Report on the IGWG

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

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

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

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

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

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

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

What does this outcome mean for patients around the world? 

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

Patents are the wrong target

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

Patient safety before profits

I totally agree with the article by kmlybecker below.  The seizure of illegal counterfeit pharmaceuticals by U.S. Customs increased 660% from 2006 to 2007.  According to these same authorities, 80% of the counterfeit drugs originates in China with the rest mostly coming from Pakistan, Egypt, Hong Kong and Taiwan.  Half of all internet drug sales are counterfeit where the internet “pharmacy’s” address is not identified.

Last week it was reported in Geneva that 41% of the drugs being distributed and administered in Nigeria are counterfeit - over half of which are unsafe, according to WHO.  So for every person that benefits from medicine in that country, another person is being placed at extreme risk – all in the name of greed.

Counterfeiting is cheaper than, yet just as profitable as, the illegal narcotics trade – with far lesser penalties!  For internet pharmacy customers in developed countries, buyer beware.  For poor people in developing countries who are unwittingly administered counterefit drugs, those behind such enterprises are guilty of assault if not murder.

The World Health Organization, World Intellectual Property Organization and World Trade Organization need to use whatever levers of persuasion they may have to motivate non-compliant countries to institute and enforce rigorous intellectual property protection laws and stamp out counterfeiting before the effects from unsafe drugs becomes a global epidemic.  If the countries that harbour pharamaceutical counterfeiters wish to play in the international arena then they should be held accountable on this issue and forced to put patient safety before ill-gotten profits.

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

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

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

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

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

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

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

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

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

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

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

Resolution on counterfeit medicine

On May 20th a draft resolution on counterfeit medical products was submitted to the World Health Assembly by the nations of Gambia, Ghana, Nigeria, Tunisia and the United Arab Emirates.  As the WHA turns to the challenges surrounding counterfeit pharmaceuticals, it is valuable to reflect on the threat counterfeit drugs pose.  In particular, it is important to address the dangerous claim that “counterfeits may at times have advantages . . . (and) may even protect patients”.  This argument has been presented by BUKO Pharma-Kampagne, a member of Health Action International. [1]

This paradoxical assertion is based on the mistaken reasoning that consumers who received counterfeit versions of risky drugs (e.g. Novalgin [active ingredient: dipyrone]) are better off with the spurious fakes than with the genuine drug.  This claim rests on the flawed assumption that the counterfeits themselves are not dangerous.  Although they may not be harmful, it may be the case that they are lethal.  Consider the parallels with collecting wild mushrooms in the woods.  It may be that the mushrooms collected are wonderful or they may be Death Caps.  The gamble patients take with counterfeit drugs is no different.   Given this, it is irresponsible to suggest that counterfeits may protect patients.  In the case of the genuine medicine, it is a known entity with known risks.  In the case of a counterfeit, the dangers are unknown and the chemical composition uncertain. 

Put simply, counterfeit drugs are always dangerous.  Their contents, production and handling are unregulated and of indeterminate quality and safety.  By definition counterfeits engender uncertainty and unknown risk.  In 1992 the WHO defined a counterfeit as:

“…one which is deliberately and fraudulently mislabeled with respect to identity and/or source.  Counterfeiting can apply to both branded and generic products and counterfeit products may include products with the correct ingredients, wrong ingredients, without active ingredients, with incorrect quantity of active ingredient or with fake packaging.” [2]

As the World Health Assembly sets about addressing the threat of counterfeit medicines they must acknowledge, in no uncertain terms, that counterfeits are always dangerous for consumers and detrimental to public health.  To do otherwise would undermine the pursuit of health for all and the regulatory regimes that guarantee the safety and quality of today’s medicines.  Counterfeit medicines are never an acceptable substitute for genuine medicines and should never be considered beneficial or as a solution to high drug prices for developing nations.  The risk is unacceptable for even the most vulnerable populations.  Everyone, including the poor, is entitled to high quality medicines.   To argue otherwise is dishonest and an injustice to patients.

[1] BUKO Pharma-Kampagne.  “Counterfeit Medicines – What Are the Problems?” PHARMA-Brief Special, Special Nr.1, 2007, pg.3. 
[2] World Health Organization.  Counterfeit Drugs:  Report of a WHO/IFPMA Workshop. WHO/DMP/CFD/92, Geneva:  World Health Organization, 1-3 April 1992.

Overview of the IGWG draft plan

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

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

Truth from the front lines

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

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

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

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

Patients speak out on global health and innovation – May 15, 2008

On May 15th (the eve of the 61st World Health Assembly), patient representatives from around the world gathered in Geneva to voice their concerns and provide recommendations on the draft plan of action as proposed by the WHO’s Intergovernmental Working Group on Innovation and Public Health (IGWG).

