(Reposted with permission from the TWN Info Service) Developing countries are set to introduce a resolution on access to medicines at the current session of the United Nations Human Rights Council.
The 23rd regular session of the Human Rights Council is taking place from 27 May to 14 June in Geneva and the draft resolution is expected to come up for consideration next week.
Brazil, in its intervention on the “Report of the Special Rapporteur on the right of everyone to the enjoyment of the highest attainable standard of physical and mental health, Anand Grover, on access to medicines” (A/HRC/23/42), stated that developing countries including India, Brazil, South Africa, Egypt and Thailand will introduce the draft resolution at the Council. It will take forward the recommendations of the Special Rapporteur.
It is learned that informal negotiations are already underway. The draft resolution requests States, the UN and other intergovernmental organisations to address the existing challenges with regard to access to medicines in the context of the right to health, and the ways to overcome those challenges.
The report of the Special Rapporteur on access to medicines, which was introduced at the Council meeting on 27 May, “identifies and analyses challenges and good practices with respect to access to medicines in the context of the right-to-health framework”.
It uses the key human rights framework on access to medicines, i. e. availability, accessibility, acceptability and quality to analyse the international and national determinants to access to medicines.
In the first section of the report, the Special Rapporteur reviews the international legal framework as it applies to access to medicines. In the second section, he identifies key determinants of access to medicines and discusses challenges and good practices with respect to each aspect. The key determinants identified in the report are: local production of medicines, price regulations, medicines lists, procurement, distribution, rational and appropriate use and quality of medicines.
The Special Rapporteur clearly states that, “access to affordable and quality medicines and medical care in the event of sickness, as well as the prevention, treatment and control of diseases, are central elements for the enjoyment of the right to health”. Further, he “calls upon States to shift from the dominant market-oriented perspectives on access to medicines towards a right-to-health paradigm in promoting access to medicines”.
According to the report, there are four key measures to be carried out by a State to fulfill its obligation with regard to access to medicines within the right-to-health framework. These are: (i) availability of medicines in sufficient quantities in public health facilities based on list of essential medicines selected to meet the priority health needs of the population; (ii) measures to ensure economic and physical access to the medicines on a non-discriminatory basis; (iii) measures to ensure that medicines that are determined are culturally and ethically acceptable to the people; and (iv) a strong regulatory mechanism coupled with transparent process to ensure quality, safety and efficacy of medicines.
The report urges States to adopt a national health policy with a national plan of action to ensure access to medicines. Further, it encourages States to ensure that national plans should adhere to the “central principles of non-discrimination, transparency, accountability, and multi-stakeholder participation, particularly of affected communities and vulnerable groups.”
The findings and recommendations of the Special Rapporteur on the six determinants of access to medicines contained in the report are as follows:
LOCAL PRODUCTION
The report states that local production is “politically and strategically important for developing countries to ensure the security of access to medicines for their populations through local production”.
It notes the global disparity in the consumption and production of medicines. According to the report, during 2004-08, North America, Europe and Japan accounted for 95 per cent of the medicines sales. It also reveals that 90 per cent of the global production of medicines during the same period was also concentrated in the developed countries.
Calling for a “coherent policy framework that explicitly links local production to improved access to medicines”, the report further suggests the following policy options to countries to create an enabling environment for the local production of pharmaceuticals: (i) levying taxes on imports of medicines that could be locally produced, except for active pharmaceutical ingredients which are generally not imported; (ii) providing subsidies; (iii) tax incentives; (iv) guaranteed government procurement to local manufacturers; and (v) a regulatory framework to increase local competitiveness.
It also highlights the indirect benefits of local production to: (i) promote transfer of technology, (ii) provide employment and capacity-building of local people through training programmes for local pharmacists, microbiologists and technicians, and (iii) set up local institutes of higher education and contributing to capacity-building of the regulatory agencies. It further stresses the need for states to take advantage of the flexibilities under the WTO Agreement on Trade-Related Aspects of Intellectual Property Rights (TRIPS Agreement) and the 2001 Doha Declaration on TRIPS and Public Health.
It makes the following policy measures with regard to long-term security and affordability of medicines through local production: to develop a policy framework on local production of medicines to ensure long-term accessibility and affordability of medicines; to strengthen the regulatory framework to increase the competitiveness of the local industry and provide administrative and financial support, subsidies and guaranteed purchases; to use flexibilities under the TRIPS Agreement to promote regional collaboration to pool resources and facilitate competitiveness of local production.
PRICING
The report states that “affordable and equitable pricing of essential medicines is therefore a key determinant of access to medicines in most developing countries.” It notes that in developing countries, up to two-thirds of expenditure on medicines are out-of-pocket payments. It also finds that the catastrophic payment on medicines is pushing annually “approximately 100 million people, mostly in developing countries, into poverty.” To address the price question, it discusses policy measures in the following areas: price control, mark-ups, tariffs, taxes, manufacturers’ prices and competition law.
