Emergency prescriptions for the Okinawa G8

Médecins Sans Frontières (MSF) welcomes the new efforts for tackling infectious diseases that have followed the Group of Eight (G8) meeting in Okinawa in July. Six months later, the question now arises: where should we focus our energy and resources? What will be the wisest use of public money? The G8 should choose strategies that are sustainable and effective, and that address both short- and long-term needs. On a fundamental level, these strategies should also reaffirm the individual's right to health. The right priority areas have been identified for the Okinawa International Conference on Infectious Disease. HIV/AIDS, tuberculosis and malaria are infectious diseases that impact millions of people and extract a heavy toll on the developing world. However the G8 should also broaden its efforts towards less visible diseases that have been neglected by the market, such as sleeping sickness and leishmaniasis. Support should also extend beyond the least-developed countries and sub-Saharan Africa, to all developing countries that are currently confronting infectious diseases. MSF believes that prevention and treatment are both essential and complementary components of any strategy for fighting a disease. Nevertheless, the following discussions will focus on access to treatment. The strategies outlined below do not aim to be comprehensive, but rather to introduce some of the key tools and principal issues around access to medicines for malaria, TB, and HIV/AIDS. Disease-specific strategies It is recommended that implementation of all of the strategies below begin as soon as possible. The aim is both to address short-term needs and to provide long-term solutions. Malaria: 1. New combination treatments should be introduced immediately. They have been proven effective against resistant strains and can slow the spread of drug-resistance. 2. Operational research needs to be accelerated to increase the existing knowledge on the best practices for applying new combination treatments and diagnostic strategies in resource-poor settings. 3. R&D efforts must be increased for affordable and easy-to-use drugs. MSF supports the goal of the Medicines for Malaria Venture and other research initiatives as part of a long-term R&D strategy. Tuberculosis: 1. The DOTS treatment protocol should be simplified. DOTS is the best available strategy, but is difficult to implement and inadequately addresses multi-drug resistant TB (MDR TB). The increased use of fixed drug combinations and the development of simple, accessible diagnostics can both improve DOTS. 2. DOTS-plus for MDR TB should be improved and expanded. 3. R&D should be accelerated for new TB vaccines and medicines that are easier to use. Research should examine both new molecules and existing drugs that are useful for other indications. The Global Alliance for TB, currently the only initiative that focuses on R&D for new drugs, should be supported. HIV/AIDS: 1. The G8 should prioritise access to care on all levels: palliative care, treatment of opportunistic infections, and anti-retrovirals (ARV) for people living with AIDS. It is unacceptable to leave 95% of infected people with no access to the treatment that can improve their quality of life, prolong survival, and allow them to continue contributing to their families and society. 2. The G8 should assist countries that are ready to begin ARV treatment and/or have low prevalence rates to rapidly begin using ARVs. The ultimate goal should be to offer universal coverage for all people living with AIDS within a particular country. 3. Operational research is needed to simplify and adapt treatment protocols for resource-poor settings. Extensive treatment projects should begin immediately to develop the best practices for using ARVs in high-prevalence and/or least-developed countries. Prescriptions for policies Equity pricing Equity pricing is the policy of reducing drug prices dramatically so that they are truly affordable to the patients who need them. A number of new medicines that are vital for the survival of millions (antibiotics, anti-parasitics, and anti-retrovirals) are too costly for the vast majority of patients living in poor countries. Many of these medicines were developed over the last two decades to respond to the needs of the industrialised world. In more and more countries, they are covered by patents for a minimum of 20 years, blocking the production of less-expensive generic versions. In the past, equity pricing has been successfully implemented for vaccines and oral contraceptives, with drugs costing as much as 200 times less for poor countries. This type of dramatic discounting will require a real political commitment and government action on a global scale. There is a key distinction between equity pricing and currently offered industry price discounts or drug donations. Equity pricing is a sustainable option that gives developing countries a greater degree of autonomy, while the currently offered discounts and donations rely on the impulses of individual companies. Recommendations: 1. The G8 should support a global system of equity pricing to make key medicines affordable to the developing world. Prices should be reduced by at least 20-100 times (i.e. the magnitudes of reduction currently seen with vaccines). The lowest possible prices should be demanded, using marginal cost of production as a guideline. 2. The equity pricing system should incorporate a framework that encourages the participation of originator drug companies. Provisions to prevent import of equity-priced drugs into high-income markets are important. 