing bodies of relevant regional and international organizations (including WHO, WIPO and WTO) to facilitate dialogue and dissemination of information to countries.”

The traditional knowledge debate discussed earlier in the week (IPW, Public Health, 1 May 2008) was resolved after the Kenyan-led informal session came up with the text “facilitate, where feasible and appropriate, possible access to traditional medicinal knowledge for use a s prior art in examination of patents, including, where appropriate, the inclusion of traditional knowledge information in digital libraries.”

Lost Opportunities and Some Progress

Concerned entities and other nongovernmental organisations participating at the event were not entirely pleased with the outcome of the negotiating process.

Médecins Sans Frontières (MSF) sharply criticised the IGWG, saying it had “failed to take concrete action towards reforming a medical innovation system that largely disregards the health needs of millions of people in developing countries.” Tido von Schoen-Angerer, director of MSF’s access to medicines campaign said that negotiators had not “risen to the challenge” of “prescrib[ing] change to a broken system.” He called the working group a “lost opportunity,” particularly because there had been no consensus on the development of alternative research and development incentives.

Ethan Guillen, executive director of Universities Allied for Essential Medicines (UAEM) also expressed surprise at “the lack of bold commitment by most of the rich countries” and said “that there had to be stiff negotiations on the idea that the cost of medicines impedes access in the developing world makes you wonder if some negotiators hadn’t noticed that busloads of American retirees have to hop across the US border to Canada to get drugs they can afford.”

Sarah Rimmington, an attorney at public interest organisation Essential Action, said IGWG was meant to address how “the current corporate sector system of medical R&D, which is based on patent monopolies, has largely failed people in developing countries.” Rimmington said while the IGWG had taken an “important first step by agreeing to explore some common sense measures to address this failure,” such as innovation incentives not reliant on patent monopolies, consensus on actual implementation processes was not reached. This lack of agreement was, she added, largely due to “resistance from developed countries such as the United States, the EU, and Canada” and added that it “is hard not to wonder if pressure from the brand-name pharmaceutical industry – which is based in developed countries and remains ideologically committed to patent monopolies – influenced this disappointing outcome.”

Jamie Love of Knowledge Ecology International said the IGWG “did next to nothing on identifying R&D priorities, estimating funding needs, or creating a framework for sustainable funding for priority R&D, three tasks central to its mission.”

Harvey Bale, director general of the International Federation of Pharmaceutical Manufacturers and Associations (IFPMA), when asked about whether this meeting represented progress toward the goal of addressing the problem of neglected diseases, said it “has lost focus on that,” but added that there was hope it could come back. He stressed the importance of advanced market commitments, or guarantees of a market in the event a medication or vaccine is developed (which were deleted from the draft strategy). He also stressed the importance of partnerships for development that link companies and the public sector in coordinated research efforts.

But there were also some positive views. Guillen said his group was “pleased to see the advancement… of important issues like technology transfer” in the draft strategy and said UAEM is “hopeful that consensus recommendations on open licensing and other technology transfer provisions agreed to during this round will send a strong message to universities… to adopt policies that will free up the tools of innovation and make medicines discovered on campuses available at low-cost in the developing world.”

Love was pleased to see that advanced market commitments had come out of the draft strategy and prizes had been included.

Nicoletta Dentico, policy and advocacy manager at the Drugs for Neglected Diseases Initiative (DNDi) said “the outcome of this intense week-long negotiation shows that some uncertain lights are looming, but still in a forest of thick shadows” that research on essential medicines still faces the “resistance of those who have set the direction of innovation so far” but that hopefully the “”spirit of Geneva” [would] clear, in the face of poor people’s needs, the shadows.”

MSF has said that, as the IGWG failed to arrive at strong conclusions, it is now up to the World Health Assembly “to translate bold ideas into concrete action.”

Kaitlin Mara may be reached at [email protected] William New may be reached at [email protected]

Cheaper drugs are as important as improved health infrastructure – The New Times (Kigali) op-ed

The New Times (Kigali)
May 6, 2008

Cheaper drugs are as important as improved health infrastructure
Robert Weissman

Thompson Ayodele is of course right to emphasize in his recent opinion piece (“Africa’s Failing Infrastructure Renders Compulsory Licensing Pointless,” April 28) the urgent necessity of improving Africa’s healthcare infrastructure.

Unfortunately, invoking the infrastructure issue is for Mr. Ayodele a technique to disparage current debates at the World Health Organization (WHO) over the means to improve pharmaceutical research and development (R&D) and to lower drug prices.

