DRAFT RESOLUTION ON THE RIGHT TO MEDICINES

DRAFT RESOLUTION ON THE RIGHT TO MEDICINES

The African Commission on Human and Peoples’ Rights,

Preamble

Reaffirming that the African Charter on Human and Peoples’ Rights guarantees that every individual shall have the right to enjoy the best attainable state of physical and mental health and as such, States are obliged to take the necessary measures to protect the health of individuals and ensure they have access to medical care when they are sick, under Article 16.

Noting that the African Charter on Human and Peoples’ Rights entitles every human being with the respect for his or her life and personal integrity under Article 4, and that the right to life is a fundamental human right, whose full enjoyment is a pre-requisite for the enjoyment of the right to health;

Considering the legal instruments of the Commission expanding upon the rights to health and life, including the African Charter on the Rights and Welfare of the Child, the Pretoria Declaration on Economic, Social and Cultural Rights in Africa, the Protocol to the African Charter on Human and People’s Rights on the Rights of Women in Africa, the OAU Convention Governing the Specific Aspects of Refugee Problems in Africa, and the Constitutive Act of the African Union;

Recalling the commitments made by African States at the Abuja Call for Accelerated Action Towards Universal Access to HIV and AIDS, Tuberculosis and Malaria Services in Africa; the Brazzaville Commitment on Scaling Up Towards Universal Access to HIV and AIDS Prevention, Treatment, Care and Support in Africa; and the Maseru Declaration on HIV/AIDS;

Considering international human rights instruments that enshrine the rights to health and life, including the Universal Declaration of Human Rights; the International Covenant on Economic, Social and Cultural Rights; International Covenant on Civil and Political Rights; the Convention for the Elimination of All Forms of Discrimination Against Women; the U.N. General Assembly’s Declaration of Commitment to HIV/AIDS; and the United Nations (U.N.) Commission on Human Rights Resolution on Access to Medication in the context of Pandemics such as HIV/AIDS;

Drawing inspiration from other regional human rights instruments that also enshrine the rights to health and life, including the American Declaration of the Rights and Duties of Man; the American Convention on Human Rights; the Additional Protocol to the American Convention on Human Rights in the Area of Economic, Social, and Cultural Rights “Protocol of San Salvador,” the European Convention for the Protection of Human Rights and Fundamental Freedoms;

Recognizing that members of the World Trade Organization (WTO) may implement global intellectual rules in a manner consistent with the rights to health and life;

Welcoming the decision of the World Health Organization (WHO) Intergovernmental Working Group to explore alternative research and development systems that focus resources on the most needed health problems;

Findings

Alarmed that, according to the WHO, an estimated 10.7 million people died in Africa from communicable diseases, non-communicable diseases, and injuries in 2002;

Recognizing further that half of the population in the poorest parts of Africa lack access to medicines to prevent and treat disease;

Deeply concerned that essential medicines were available in only 38% of all public and private health care facilities in Africa between 2001 and 2007;

Considering that marginalized populations, particularly refugees, women, children, the elderly, persons with disabilities, incarcerated persons, members of rural communities, migrant workers, sex workers, and sexual minorities, bear a disproportionate burden of the lack of access to medicines, which significantly exacerbates their vulnerability;

Reaffirming that the Millennium Development Goals of working together with pharmaceutical companies to provide access to affordable essential drugs in developing countries, improving maternal and child health, and halting and beginning to reverse the spread of HIV/AIDS, malaria and other major diseases by 2015 depends on the improvement of access to medicines;

Welcoming the commitment of African heads of State at the Abuja Special Summit in April 2001 to allocate at least 15% of their national budgets for improvement of the health sector to help address the HIV/AIDS pandemic;

Recalling also the marked improvements of developing countries in Africa and around the world, in reversing the spread of infectious diseases through a display of political will and effective implementation and monitoring of sound prevention and treatment programs;