3. National governments of donor countries should adapt systems of incentives to favour equity pricing over less effective or sustainable policies (e.g. The US tax system currently provides a sizeable incentive for donations). Voluntary licensing and technology transfer Strategies to improve access to medicines should include policies for both transferring technology and granting voluntary licenses to manufacturers of quality generics in developing countries. Technology should be transferred not only to least-developed countries, as is required under TRIPS (article 66.2), but also to the developing countries with the capacity to produce quality drugs. These countries will be the best candidates to start using treatments that are presently out of reach solely because of price. International procurement and funding The G8 should mobilise resources for an international procurement fund for low-priced medicines. While equity pricing will enable mid-level countries to pay for the medicines they need, a procurement fund will still be critical to subsidize drug purchases for the poorest countries. The ability to negotiate affordable prices will depend on the predictability of payment and needed quantities. Under the aegis of the UN, a virtual international procurement fund could leverage the buying power of developing countries. This system would: 1. Improve the predictability of the demand 2. Organise international tenders for bulk purchase 3. Assist in procurement and production planning 4. Offer guaranteed payment In addition, the G8 should support a database of information on drug prices, quality and patent status to increase global price transparency. This will be critical information for guiding the decisions of country purchasers. This database should be managed by a UN agency, with patent information provided by the World Intellectual Property Organisation (WIPO). The database should be easily accessible and updated regularly. Research and development The market has failed - and will continue to fail - to stimulate enough R&D for medicines for the diseases of the poor. Increasing R&D for priority global diseases - such as TB and tropical diseases - cannot happen without government commitment and intervention. Public funds should be allocated to support drug research. Measures must include: 1. Defining priorities for international research 2. Securing the market - when needed - for new drugs 3. Creating a regulatory and fiscal framework that encourages R&D 4. Promoting the idea that new medicines are "public goods." New drugs should benefit the public, and their availability should not be subject solely to market forces. Additional strategies for stimulating R&D need to be developed. MSF proposes a global treaty on funding R&D for diseases that affect the poor. The treaty should correct the imbalance between rights and obligations under the present international treaties and agreements (e.g. TRIPS) and provide new legal options to make drugs for neglected diseases a global public good. Public private partnerships Public sector collaboration with the private sector is needed to overcome the failure of the market in producing drugs for neglected diseases. The ultimate purpose of these public-private partnerships (PPPs) should be to benefit the public good. Therefore, PPPs should always control the intellectual property rights of their end products and insist on strong guarantees for their affordability. The public should demand accountability for any funding or incentives given for R&D in the private sector, to ensure that the money will ultimately benefit the public. Policies should ensure that public funds are not channelled to the commercial sector for private benefit only. PPPs must be governed by a clear set of principles that ensure: 1. Transparency and accountability in decision-making and governance 2. Affordability and accessibility of the end products to those who need them 3. Control over the intellectual property rights to the inventions 4. Collaboration with researchers in developing countries 5. Built-in provisions for technology transfer and support for production in developing countries, where applicable Trade-related issues that affect access to medicines The implementation of the TRIPS agreement will have a negative effect on the developing world's capacity to manufacture affordable generic drugs, and will lead to an increase in drug prices. Nevertheless, the TRIPS agreement includes options to counteract the negative effects of patent protection. To overcome barriers to access caused by intellectual property protection, countries should be supported in using these options. The absence of a strong public health voice in TRIPS implementation has been detrimental. WHO should step up its efforts in defending public health against the increasing dominance of commercial interests over the right to health. 1. The G8 should issue an unequivocal statement that its members will not pursue retribution (either in the WTO or bilaterally) against countries that implement TRIPS-consistent measures in response to health needs. Such measures include compulsory licenses, parallel imports, and steps to accelerate the introduction of generics. 2. The G8 should ask WIPO to draft model legislation, which will help governments to implement laws that are TRIPS-compliant and offer the highest level of protection for public health. Intellectual property rights should be balanced with public health interests.