Access to Treatment in the MENA region10
HIV prevalence in the MENA region remains low, except in Djibouti and southern Sudan (South Sudan). There are concentrated epidemics in Egypt and Sudan among MSM;
in Bahrain, Libya and Oman among injecting drug users, and in Algeria, Morocco and possibly Yemen among sex workers. The trend is one of rising HIV prevalence, rising rates of new HIV infections and rising AIDS-related deaths.
Access to treatment is an essential component of the right to health. Coverage of health sector interventions is influenced by availability of services and demand. In 2009, the MENA region had an ARV coverage level of around
12%, the lowest in comparison to other regions of the globe. Coverage of ARV drugs is particularly low in Sudan (South Sudan), Somalia and Egypt. There is diversity within the region, with some countries such as Tunisia enjoying ARV coverage levels of greater than 50% and Oman of more than 90%.
In theory, ARVs are affordable – almost all MENA countries provide ARVs for free. However, obstacles to treatment access include discriminatory laws and practices, centralization and control of distribution and interruptions to supply due to procurement issues, policies on prices, and patent laws.
Demand for ARVs is influenced by uptake of HIV testing and timely introduction of ARVs, monitoring and follow-up. HIV testing and counseling services are expanding and improving, and there is more civil society engagement in testing programs allowing outreach to most-at-risk populations. Factors that need to be addressed to ensure optimal levels of demand for ARVs include:
1. Reducing stigma and discrimination by changing attitudes and raising awareness;
2. Addressing barriers created by criminalization that prevent outreach services reaching hidden populations;
3. Ensuring laws and ethical standards prevent breaches of confidentiality; and 4. Ensuring that prevention programs are targeted and well designed.
The number of HIV testing and counseling facilities is inadequate given the population size.
There are gaps between HIV testing efforts and the identification of cases. For example, a disproportionate number of tests are done on migrants. A recent study showed that although migrants represent only 15% of positive results, 60% of tests are done on migrants.
10 Dr. Ragia Elgerzawy, Egyptian Initiative for Personal Rights.
“If one person needs treatment, she has a right to be treated, even if she is the only person in the country.”
Renata Camile Reis, Brazilian Interdisciplinary AIDS Association, ABIA.
Mandatory testing is the most prevalent approach. This violates rights to privacy and bodily integrity.
Poor monitoring of new diagnoses can result in delay between clinical eligibility for ARVs and the initiation of treatment. Lack of information and fragmentation of health care services can lead to late initiation of treatment.
For example, in Egypt HIV services are not well integrated into the broader health care system. Fever hospitals are the only public hospitals that attend to people living with HIV.
There is no systematic follow-up of patients for drug adherence or resistance. There is a lack of clinicians with experience in HIV medicine. Laboratory services are limited. CD4 tests are only available in two places, and viral load tests are only available for children.
Adherence to ARV regimens and patient retention levels provide a good indication of efficiency and effectiveness of treatment. Twelve month ARV retention rates vary across the region: Egypt 75%; Djibouti 74%; Yemen 93%; Algeria 97%; Lebanon 20%.
Improvements in treatment access have beneficial affects on quality of life, prevention of HIV transmission and reduction of illness, deaths and the associated cost burdens on the health system.
Treatment failure is an emerging problem caused by a combination of factors: insufficient knowledge among patients and health care workers, sub-optimal adherence to drug regimens, drug stock-outs, and inadequate patient monitoring mechanisms. When first-line treatments fail, patients need to be able to access second-line treatment regimens, which are at least six times more expensive.
Recommendations:
1. Adoption of high quality medical standards consistent with the World Health Organization’s recommendations relating to full and continuous access to care, patient follow-up and adherence monitoring, proper selection and prescription of drugs, community–based health care approaches and continuity of ARV drug supplies.
2. Raising awareness about human rights and legal rights.
a. Improvements in access to justice for people living with HIV and most-at-risk populations;
b. Challenging police misconduct and improper law enforcement practices;
c. Strategic litigation in cases of discrimination;
d. Redress and compensation for victims of discrimination; and e. The effect of intellectual property rights on drug prices.
Access to treatment: Latin America11
Latin America has ARV coverage levels of over 50%, which is higher than most low and middle-income countries globally.
