WSJ opinion – Africa’s Health Crisis

An interesting opinion from the Wall Street Journal about challenges and barriers to improving public health in Africa.

How to Worsen Africa’s Health Crisis: Killing off drug patents will kill off innovation and patients.

By ALEC VAN GELDER

Faced with Africa’s devastation by HIV/AIDS, people are looking for scapegoats. Global pressure groups and now the World Health Organization are targeting “Big Pharma.” The drug companies do make easy targets but that doesn’t make them villains. The life-saving treatments they create remain Africa’s best hope. The misguided battle against pharmaceutical companies’ patent rights will only make Africa’s health crisis worse.

Intellectual property rights for AIDS drugs are “the biggest public health challenge” as they make them too costly for most Africans, Hans Hogerzeil, head of the WHO’s Essential Medicines program, recently said. They are “a barrier to access,” he previously claimed, but the real barriers are the lack of infrastructure and the diversion of aid money. Fewer than 5% of WHO’s 423 Essential Medicines are currently protected by patents; mostly advanced “second-line” anti-AIDS medicines.

Ethics, research and NGOs

The Global Bioethics Blog recently added a very interesting post about the ethical challenges faced by humanitarian organizations in conducting research, with a specific focus on MSF.  The following is an abbreviated version of the post, though the original is certainly worth reading:

Medecins sans Frontieres (MSF) is a humanitarian organization whose Nobel Prize winning work barely needs an introduction. They are well-known for their efforts in providing health care (among other services) to those in severe social crises and emergencies worldwide. What is less known is that MSF is increasingly conducting its own research among vulnerable communities where it does its humanitarian work.

The ethical challenges <of this dual role> abound: How can consent of participants be voluntary if MSF is doing clinical research and acting as the sole provider of medical care in a certain locale? How can consent be informed when there is a blurring of lines between MSF care and MSF research?

Some sentences in the article left me with the impression that the marriage between MSF and its ethics committee has been unhappy at times. The paper states that the ethical review board is “not accountable for any research which is carried out against its advice,” suggesting that there were cases of non-approved research.  The authors (themselves members of MSF’s ethics review board) indicate that their recommendations have only partly been taken into consideration in MSF’s research policies or procedures.

A bit strange, when you think about it: wouldn’t you expect a humanitarian organization, having decided to do research on vulnerable populations, to be the most aggressively concerned about the protection of research participants?

Not letting the facts get in the way of a weak argument

Ensuring that patients around the world have access to safe and affordable medicines – be they brand name or generic – is an issue worthy of thoughtful global discussion and action.  But that discussion should be honest and forthright and not driven by half-truths and misrepresentation of the facts.

Recently, officials in the Netherlands exercised diligence in safeguarding the integrity of the medicines supply chain within their own country by delaying a shipment of generic drugs until it could be determined if these drugs were legally entering the Netherlands market or whether they were being trans-shipped to another country.

The feigned outrage of Brazilian officials and anti-intellectual property rights activists over this reasonable action by the Netherlands demonstrates the extent to which anti-IP activist will go to manipulate  facts in the absence of sound arguments to support their own biased views.

Here are the facts:

In December of 2008, a small load of generic drugs were shipped from India to Brazil, via the Netherlands.  The drugs are not patented in Brazil or India, however they are patented in the Netherlands.  Therefore, Dutch customs authorities detained the drugs in order to determine if they were destined for the Netherlands .  They did so in conformity with the law.  Once authorities ascertained that the drugs were not destined for the European market, the authorities released the drugs to the original owner (India’s Dr. Reddy Laboratories), again in accordance with the law.

The Netherlands’ authorities did not destroy the drugs.  They did not seize the drugs, nor did they return them to India. 

This event (or non-event) took place at a time when the WHO was convening a meeting to define the term “counterfeit medicines”.

The government of Brazil and anti-IP activists used this meeting to sustain their ongoing attacks on intellectual property rules.  In the absence of any better arguments, they chose to exaggerate this incident out of all proportion to imply that the drug shipment investigated by the Netherlands had been deemed to be “counterfeit” under definitions adopted by the WHO.

Citing the detainment of this shipment of drugs from India, anti-intellectual property blogs denounced the pharmaceutical industry, the Netherlands, the WHO, the TRIPS agreement, and the definition of counterfeit drugs.  Brazilian officials brought the matter to official attention at the recent Executive Board of the World Health Organization.  Officials are even quoted saying that the move is a setback for the internationally guaranteed principle of universal access to medicine, and that this event will set a bad precedent for public health by creating yet another barrier to the delivery of quality, affordable generic drugs to developing countries.

This case has nothing to do with counterfeiting or universal access to safe and affordable medicines and everything to do with furthering a political goal.

Dutch officials got the facts before they took action.  But anti-IP activists refused to let the facts get in the way of their arguments.

Patents are the wrong target

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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