Mr. Ayodele is completely mistaken in suggesting that the need to strengthen health systems is a reason not to pay attention to the price of drugs. There is no trade off between the two.

Poor people in Africa need more investment in healthcare and better functioning health systems. But they also need access to life-saving medicines, and new R&D directed to the priority health needs of the continent.

The WHO discussions aim to identify means to advance both innovation and access to the fruits of innovation. The idea is to create incentives for the development of new medicines to meet priority health needs in developing countries, and to make those products available on an affordable basis.

Mr. Ayodele may have an ideological commitment to the patent monopoly system for R&D, but there is no serious argument that it is failing developing countries – especially the world’s poorest countries.

Big Pharma charges far more for its patent monopoly-protected medicines than patients or governments in Africa can afford. At thousands of dollars a year per person – and sometimes more than $100,000 per year – drug prices are gouging consumers in rich countries.

These prices are completely out of reach for all but the elite in developing nations. Generic competition is the key mechanism to lowering prices and making drugs affordable in Africa and other developing countries.

The case of HIV/AIDS drugs is illustrative. Ten years ago, before generic competition, brand-name companies charged roughly the same price for lifesaving HIV/AIDS drugs in Africa as they did in rich countries – $10,000 a year per person, or more. An HIV diagnosis was a death sentence.

Today, the price is as low as $100 per person – a price decline that leveraged a huge increase in donor money that otherwise would not have been made available. The severe problems with healthcare infrastructure notwithstanding, two million people living with HIV/AIDS in Africa are today receiving treatment.

Much more needs to be done – and improving infrastructure is a top priority. Only about 30 percent of those in need are receiving treatment. But without the price reductions brought about by generic competition, almost all of the 2 million people in Africa now receiving treatment would be dead or would die soon.

Rather than criticizing countries like Thailand that are issuing lawful compulsory licenses – government authorizations of generic competition for products that remain on patent – Mr. Ayodele should be pointing to them as an example to be followed.

They are, after all, promoting market competition and lowering price. In Thailand’s case, it is acquiring generic versions of a heart disease drug for 1/70th the price charged by the brand-name company.

Lower prices from compulsory licenses have enabled Thailand to triple the number of people receiving important medical treatments. But African and other developing countries need more than cheaper drugs.

They need medical R&D for priority health problems that brand-name drug companies have no incentive to address.
Patents are not worth much if they offer monopolies on sales to a population that – no matter how large – has little buying power.

Developing countries comprise 80 percent of the world’s population but amount to only 13 percent of the global market for medical products. (Africa represents less than 2 percent of the global pharmaceutical market.)

As a result, there is little corporate sector R&D devoted to the needs of developing countries. A review by Doctors Without Borders found that of 1,556 new drugs placed on the market between 1975 and 2004, only 21 were for “neglected diseases” – diseases endemic to developing countries.

At the World Health Organization negotiations, debate is underway about different arrangements to spur private sector R&D – ideas that would pay drug companies, but not lead to high drug prices. One exciting idea revolves around prize funds, with drug innovators paid large cash awards, but all drugs being made available, immediately, as low-priced generics.

Ideologues and those who would prioritize the narrow commercial interests of Big Pharma over public health objectives have reason to reflexively defend a patent monopoly-based R&D system that is not working for the developing world.

For everyone else, the rising interest in new institutional arrangements to promote the complementary public health objectives of innovation and access is something to embrace.

Robert Weissman is director of Essential Action, a public health advocacy and corporate accountability group based in Washington, DC.

This op-ed responds to a previously published op-ed by Thompson Ayodele. Here is the text of that piece:

The New Times
April 28, 2008

Africa’s failing infrastructure renders compulsory licensing pointless
Thompson Ayodele

Switzerland is about to become ground zero for the future of health policy in Africa. Next week, the World Health Organization’s (WHO) Intergovernmental Working Group will convene in Geneva to discuss public health, medical innovation, and intellectual property.

Many participants are expected to express their support for efforts to undermine patent protections for drugs. In doing so, however, these attendees ignore the more fundamental problem facing poor African nations — dilapidated healthcare infrastructure.

The anti-patent crowd believes that patents keep prices high and drugs out of the reach of the poor. They blame pharmaceutical firms for the suffering of the impoverished and call on developing nations to employ patent-revoking compulsory licenses that encourage the production of unauthorized generics.