In the Venezuelan case of Cruz Bermúdez et al. v. Ministerio de Sanidad y Asistencia Social (1999) an action was filed against the Health and Assistance Ministry due to its refusal to
11 Ms. Renata Reis, Brazilian Interdisciplinary AIDS Association (ABIA).
provide HIV treatments. The claim alleged violation of rights to life, health, personal freedom and security, and denial of the benefits of science and technology. The Constitutional Court ordered the Ministry to supply the applicants with ARVs, as well as any drugs needed to treat opportunistic illnesses. The Constitutional Court also ordered that the President of Venezuela adjust the budgetary allocation for HIV to pay for treatments.
In the Peruvian case of Azanca Alhelí Meza García (2004) a person living with HIV lodged a claim against the Ministry of Health requesting full medical care, including permanent supply of drugs, CD4 tests and viral load tests. This case is a key precedent for the enforceability of social rights in Peru. The Court ordered that action be taken to ensure the realization of the right to health regardless of the limited financial resources initially assigned to the sector.
A petition was filed against El Salvador in the Inter-American Commission on Human Rights alleging violation of the rights to life, health and full development of personality of a group of people living with HIV, in 2001. The case was grounded on the state's failure to provide ARVs. The Commission declared the case admissible and made recommendations. The parties are still trying to reach an agreement on how to comply with the Commission’s recommendations.
Between 2000 and 2002, the Inter-American Commission on Human Rights granted precautionary measures on behalf of over 400 people living with HIV in OAS Member States (Bolivia, Chile, Colombia, Dominican Republic, Ecuador, El Salvador, Guatemala, Honduras and Peru). In most cases the Commission requested the State to provide the beneficiaries with the ‘treatment indispensable for their survival’.
In Brazil, advocacy has focused on the impact of the Agreement on Trade-Related Aspects of Intellectual Property Rights (TRIPS). TRIPS established minimum standards for protection of intellectual property rights that World Trade Organization member states were required to comply with from 2005. TRIPS allows states to legislate for flexibilities such as compulsory licensing to enable drugs to be made available to address public health priorities, but flexibilities have proved difficult to implement in practice. For example, Paraguay includes all flexibilities in its patent law but has not applied these flexibilities in practice. Governments are often reluctant to implement flexibilities because of pressure from the USA and the large drug companies not to use TRIPS flexibilities.
The Working Group on Intellectual Property (GTPI) of the Brazilian Network for the Integration of Peoples has been formed to focus on legal suits, advocacy, opinions on bills, capacity building, media appearances and publications. GTPI has been involved in six patent challenges, working preemptively to address weak patent applications (e.g. patent applications for drugs that are produced by very minor or superficial changes to an existing drug). Three pre-grant oppositions have been successful (in relation to Kaletra and Tenofovir). A pre-grant opposition in relation to Truvada is awaiting examination.
Experience has demonstrated that use of pre-grant opposition processes to prevent patents being issued can produce fast and positive results.
Two court cases are pending in Brazil. One relates to a civil action for a license to issue Kaletra, which is awaiting an appeal judgment. The initial trial in relation to Kaletra appears to have been unsuccessful in 2010 due to fear of retaliation from the USA, rather than legal grounds. The other case awaiting judgment relates to a petition to the Prosecutor General claiming that laws relating to 'pipeline' patents are unconstitutional. Over 1,100 pipeline
patents were requested in Brazil under provisions that enabled firms to apply for patents simply on the basis that a patent already existed that had been granted by another country.
The international Medicines Patent Pool has signed a licensing agreement with the drug company Gilead in relation to four ARVs. Many middle-income countries are excluded from the Patent Pool deal for Gilead’s ARV drugs, including Argentina, Brazil, Chile, Colombia, Paraguay, Peru, Uruguay, Venezuela, Costa Rica, Mexico and Panama.
Challenges that we face include: financing of litigation; courts are often unprepared to judge patent issues due to corruption or political pressure; and the need for training of lawyers on intellectual property and other monopoly practices (including competition law).
Discussion: Access to treatment
There is a correlation between countries that lack democracy and low levels of treatment access because people are not equipped to demand their rights. The democratic deficit has health consequences. Citizens need to understand that treatment access is a right, rather than an act of charity. The starting point is awareness raising that access to treatment is a human right, understood in terms of the rights to health, to life and to non-discrimination.