Recognizing that intellectual property norms being globalized through the WTO Agreement on Trade Related Aspects of Intellectual Property (TRIPS), bilateral trade agreements and other means are contributing to (1) higher prices and reduced supplies of many needed medicines that are under patent in an increasing number of countries, including in countries that have historically provided affordable supplies of medicines to the developing world, and (2) a concentration of research and development expenditures on “profitable” diseases that affect major population in richer countries, compounding the problems with developing new treatments for so-called “neglected diseases” that predominantly affect poor people;

Recognizing that the WHO has explained that promoting access to medicines requires a holistic programme of action, including to promote the rational selection and use of medicines, affordable prices, sustainable financing and reliable health and supply systems;

Recognizing that in development countries a lack of affordability of medicines can be a particularly insurmountable barrier to access because substantial populations rely exclusively on private financing of medicines;

Access to Medicines as a Human Right

Recognizing that the duty to progressively realize the right to health imposes “an obligation to move as expeditiously and effectively as possible” towards its full realization;

Stressing that the right to health is not confined to the right to health care, but rather, embraces a wide range of socio-economic factors that promote conditions in which people can lead a healthy life, and extends to the underlying determinants of health, such as the access to medicines;

Recalling that the U.N. Commission on Human Rights has explained that “access to medication in the context of pandemics, such as HIV/AIDS, is one fundamental element for achieving progressively the full realization of the right of everyone to the enjoyment of the highest attainable standard of physical and mental health;”

Recognizing that the equitable access to essential medical products, vaccines and technologies of assured quality, safety, efficacy, affordability, and their scientifically sound and cost-effective use are essential to achieving the highest attainable standard of health;

Recognizing that the right to enjoy the benefits of scientific progress and its applications requires access to medicines;

Recognizing that access to medicines constitutes an integral part of living a dignified life and that the denial or withholding by a State of medicines essential to protecting or prolonging life poses a threat to the right to life;

Recognizing that the U.N. Commission on Human Rights has stated emphatically that “access to essential medicines is a human right.”

Affirms that the African Charter recognizes a specific right to access to needed medicines that is integral to the realization of the rights to health and to life;

State obligations

Calls Upon States to adopt policies that progressively realize the right to access to medicines, in accordance with international, regional, and domestic law, by ensuring:

1. The availability in sufficient quantities of medicines and medical technologies needed to promote the highest attainable level of health for all in society. This duty includes measures to make currently existing medicines available within their borders as well as to invest in research and development systems to help create new medicines needed to address health problems that are currently neglected by the dominant systems of incentives for innovation;
   
   
2. The accessibility of needed drugs to everyone within the jurisdiction of the state party without discrimination. Accessibility has four components:
   
   
   1. Non-discrimination in access to medicines;
      
      
   2. Physical accessibility of needed medicines within the reach of all marginalized sections of the population, including people living in rural areas, people with disabilities and others who are not able to access transportation, people in the custody of the government or housed in refugee or transitional housing for displaced people;
      
      
   3. Economic accessibility (affordability) of medicines to all such that payment and pricing systems, including systems of public or private insurance, are based on the principle of equity pricing so that poorer or more needy households are not disproportionately burdened with medicine expenses;
      
      
   4. Information accessibility, including the right to seek, receive and impart truthful and accurate information about the availability and efficacy of medicines, and to regulate the dissemination of untruthful, biased and inaccurate information that misrepresents the availability of efficacy of information in a manner that may harm individuals and public health systems.
   
   
   
3. The acceptability of medicines supplies in the country, being respectful of medical ethics and the cultures of populations being served;
   
   
4. The quality of medicines used, including that all medicines be proved to be scientifically and medically appropriate and of good quality before being administered to individuals.