But even if medicine were available for free, as it often is in poor nations, dysfunctional institutions and personnel ensure that the needy can’t access it.

Despite unprecedented quantities of monetary aid to the ministries of health of many African countries, health systems on the continent have languished.

Between 1990 and 2005, Development Assistance for Health (DAH) increased from $2.5 billion to over $13 billion. Overall, about ten percent of Africa’s healthcare expenditure is financed by donor aid.

And yet over 50 percent of Africans lack access to essential medicines, according to the WHO. Around the world, more than 10 million children in developing countries die unnecessarily from diseases that are easily preventable and cheap to treat, like diarrhoea, measles, and malaria.

Furthermore, up to 80 percent of Africans have to pay for treatment straight from their own pockets. In short, public health systems are failing to deliver. Why? For starters, nearly all foreign aid must first pass through health ministries before reaching patients.

According to studies undertaken by the WHO and the Center for Global Development, donor nations rarely know what happens to their money after they hand it over to a recipient government.

As a result of these lax controls, money is routinely subverted by health officials for private gain. One problem is leakage of drugs from the supply chain. Publicly funded drugs can fetch a higher price if stolen and resold on the black market.

Recent surveys in Nigeria show that 28 public health centers received no drugs from the federal government over a two-year period.

Meanwhile, a 2001 study by the World Bank showed that fewer than half of government health facilities in the Nigerian states of Lagos and Kogi had received any drugs from the federal government.

Last year, Dora Akunyili, the director general of Nigeria’s National Agency for Food and Drug Administration and Control, disclosed that it was commonplace for donated drugs such as Vitamin A capsules, Mectizan and Coartem tablets, and oral rehydration salt to be pilfered and resold on the open market.

With incidents like these in mind, the Global Fund has considered suspending two grants to Nigeria totaling $80 million. The Fund has already terminated grants to Uganda and Chad because of bad management, a lack of transparency, and poor implementation of grant monies.

Theft is not the only problem. Countless other forms of corruption plague Nigeria’s health system, including mismanagement of funds at the local level; employee absenteeism; extortion of patients by staff members; and the abuse of procurement contracts for hospital supplies.

According to Human Rights Watch, “the government’s failure to tackle local-level corruption violates Nigeria’s obligation to provide basic health and education services to its citizens.”

Compulsory licenses will do nothing to solve these critical issues. And they’d unleash a whole host of new problems concerning access and safety.

Last year in Thailand, for example, the government used compulsory licenses to grant the state-run Government Pharmaceutical Organization (GPO) the right to manufacture generic versions of AIDS and heart-disease medications.

Many activists applauded the move, even as Thai leaders turned down the Global Fund’s offers of free medicine. Unfortunately, domestic production has proved too expensive, and access to needed medicines has decreased substantially for sick Thais.

Further, the GPO has a history of producing shoddy products, including a different anti-AIDS medication called GPO-Vir. This substandard antiretroviral actually accelerated the resistance of HIV to treatment, consigning scores of Thai patients to early death.

Yet Thailand’s patent theft continues. Last month, the nation announced that it would rescind the patents on four cancer drugs.

As long as healthcare delivery remains in the hands of dysfunctional governments, the health of the poor in developing nations will never improve.

Aid groups and policymakers must instead enlist the help and expertise of the private sector. The advantages of this are two-fold.

First, it would reduce corruption. Corruption certainly exists in the private sector as well, but private enterprises with ethical problems risk exclusion from the next round of programs and contracts.

Second, competition governs the private sector. Firms that fail or receive low marks from customers or aid organizations will lose out to competitors. Market participants are forced to improve productivity and patient care or face extinction.

In the public sector, by contrast, organizations or governments proven inefficient tend to get more money — even as they’ve demonstrated themselves incapable of doing the job.

According to the International Finance Corporation, 60 percent of the $16.7 billion spent on health in Africa in 2005 was privately financed, with half of that spent in the private sector. It is time to harness this vast sum so it can work for patients in an efficient and equitable way.

Rather than encourage the willful destruction of drug patents, conference attendees ought to call for measures that would actually improve the health of those in poor nations, like increased investment in infrastructure. To do otherwise would hurt those who most need help.

Thompson Ayodele is the Executive Director of Initiative for Public Policy Analysis, a Lagos-based think tank.