The following audio recordings from the patient meeting detail the key concerns and recommendations:

Introduction
Commentary from Durhane Wong-Rieger, Consumer Advocare Network (Canada) – 10 minutes
[odeo=http://odeo.com/audio/19206423/view]

Access to Medicines
Commentary from Regina Kamoga, Community Health and Information Network (Uganda) – 6 minutes[odeo=http://odeo.com/audio/19204143/view]

Counterfeit Drugs
Commentary from Reverend Anthony Ojeh (Nigeria) – 7 minutes[odeo=http://odeo.com/audio/19204173/view]

Need for Strong Regulatory Environment
Commentary from K.P. Tsang, Retina Hong Kong (China) – 7 minutes[odeo=http://odeo.com/audio/19204193/view]

Importance of IP
Commentary from Virginia Ladd, American Autoimmune Related Diseases Association (U.S.A.) – 7 minutes[odeo=http://odeo.com/audio/19204203/view]

Conclusion
Commentary from Durhane Wong-Rieger, Consumer Advocare Network (Canada) – 3 minutes[odeo=http://odeo.com/audio/19204253/view]

Outcomes from the Second Session of the IGWG

The World Health Organization’s Intergovernmental Working Group on Public Health, Innovation and Intellectual Property (IGWG) met for the continuation of its second session in Geneva at the end of April.  While they didn’t achieve consensus on all elements of their draft plan, there were many areas of agreement.

Some of the points of consensus include:

• Intellectual property rights are an important incentive for the development of new health-care products. This incentive alone does not meet the need for the development of new products to fight diseases where the potential paying market is small or uncertain;
• Encourage cooperation between private and public sectors to promote research and development;
• Support existing and new research and development groups and institutions, including regional centres of excellence in developing countries, to improve innovative capacity;
• Actions to be taken to improve healthcare delivery and access in developing countries include:
• Invest in developing health-delivery infrastructure
• Increase investment in human resource development in the health sector
• Develop effective country poverty reduction strategies
• Comply with good manufacturing practices for safety standards, efficacy and quality of health products

The full outcomes document from this latest IGWG meeting and the plan of action white paper are available on the WHO site.

Continued discussion of the contested elements will continue at the 61^st meeting of the World Health Assembly taking place in Geneva next week.

The relationship between intellectual property (IP) rights & drug efficacy and safety

Without any meaningful input from patients, intense efforts are underway at the WHO to weaken – or dismantle – the system of intellectual property (IP) rights that has produced nearly every life-saving medicine that is available today.  On behalf of a variety of both public and private sector special interests, anti-IP NGOs are using the Intergovernmental Working Group on Intellectual Property and Public Health (IGWG) as a vehicle to weaken the rules for drug innovation and development by promoting the expropriation of patent rights through compulsory licenses.

Issues of innovation, access and safety are of keen interest to patient advocates. The regulatory framework that supports a healthy patent regime is entwined with standards of safety & efficacy and is threatened by the proposals to weaken patent rules that are currently before IGWG.

Last summer, Bright Simons wrote an article that examines the relationship between patents and drug safety and efficacy.  According to Simmons:

Without clear patents and robust licensing regulations, the incentive to enforce standards disappears. Patents need not be owned solely by individuals or firms. They may also be owned by communities. But whoever owns these patents would be able to license them for revenue, and will therefore be much greater disposed toward ensuring adherence to standards by licensees. Without patents governments are likely to be solely responsible for enforcing standards. A licensing regime brings in more self-interested brand managers and intellectual property trustees. Hence, the efficacy of standards and the health of any patent regime are intimately intertwined.

Recent events in the East African country of Ethiopia illustrate this principle very well. Late last year, the country’s health and safety watchdog (DACA) withdrew the licenses of some 60 pharmacies representing Indian generic drug manufacturers. The action was prompted by the outcome of a series of working tours conducted by DACA personnel in India during which extensive evidence was uncovered that showed a high rate of negligence among some India drug makers in complying with internationally recognized standards of drug manufacturing. In many cases, the medicines that some of these companies were busily marketing to Ethiopians through local intermediaries had never passed any well-supervised clinical trial. There were even instances of outright fraud in which some of the drugs sent to Ethiopia from India were misrepresented as other, more standards-compliant, drugs. The Ethiopian authorities felt that they had no choice than to bar the entry of many Indian generics in order to protect the health and well-being of the Ethiopian people.

It follows without need for much argument that if standards suffer due to the absence of robust patent regimes, commercial prospects are similarly undermined. This is a piece of common knowledge not amiss anywhere, not even in India, the home in Asia of the patent-busting movement.