The report observes that in developed countries, governments frequently apply price control mechanisms as part of their overall strategy to contain costs primarily due to the substantial coverage of the population through insurance. It notes that in the absence of price control in developing countries with high-income inequality, only rich people can access the medicines. Therefore, the report states: “States that inadequately use price controls to ensure affordability of medicines would fail in their obligation to use all available resources, including regulatory powers, to promote the right to health.”
On mark-ups on medicine prices, the report finds that mark-ups can account for up to 40% of the price of the medicine. Hence, it stresses the need to control the mark-ups in medicine price, and urges “States to assess the impact of distribution mark-up regulations on medicine prices while maintaining the viability of different actors in the supply chain to ensure security of the medicines supply chain”.
Further, the report advocates for the use of competition law and policy to curb the abuse of dominant position in the market by the pharmaceutical companies. These abuse include charging excessive prices, restricting other companies from accessing the market, collusive tender practices, and restrictive agreements. It remarks, “Competition law represents an accountability mechanism for legal redress under the right-to-health framework and provides a powerful tool to check wrongful practices by pharmaceutical companies that engage in anti-competitive practices, which can also negatively affect access to medicines.”
Further, the report suggests the use of competition law to monitor the mergers between generic and brand name pharmaceutical companies, which could potentially block future market competition. It also states that a well-formulated competition law can curb anti-competitive practices at every stage of the pharmaceutical supply chain including restrictions for the supply of active pharmaceutical ingredients.
The report recommends that States:
- Adopt price control measures in pricing and reimbursement policies with a view to ensuring access of the population, and vulnerable groups particularly, to affordable medicines;
- Select countries with a similar level of economic development to that of the State concerned as reference countries in order to secure the lowest price medicines through external reference pricing;
- Monitor and regulate, if necessary, manufacturers’ selling prices as well as distribution mark-ups in the supply chain, while ensuring incentives for wholesalers and retailers for sustainable distribution;
- Resist trade policies that undermine the ability of States to reimburse the price of essential medicines to local pharmaceutical companies;
- Eliminate import tariffs on medicines, except when considered to be strategic to the promotion of local production of essential medicines;
- Remove taxes on all medicines, especially essential medicines, and consider other revenue options for health, such as excise taxes on socially harmful goods such as tobacco, alcohol and junk foods;
- Adopt competition laws and policies to prevent pharmaceutical companies from indulging in anti-competitive practices and promote competitive pricing of medicines together with strong enforcement;
- Promote competitive policies across therapeutic markets to secure reductions in prices of medicines over tiered pricing to secure a greater government role in decision-making related to prices of medicines.
MEDICINES LISTS
The report advocates for the preparation of a National List of Essential Medicines (NEML) to address the health needs of the people as a first step to ensure availability of essential medicines. It states that under the right-to- health framework, “the process of selection of essential medicines should be evidence-based, transparent and participatory”.
However, it notes that often, States exclude civil society and community representatives from the selection process of NEML. It further notes deficiencies in the approaches of the WHO Essential Medicines List (EML) process. First, it notes the reluctance to include patented medicines and cites the specific example of the exclusion of patented antiretrovirals (ARVs) like Raltegravir, Darunavir and Etravirine from EML.
It also points out that only 22 per cent of the 359 essential medicines on the 2003 WHO EML relate to non-communicable diseases (NCDs) and notes further that “several applications for the treatment of mental health, cancers and cardiovascular diseases are pending review by the WHO Expert Committee”. It underscores “the under-representation of medicines for NCDs in the WHO EML”.
The report further notes that it is important to “ensure that the revisions to the WHO EML are conducted in an inclusive and transparent manner that addresses concerns of all groups”.
It recommends that States: Adopt a national essential medicines list and regularly update it by selecting essential medicines that are evidence-based and adequately reflect the national burden of disease, irrespective of cost or patent status, including through a transparent and participatory determination process; ensure that access to essential medicines for treating mental health, drug dependence, sexual and reproductive health and palliative care is based purely on health needs and evidence and not restricted on account of extraneous non-health considerations; ensure that the list of National Essential Medicines is arrived at with participation of all stakeholders, including the affected communities, particularly the vulnerable groups.
PROCUREMENT
The report clearly underlines the importance of an efficient and transparent procurement of medicines to ensure the availability of medicines in public health facilities. It stresses that an “efficient procurement system is one that relies on transparent management, a limited drug selection that is based on a restricted list (for example, NEML), accurate and scientific forecasting of need, competitive tendering, bulk purchasing, pre-qualification of proposed suppliers and close monitoring of selected suppliers, and reliable financing.”
It further stresses the need for taking measures to address medicine stock-outs, observing that shortage of medicine stock forces patients to resort to more expensive private health centres, inappropriate medicines or even forego treatment altogether.