Contact: [email protected]

Essential Action Comment on the Latest Round of WHO R&D Talks

Comment of Sarah Rimmington, Attorney, Essential Action upon the conclusion of the World Health Organization’s Intergovernmental Working Group on Public Health, Innovation and Intellectual Property (IGWG)

The world community met this week at the IGWG because the current corporate sector system of medical R&D – which is based on patent monopolies – has largely failed people in developing countries. Despite difficult and incomplete negotiations, delegates took an important first step today by agreeing to explore some common sense measures to address this failure and promote developing country focused innovation plus access. This includes an agreement to explore R&D incentives like prizes that do not rely on patent monopolies and the prospect of charging high drug prices as a reward, and to encourage future discussions of an R&D Treaty.

Despite this progress, much work remains to be done to promote R&D models that will work for the developing world. Consensus was not reached on concrete proposals to actually implement the urgently needed new incentive mechanisms because of resistance from developed countries such as the United States, the EU, and Canada. A significant amount of negotiating time was lost debating core principles such as the role of patents in creating barriers to access to medicines, and the importance of promoting the use of already-agreed to flexibilities available under international trade law to promote access to affordable generic medicines where patent protections remain a problem.

It is hard not to wonder if pressure from the brand-name pharmaceutical industry – which is based in developed countries and remains ideologically committed to patent monopolies – influenced this disappointing outcome.

But it’s not too late. Member countries have another year to finalize the R&D agreement; they must use this time wisely by taking concrete steps such as coming to an agreement on financing proposals for the new incentive mechanisms.

For more information, contact Sarah Rimmington (in Geneva until May 5) (+41)(0)76-269-2246,
[email protected]

IP Watch: WHO Members Inch Toward Consensus On IP, Innovation And Public Health

Intellectual Property Watch
2 May 2008
WHO Members Inch Toward Consensus On IP, Innovation And Public Health

By Kaitlin Mara and William New

Members of the World Health Organization (WHO) gathered this week to address innovation and intellectual property issues in public health saw hope for agreement on a strategy paper focused on the needs of developing countries, particularly on neglected diseases. But with two days remaining in the negotiations, difficult issues on intellectual property rights and the action plan remained unresolved.

The WHO Intergovernmental Working Group on Public Health, Innovation and Intellectual Property (IGWG) is meeting from 28 April to 3 May, as a part of its resumed second session (the second session begin in November 2007)(IPW, WHO, 9 November 2007). The current round of negotiations is under mandate to create a consensus document for presentation at the World Health Assembly, which will take place later this month.

In her opening remarks to the IGWG, WHO Director-General Margaret Chan said that an “agreed framework can make the cycle of product discovery, development and delivery more efficient and more sensitive to health needs in the developing world” by giving the international community a “common tool” to leverage against health problems. She stressed the importance of the negotiations moving forward “as rapidly and efficiently as possible,” and urged a continuation of the “sense of urgency” seen in past months.

Further pressure for resolution has been placed on negotiators by some developed countries who would like to see the IGWG discussions end this week, and to pull the WHO back from involvement with IP issues, according to some participants. Others thought that the negotiations should not be rushed, and one developing country official said, “I hope we don’t do in haste what we will repent later.”

This week’s debate is the result of several years of intensive discussion at the WHO on policies to address the problem that the existing intellectual property system lacks economic incentives for the private sector to invest in research and development (R&D) for diseases primarily affecting those who cannot afford to pay the higher prices necessary to recover R&D costs.

But a larger issue of the role of the WHO in discussions relating to intellectual property is underlying the talks. Many feel the issues belong primarily in the World Trade Organization, World Intellectual Property Organization, or in national laws. But others see the WHO with the lead on public health issues as having been sidelined in global debates as they relate to IP and public health, even as those debates have resulted in rules that have possibly had a pejorative effect on public health.

“The IGWG is a historic opportunity and this should not become a historic failure for lack of response,” Médicins sans Frontières’ Tido von Schoen-Angerer told the plenary. “Governments, and the WHO, must not abdicate from their responsibilities, or pass the buck to others. We are asking you to strengthen WHO’s role in intellectual property and health, to change the way R&D is prioritised and financed so that paying for the research does not equal prohibitive prices, and to take measures to increase generic competition.”

Draft Text Taking Shape

While most negotiations have happened behind closed doors, on 1 May WHO members met as a whole in an attempt to hammer out consensus on the draft global strategy on public health. The talks were able to cover elements two, three and four out of the eight-element draft strategy – covering, respectively, promoting research and development, building and improving innovative capacity, and transfer of technology – and had begun to discuss element five, on the application and management of intellectual property to contribute to innovation and promote public health.