Recognizing that in order to achieve these goals, states must identify good practices for the operationalization of the right to health, and thus the right to access to medicines, at the community, national and international levels by accepting and carrying out their human rights obligations:

1. To respect the right to access medicines by refraining from adopting measures that would deny or limit the access of all persons to preventive, curative or palliative medicines and medical technologies used to treat disease;
   
   
   1. States must refrain from denying or limiting equal access to medicines for marginalized individuals in society, including but not limited to prisoners or detainees, minorities, asylum seekers, undocumented immigrants, institutionalized persons, women, sexual minorities, sex workers;
      
      
   2. States must refrain from prohibiting or impeding the use of traditional medicines and healing practices that are scientifically sound and medically appropriate;
      
      
   3. States may not interfere with the provision of humanitarian aid that facilitates the proliferation of necessary medicine during natural disasters or other national emergencies;
      
      
   4. States must not enter into trade or other international agreements the foreseeable result of which will be to raise prices of and reduce access to needed medicines in society, including agreements that impose “TRIPS-plus” intellectual property rules that may restrict access to generic medicines;
      
   
   
2. To protect the right to access medicines by adopting legislation and/or other measures that preserve access to preventive, curative or palliative medicines and medical technologies used to treat infectious diseases and by ensuring that third parties do not obstruct the enjoyment of the right to health,
   
   
   
   1. States must put in place and enforce legal and regulatory frameworks that prevent third parties from limiting access to medicines through irrational pricing policies, the distribution of unsafe medicines, the spreading of untruthful or misleading information about medicines and other practices that threaten rights to access the best available medicines for their needs;
      
      
   2. States must promote the use of medicines according to the best available evidence through the establishment and regular review and updating of minimum treatment guidelines by professional bodies that are free of any undue influence by third parties, such as pharmaceutical marketers;
      
      
   3. States have a duty to prevent unreasonably high costs for access to needed medicines;
      
      
   4. States must ensure that privatization of the health sector and trade agreements to which the State commits do not constitute a threat to the availability, accessibility, acceptability and quality of health facilities, goods and services;
      
      
   5. States must ensure that medical practitioners and those selling, advertising or distributing medicines meet appropriate standards of education, skill and ethical codes of conduct, including by ensuring that information about medicines is based on the best available evidence and is free of biased, untruthful or misleading information and is not tainted by gifts, payments, kick backs or other practices that may give marketers an undue and corrupting influence over those in the health system responsible for administering medicines;
      
   
   
3. To fulfill the right to access medicines by adopting all necessary and appropriate positive measures to the maximum of its available resources, and by promoting, providing, and facilitating effective access to preventive, curative or palliative medicines and medical technologies, with the necessary regulation and enforcement to ensure their safety, efficacy, and quality;
   
   
   
   1. States must immediately meet the minimum core obligations of ensuring the universal availability and affordability throughout the country and to every person or group of essential medicines, as defined by the country’s essential medicines list and the WHO Action Programme on Essential Drugs;
      
      
   2. States must prevent the unreasonably high costs for access to essential medicines, which can be accomplished through the exchange of price information, price competition and price negotiation with public procurement and insurance schemes, price controls, reduced duties and taxes and improved distribution efficiency, reduced distribution and dispensing costs, and reduced marketing expenses;
      
      
   3. States must discharge their immediate obligations of creating a national public health strategy and plan of action for the progressive realization of the right to access medicines so that access steadily increases;
      
      
   4. States must develop monitoring systems, indicators and benchmarks to ensure compliance with its (1) immediate obligations to make essential drugs universally available now, and (2) progressive obligations to improve access to a broadened definition of needed medicines over time,;
      
      
   5. States must promote and ensure access to information regarding the administration of medicines to allow public health professionals to make informed decisions;
      
      
   6. States must promote meaningful participation, including through access to information and resources to participate through knowledgeable representatives, by affected individuals and groups in decisions that affect access to medicines, including in drug regulatory decisions, decisions to grant or revoke patents on pharmaceuticals and in medicine price decision-making processes;
      
      
   7. States must take advantage of the operational flexibilities built into the TRIPS Agreement in order to promote and protect the right to access medicines, such as the incorporation of compulsory licenses, the facilitation of parallel imports, the promotion of relaxing import duties, and establishing reasonable pricing norms for medicines where available and applicable to ensure the availability of medicines and technologies at affordable prices for treatment, care, and prevention of epidemic, endemic, occupational and other diseases;
      