The report recommends the following measure to streamline the procurement mechanism: “Adopt scientific and evidence-based quantification of essential medicines, ensure competitive bidding, require stringent pre-qualification for suppliers, monitor delivery of medicines and formulate effective policies to address stock-outs”.
DISTRIBUTION
The report states that “the right to health obliges States to ensure that distribution systems function in a manner that secures physical accessibility to quality essential medicines at all points of distribution”. Therefore, it advocates for the control of the quality of the distribution chain to ensure that medicines should be transported and stored at the required temperature and as per the labeling requirements. The medicines should be stored in clean, dry and well-sanitised areas.
It therefore calls for urgent investment to develop adequate distribution infrastructure for public health facilities. As an alternative, the report proposes a provision in the procurement contract requiring the supplier to deliver medicines directly to district-level stores or health facilities. It recommends: “Increase financial, technical and logistical support to strengthen distribution networks, maintain the quality of medicines in transport and storage and adopt distributor certification programmes.”
RATIONAL AND APPROPRIATE USE
The report mentions that the State’s obligation under the right to health also extends to how medicines are prescribed, dispensed, sold and used. It notes that errors in prescription, dispensation and use of medicines can cause adverse health events and drug reactions. It states, “Incorrect choice of medicines by physicians has been linked to higher levels of resistance, increased costs, morbidity and mortality in patients”. It therefore advocates for the extensive use of Standard Treatment Guidelines (STG) as a way forward to address the issue.
The report also points out that many stakeholders perceive the unethical promotion of medicines as a serious concern. It observes: “Doctors are offered gifts under the pretext of continued medical education. Multinational pharmaceutical companies have been fined for promoting unapproved medicines, with little impact on their practices. Unethical promotion negatively affects the prescribing patterns of doctors, who would then tend to prescribe less rationally and to quickly adopt new medicines. Prescribers consequently obtain information on medicines from pharmaceutical companies, rather than consulting STGs”.
It recommends the “formulation of strong enforceable regulatory systems, with accountability measures, to discourage unethical marketing and promotion of medicines by pharmaceutical companies”.
It further makes the following recommendations: Develop and regularly update Standard Treatment Guidelines and ensure adequate training of prescribers as a part of continuing medical education policies; regulate pharmacies, including online pharmacies, and retailers to ensure appropriate dispensation of medicines; prohibit unethical commercial marketing and promotion of medicines by pharmaceutical companies through legal accountability measures based on strict penalties and cancellation of manufacturing licenses.
QUALITY
According to the Special Rapporteur’s report, the right-to-health framework obligates States to protect people from unsafe and poor-quality medicines. This obligation includes the registration and marketing of good quality, safe and efficacious products under ethically and medically validated clinical trials, continuous regulation of the quality of production of medicines and prevention of sub-standard and spurious medicines from being sold on the market after registration.
It clearly articulates the issue of access to data especially related to the quality, safety and efficacy of medicines that is necessary for the enjoyment of the right to health. Further, the report notes that in “the Special Rapporteur’s consultations, diverse stakeholders noted non-transparency of clinical trial data as a concern”.
Therefore, the Special Rapporteur “encourages States to take regulatory measures to ensure that information on the safety, quality and efficacy of medicines, even if negative, is made publicly available in functional trial registries”.
The report also finds that “contrary to popular belief, recent studies indicate that there may be fewer poor quality medicines on the market than previously estimated. A potential explanation for this could be the tendency to conflate poor-quality with counterfeit medicines”.
The report rejects the conflation of intellectual property issues with quality, safety and efficacy of medicines. It clearly states: “The Special Rapporteur also notes the ongoing global debate to deal with the growing challenge of counterfeit medicines. He points out that since the term ‘spurious/sub-standard/falsely-labelled/falsified and counterfeit’ (SSFFC) medicines was coined, it has regrettably been used as a catch-all phrase to represent anything from poor quality to ‘counterfeit’ medicines, which is specific to the domain of trademark violations. Such a linkage is counterproductive to access to medicines. This type of conflation was demonstrated by incidents in which unilateral action was taken by some countries against legitimate generic medicines as being counterfeit and even under the national laws in some countries, which included generic medicines under the definition of counterfeit medicines, thereby threatening (generics) import into that country. The Special Rapporteur expresses concern that an international legal remedy focusing on enforcement of trademark rights to counter the problem of counterfeit medicines takes away from the public health focus of strengthening of regulatory capacities in developing countries to deal with poor quality medicines and instead diverts limited State policing machinery to enforce private rights”.
The report recommends that States: Ensure transparency of data related to quality, safety and efficacy of medicines, including the mandatory publication of adverse data; increase budgetary support for national regulators and increase recruitment of inspectors at competitive salaries; improve South-South cooperation to conduct joint inspections of manufacturing facilities and share information and good practices; and avoid conflation of poor-quality medicines, a quality control issue, with counterfeit medicines, a trade issue.