Remaining aspects of element five are expected to be contentious, according to some participants. In general, consensus is being achieved through a relative weakening of provisions, often, but not always, along north-south lines. Compromises involved the insertion of phrases like “possible” and “appropriate.”

The morning’s negotiations focussed on element two, promotion of research and development. Convergence was reached on accessibility to libraries and technical support to create compound libraries in developing countries (Article 2.2.b), and the related article (2.4.c) on the creation of open databases and compound libraries. The United States sought to delete the second article as it felt it was redundant, sparking discussion on the issue.

The dissemination of publicly or donor-funded medical inventions and know-how (Article 2.4.d), and the “incorporation of research exemptions in legislation of developing countries” for public health purposes (Article 2.4.e) were both contested by the United States. Korea agreed with the US on 2.4.d, as one of the suggested ways to disseminate medical know-how was through open licensing and the Korean delegate was unsure if his country had a policy allowing for such licensing. Brazil and India felt that open licensing was a useful addition to the paragraph, and India mentioned that the use of open source technologies in India was very effective. Jamaica supported India and Brazil. A distinction also was made between proprietary and non-proprietary databases. A compromise was reached with the language “including but not limited to open licensing.”

On 2.4.e, which reads “consider the incorporation of research exemptions in legislation of developing countries to address public health needs, consistent with the TRIPS and the Doha declaration on TRIPS and Public Health,” the United States asked for the paragraph to be deleted, as such issues would be dealt with in the IP chapter (element 5). Delegations pointedly asked the US delegation to explain its problem with research exemptions, as they are covered in both the TRIPS agreement and in US legislation. Japan supported the United States, which argued that the term ‘research exemptions’ was not well-defined, and it was unclear as to its actual scope.

The encouragement and promotion of traditional knowledge (and traditional medicines) was another key debate. Suriname wanted to ensure that traditional medicine is protected from being carried away from its nations of origin and brought back as patented matter. The traditional knowledge clause in element 5, Article 5.1.f, on the creation of digital libraries of traditional knowledge in order to prevent misappropriation, caused much disagreement. Some delegates were uncertain if discussions on traditional knowledge even belonged in the WHO negotiation. Others could not see how a digital database could prevent misappropriation, as it would offer greater access to the knowledge. Several new suggestions were offered, but after lengthy discussion no convergence was forthcoming so the chair suggested interested parties meet outside the plenary. Kenya is chairing this side session.

Another discussion in element 5 reflected a debate that has arisen at other institutions in Geneva that the training on IP in developing countries, such as of patent examiners, should fully reflect public health priorities.

Element 5 seems likely to be difficult to negotiate, with upcoming discussions on provisions such as how to address research involving humans. Delegates on 1 May discussed Article 5.1 and several of its subsections, but had trouble reaching consensus on several topics. In addition to traditional knowledge, a clause on strengthening “education and training in the granting, application and management of intellectual property from a public health perspective” also presented a problem. The US wanted to strike the word “granting” from the paragraph, and other members proposed adding specific references to flexibilities contained in the TRIPS agreement and other instruments. Consensus was unable to be reached.

Under Article 5.1, on the management of intellectual property in a manner that maximises health-related innovation, Suriname was concerned about the ethics of clinical trials, citing examples in which such trials have been conducted in developing countries, aiding medical innovation on drugs that were subsequently out of the price range of individuals who had participated in trials. Suriname wishes to add “maximises health related innovation and access” to the clause; consensus is pending agreement on that addition.

Civil Society Views

The hottest points of disagreement have tended to arise over practical solutions for solving this problem, reflected in the wide variation in proposals from civil society groups addressing negotiators. Public interest advocacy group Knowledge Ecology International’s Jamie Love has suggested prizes and prize funds replace patents for neglected diseases, and expressed disappointment that most references to such systems in the strategy paper appeared to be surrounded by brackets indicating lack of consensus on their presence in the text. Love suggested that if the governments are not ready at this point in time to achieve real improvements, then perhaps the process should wait for another time.

International Federation of Pharmaceutical Manufacturers and Associations (IFPMA) Director General Harvey Bale said the industry group wants to preserve strong intellectual property protection, which it says promotes innovation, and instead focus on market incentives outside of IP, such as advanced market commitments (AMC) and “fast track” approval for drugs targeting developing country diseases. An AMC is a guarantee of a market in the event a medication or vaccine is developed in order to incentivise the development of health solutions in diseases or for areas where the existence of a market is uncertain or too small to compensate for R&D costs.