      
   8. States must use utilize their law making, interpretation and implementation powers to promote the right to access to medicines, including by interpreting ambiguous provisions in trade agreements, competition, intellectual property and other laws to promote the right to access needed medicines;
      
      
   9. States must, individually and together with other developed and developing countries, work to design and implement research and development programmes and systems that ensure that needed medicines are developed to address diseases and conditions that are neglected by traditional patent-based incentive systems;
      
      
   10. States must actively promote and facilitate innovation, research, and development of new medicines and medical technologies through, including but not limited to providing direct funding for the promotion of public research, providing incentives to the private sector through tax credits, patents, or other mechanisms that reward innovation, and encouraging technology transfer between developed and developing countries.
       

Involvement of other entities

Charges the Working Group on Economic, Social and Cultural Rights with the responsibility of defining state obligations related to the right to access medicines within its principles and guidelines;

Calls upon the Working Group on Economic, Social and Cultural Rights to adopt within its principles and guidelines a mandate to investigate, monitor, and implement access to medicines in state parties to the African Charter;

Delegates to the Working Group on Economic, Social and Cultural Rights the responsibility to establish structural, process and outcome indicators for monitoring and assessing the right to access to needed medicines in each member State of the African Union;

Requests the African Union to provide the Working Group on Economic and Social Rights with all the support and assistance necessary to implement this mandate;

Calls upon civil society to transmit reports on violations of the right to medicines and impediments in achieving this mandate;

Conclusion

Notes from Congressional Hearing on Bayh-Dole Act

This is the first posting of a test blog for PIJIP, the Program on Information Justice and Intellectual Property and the American University Washington College of Law. It is sort of a test-run. The blog will focus on IP, human rights, social justice, and access to the products of innovation.

----------------------------------------------

Yesterday, I went to a hearing on the Bayh-Dole Act at the House Science and Technology Committee's Subcommittee on Technology and Innovation. The Chairman's press release about the hearing is here: http://science.house.gov/press/PRArticle.aspx?NewsID=1924

My notes on the hearing are below.

-Mike Palmedo

“Bayh-Dole: The Next 25 Years”

July 17^, 2007 hearing before the House Committee on Science and Technology, Subcommittee on Technology and Innovation

The Subcommittee Chair, David Wu (D-OR) and the Ranking Minority Member Phil Gingrey (R-GA), were the only Members present. David Wu has a science and technology background, seems very interested in Tech Transfer, and said repeatedly that he wants to hold more hearings on tech transfer.

The witnesses were:

· Arundeep Pradham, Oregon Health & Science University. [Where gleevec was invented, partially with government funds.]

· Susan Butts, Dow Chemical.

· Wayne Johnson, Hewlett-Packard.

· Mark Lemley, Stanford.

· Mark Allen, Georgia Tech.

Chairman Wu opened by praising the Bayh-Dole Act, which he says has led to great leaps in innovation. When we was a tech lawyer in Silicon Valley (and Oregon) in the late 1970s, everyone was afraid that the US was losing its edge, esp. to Germans and the Japanese, but since the Bayh-Dole Act has gone into effect, out technology-driven economy has taken off. The key questions to keep in mind are:

• What’s the current impact of Bayh-Dole on commercialization?
• To what extend are US firms turning to overseas universities for research collaboration? To what extent are foreign firms turning to US universities for research collaboration? How does the Bayh-Dole Act fit in to the current situation?
• How can we improve technology transfer for the next 25 year?

Ranking Minority Member Gingrey also opened by praising the Bayh-Dole Act, which the Economist magazine says is the most inspired piece of legislation in the second half of the 20^th century. Prior to the Bayh-Dole Act, only 5% of ugovernment patents were ever used in the private sector. Since the Bayh-Dole Act, this number has increased tenfold.

The law must be able to meet 21^st century needs, which may be evolving as companies are starting to internationalize global research. And also according to the Economist, every one dollar of university research must be matched by $10,000 of private funds in order for a product to be brought to market.