In many countries, (e.g. Colombia) there is no political will to break patents. In Mexico, despite the provision of health insurance by the state, bureaucratic obstacles have led to interruptions in the supply of ARVs. Class actions may be necessary against drug companies or governments to ensure treatment access.
It is difficult for treatment activists in Brazil to access medical expertise. The Brazilian Interdisciplinary AIDS Association (ABIA) has the technical support of one pharmacist who works for Médecins Sans Frontières. Universities and research centers are wary of supporting activist lawyers because they rely on private sector financial contributions. There has been success in South-South cooperation between Brazil and India on some patent oppositions.
In South Africa, the Treatment Action Campaign (TAC) focused on treatment literacy at the community level at a time when the nation’s President denied that HIV causes AIDS.
Community mobilization and advocacy forced the government to draft a national HIV treatment plan. Although this was successful, some populations were omitted from the plan.
TAC had to work with public interest lawyers (Section 27) to mount litigation to confirm the right of prisoners to access treatments. TAC uses all available means, including demonstrations and the media, working through lawyers, NGOs and activists, to pressure government departments in health, finance, trade and industry to work together to improve treatment and care. HIV has enabled us to identify flaws within South Africa’s overall health system. The government has been pressured to produce a plan for the health system as a whole, including building health centers closer to communities and addressing shortages of health care workers. South Africa is moving towards a national health insurance model.
Similarly, ARASA has learnt the importance of combining bottom up and top down approaches. ARASA promotes treatment and rights literacy at the community level so that there is demand for the right to health, and also targets governments through advocacy at national, regional and global levels. ARASA is increasingly focusing on a broad health agenda, such as advocating for a global framework convention on the right to health. This
broader advocacy agenda requires alliances to be forged with health activists, trade unions and civil movements beyond HIV.
In Zimbabwe, 600,000 people lack treatment access but arguments based on the right to health have limitations because courts will not instruct the executive arm of government where to allocate resources.
A current issue threatening treatment access is the introduction of new European anti-counterfeiting laws, allowing generic drugs to be confiscated and destroyed in Europe prior to delivery to Africa or Latin America. Drug companies and governments are both responsible for these laws. Access to generic drugs may be reduced as a result of the anti-counterfeiting provisions of trade agreements.
The MENA countries lack drug manufacturing capacity so rely on ARV imports, but the level of demand for ARVs is small and there is little negotiating power to reduce prices. Local production capacity is important but not essential, as compulsory licenses can in theory be used to import drugs if governments have the political will. For the MENA region, it may be more important to negotiate lower prices if it is politically unrealistic to break patents. There may be a need for a different approach compared to high HIV prevalence countries.
In the Middle East, migrant workers who are compulsorily tested for HIV have no rights to treatment and are deported. The issues of travel restrictions and treatment rights overlap.
Governments need to strengthen resolve to exercise TRIPS flexibilities. It is not only the drug companies who are responsible. Pricing policies vary in each country. Some wealthy countries such as Spain have cheaper ARVs than Egypt because of pricing regulations. Price reductions can be achieved by working through a common purchase market. Negotiations with drug companies for voluntary licenses have been successful for second and third-line ARVs. For countries with less demand it may be possible to work with regional organizations to find joint solutions so low HIV prevalence countries are not penalized.
In the Southern USA states such as Mississippi, there is a lack of infectious disease specialists, especially in rural areas. The system in place in Mississippi requires Disease Intervention Specialists to identify and notify sexual partners of individuals who test positive for HIV. Mississippi limits Medicaid beneficiaries to five prescription drugs a month, which may not cover all of a persons HIV prescription drug needs. Federal drug assistance relies on state contributions. Conservative states do not invest in drugs so there are long waiting lists.
IDLO and UNDP training on patents and access to medicines in Nepal in April 2011 resulted in recommendations to inform amendments to proposed intellectual property legislation.
In Egypt, Justice and Freedom has held several meetings with the PLHIV to help them write and finalize a document on their rights to have proper access to medicines. The document notes issues related to improper medications and healthcare in general for PLHIV. Violations of patient rights perpetrated by government hospitals have also been documented, and these reports have been presented to the government. The next step will be to refer cases to the judiciary and prosecutors regarding allegations of corruption and misallocation of funds.