Health Action international also said that WHO must have a clear mandate to work in IP and health, and that the final draft strategy should not dilute flexibilities in IP enforcement already guaranteed under the WTO’s Trade-Related Aspects of Intellectual Property Rights Agreement. The European Generic Medicines Association and the International Generic Pharmaceutical Alliance, represented by Greg Perry, said data exclusivity must not be used to create market exclusivity beyond patent protection.

“IGWG must systematically address innovation and access to medicines” and should “delink the cost of research and development from the price of developed products,” said Sarah Rimmington of Churches’ Action for Health. The role of WHO should be strengthened on IP and issues in health, and the organisation should “provide active guidance, specifically on TRIPS flexibilities.”

The International Alliance of Patients Organizations called for IGWG recognise patients and patient organisations as key stakeholders.

MSF’s von Schoen-Angerer urged that the medical R&D process be government-led, and said it appeared wealthy countries objected to a proposed R&D fund without offering alternatives.

Kaitlin Mara may be reached at [email protected] William New may be reached at [email protected]

Statement at WHO meeting on public health, innovation and intellectual property

This statement was written by delegation members from Essential Action, Third World Network, and Universities Allied for Essential Medicines.

1 May 2008

Statement of CMC – Churches’ Action for Health at WHO IGWG II bis

My name is Sarah Rimmington, and I am speaking on behalf of the CMC Churches’ Action for Health delegation. We are pleased to address the WHO Intergovernmental Working Group (IGWG) on public health, innovation and intellectual property.

Medical research and development breakthroughs have made the world a better and healthier place, thus serving the mission of justice, peace and integrity of creation. Vaccines, antibiotics and drugs for conditions such as HIV/AIDS have kept countless millions alive and reduced untold suffering.

The world — and especially developing countries — needs more innovation. To have public health benefit, however, the fruits of the innovative process must be available to the people who need them.

The current patent monopoly-based system of R&D has proven inefficient at advancing a needs-driven public health agenda. This is particularly true regarding the needs of the vast majority of the world’s population who live in developing countries.

The patent monopoly-based system of R&D has also resulted in excessively high prices for important health products, creating serious access problems particularly for developing countries.

The global strategy and plan of action that comes out of the IGWG process thus must systemically address both innovation and access to medicines – “I plus A”.

To address the challenges of I plus A, we strongly believe the strategy and plan of action must promote incentive proposals that de-link the cost of R & D from the price of the products developed. This approach has also been strongly endorsed by a group of Nobel laureates and academics earlier this week.

Health products must be widely accessible if R&D is to be relevant for developing countries.

It is also of critical importance for member states to strengthen the role of the WHO with respect to intellectual property issues as they relate to public health.

WHO is the leading multilateral institution on public health. It has for many years been providing guidance, technical and policy support to developing countries, and should continue to do so proactively.

In this respect, we hope to see the global strategy and plan of action take a step forward to address developing country needs for WHO guidance, technology and policy support to achieve innovation plus access.

We strongly encourage this body to agree that the WHO must provide proactive guidance, particularly in the use of the TRIPS flexibilities to promote access, including compulsory licensing and exceptions to patent rights; the implementation of policies on strict patentability criteria to achieve public health objectives; implementing policies to prevent and remedy anti-competitive practices pertaining to patents for health products; and promoting licensing and technology transfer strategies that make medicines available at the lowest possible cost in the developing world.

Developed countries – in particular the EU and the US – make frequent use of these measures, but developing countries need assistance from a public health perspective. We see the WHO as being the appropriate lead institution on these matters.

We further support the inclusion in the strategy and plan of action the CIPIH report recommendation that encourages member states to avoid the incorporation of “TRIPS-plus” provisions in trade agreements and national legislation, because of their well-known negative impact on access to medicines.

Briefing Note: The Need for a Global Patent Database for Pharmaceuticals

The WHO’s Intergovernmental Working Group on Public Health, Innovation and Intellectual Property is considering a proposal to develop a global patent database for important medical inventions.

Adoption and implementation of such a global patent database on health-related inventions would advance important public health objectives. Although there are technical challenges in compiling such a database, these can be overcome. As a policy matter, it is very hard to imagine a legitimate basis for opposing such a proposal.

This briefing note provides background on the need for and potential benefits of a global patent database.

An .rtf version is available here: patentdatabase.igwg.rtf. A .pdf version is available here: patentdatabase.igwg.pdf.