Arundeep Prahham said the law is still instrumental in driving innovation in the US. Its responsible for the existence of 5,000 companies that bring 1.2 products to market a day. The Biotechnology Industry Organization has identified over 350 drugs (some approved, some still in the pipeline) that the Bayh-Dole Act is responsible for. A positive but unexpected consequence is further investment by states – the Oregon Innovation Council, for instance, is active in many research areas including nanotechnology and drug development.

Differences that come up between universities and companies usually involve tensions between the right for scientists to publish their work and the right of companies to protect intellectual property. This is not a result of the Bayh-Dole Act, but a result of the fact that universities and businesses have different cultures.

The Bayh-Dole Act works in its current form and “should not be substantially altered.” If anything, the act should be strengthened, for instance, by increasing oversight of tech transfer among government agencies.

Susan Butts (Dow Chemical) was not as enthusiastic about Bayh-Dole as the others, saying that while the law allows licensing, it also sets expectations for the firms that engage in research partnerships. In other countries, the businesses are granted stronger intellectual property rights when they partner with universities, so businesses prefer to invest abroad. The Bayh-Dole Act is frequently misapplied to research that is privately funded by companies, not government funded at the university. Bottom line: business need more control.

It is important to realize that industries affected by the Bayh-Dole Act differ considerably. The pharmaceutical and chemical industries depend on IP to protect pipeline products for a long time, while the information technology sector moves much more rapidly.

Wayne Johnson (HP) says the information technology sector does not operate with the “homerun” patent in mind. A typical product will be covered by hundreds of small, patented innovations. Cross-licensing is key – everyone in the sector has numerous licenses with their competitors. In this environment, it is frustratingly hard to set up collaborations with American universities. It can take 2 years to set up a university collaboration in the US, or 2 days to set one up in Russia.

The future of successful innovation, though, requires collaboration. Intellectual property rules should not be changed just because a business is collaborating with a university. IP protection is still important, and there should be a uniform approach to ownership.

The future focus should be centered on innovation, not licensing.

Mark Lemley (Stanford) begins by pointing out that universities are now granted 16 times as many patents as they were before the Bayh-Dole Act, and they earn billions in licensing. The Bayh-Dole act has addressed the problem of unused IP – there used to be a lot of uncommercialized innovation.

The problem with the Bayh-Dole act is that universities are often too quick to cash in by licensing their inventions immediately, instead of seeking to advance learning in the best way. Universities should seek to maximize the public good. Depending on the situation, this could be done by granting an exclusive license, granting a non-exclusive license (for instance, for intermediate scientific advances, monoclonal antibodies), or by giving up patent rights in the first place.

There’s a widely different view of the Bayh-Dole Act between industries. The need for the law is greatest in medical technologies and weakest for information technologies.

The government should use its March In rights when it is necessary for the public good.

Mark Allen (GA Tech) said his invention was patented by GA Tech, then licensed to the Department of Defense. It is now used by NASA. Later, it was realized it could have a medical use as well, so he started a medical company, and developed a product. The ratio of private to public spending on the commercialization of his medical product was 100 to 1. (not 10,000 to 1) He view Bayh-Dole as a great success and notes that other nations are copying it.

Q&A

Wu: The views of the success of BD not shared by everyone. Where are there problems and where are there not?

Pradhan: There’s more collaboration between universities and business now than ever before. In the last 3 years, collaborations involving OHSU have doubled, including much in the clinical development of new drugs. IP itself is not a stumbling block.

Butts: The growth in the number of partnerships is a coincidence, and it is not only happening in the US, it is worldwide, including countries with no equivalent to BD. In negotiations, both the businesses and the universities are trying to do what’s right for themselves. Development timelines in each of the sectors is very different.

Johnson: The IT sector is much different than others. We license our technologies to our own competitors, our cost per unit keeps falling, and the time from development to market can be three months. Since IT is global, we seek opportunities everywhere, looking to get work done rapidly. Also, globalization of research is not necessarily a bad thing.

Lemley: Not all patents are “homeruns,” or really successful ones. Problems arise when universities try to treat smaller, less significant patents like “homerun” patents.

Allen: Universities and businesses need to learn their roles and the roles of patents.

Gingrey: Should Congress seek different tech transfer policies for different industries?

Lemley: Maybe, but only as a last resort. Its better to solve these problems at the university level. (Allen and Pradhan agree.)

Butts: Agrees, but would like to see more flexibility in the system that would allow businesses and universities to reach mutually beneficial terms.

Johnson: There’s already flexibility in BD, but real world negotiations always start with one side demanding exclusive rights. This slows the negotiations. Often , negotiators don’t see the big picture. In the California school system, they’ve kicked negotiations upstream to the provosts, and this seems to have worked. Provosts get the big picture better than lawyers/negotiators from Tech transfer offices.

Wu: What do successful universities do differently?

Johnson: They hire excellent staff, and they understand the strategic, long-term relationship between the school and the company.

Butts: Universities are comfortable offering us the option of getting an exclusive license, which is not enough. We’ve already invested heavily and can’t take the uncertainty.

Lemley: There is a big problem of structures and incentives. If a tech transfer office is judged by how much cash it raises, then that’s what it will focus on.

Gingrey: Basically same question about what do successful schools do well. What does Georgia Tech do right?

Allen: You need long relationships with companies that are based on a broad spectrum o scientific expertise, including applied science. You need a sense among the faculty that tech transfer is part of the role of the university – not that revenue from licensing is a main driver of revenue for the university.

Butts: GA Tech realizes the importance of quickly commercializing research.

Wu: What kind of oversight could help tech transfer?

Allen: Trade associations may be able to fulfill an oversight role. Concern about reputation (not the strong arm of the government) may motivate universities and businesses.

Lemley: March In rights are important in theory, though they have never been used. They keep a threat hanging over the heads of both inventors and companies. Unfortunately, there has been timidity among government agencies afraid of being the first to use March In rights.

Wu: Would government guidelines be helpful?

Butts: Problems don’t come up when we license federal research. Problems come up with intellectual property. BD should not apply in situations where businesses are paying for most of the research.

Pradhan: Its not the role of Congress to determine what happens when universities and businesses collaborate.

Gingrey: When the federal government sponsors university research and a homerun occurs, how do taxpayers get reimbursed for their investment?

Pradhan: Every academic invention need substantial investments. When a university does hit a homerun, most of the funds it receives are pumped back into further research.

Butts: Consumers gain from access to new products that would not exist without the business-university collaboration.

Johnson: The university/company collaborations create a lot of jobs.

Lemley: All of the other answers people have given, but only if alternatives are product or no product. This is why the March In rights are important.

Wu: What can be done do make universities focus on the big picture for Tech Transfer?

Lemley: There should be best practices benchmarks set up by universities. Also, the more isolated a tech transfer office is from the rest of the university, the more likely it will have a short-term focus. Definitely discourage the outsourcing of tech transfer.

Johnson: There is a problem of metrics – you get what you measure. This is 90% of the problem with the actual negotiations. People are being judged by the numbers, but the money they raise.

Gingrey: Why do US firms find it easier to negotiate overseas?

Johnson: There are many reasons. Overseas universities are eager to collaborate and compete with other schools. Partnerships move faster.

Butts: Useful inventions that are close to a commercial product are rare. Foreign universities want research partnerships as opposed to patents.

Wu: To what extend is overseas collaboration driven by hunger for research, and to what extent do Non-Tariff Barriers require it?

Butts: NTBs are not a big problem. The products and research that we collaborate with universities on is very far upstream.

Johnson: That comes up sometimes, but not much. However, there is an implicit assumption that companies and universities in some countries will have a working relationship with each other. In Brazil, they give us really good tax breaks when we collaborate with their universities. So we do a lot of collaborations there.

At this point, Chairman Wu stopped the hearing, somewhat abruptly. There were a number of votes that afternoon. Wu promised further hearings on tech transfer.