نصائح البحث
sorted by
30 shown of 439 entities
Access to medicines in the context of the right-to-health framework 2013, para. 3
- Paragraph text
- Access to medicines is an integral component of the right to health, as enunciated under article 12 of the International Covenant on Economic, Social and Cultural Rights (ICESCR). The Committee on Economic, Social and Cultural Rights in its interpretation of the normative content of article 12 issued its general comment No. 14 (2000) on the right to the highest attainable standard of health, which provides that all health services, goods and facilities, including medicines, should be made available, accessible, acceptable and of good quality. While several aspects of the right to health are understood to be progressively realizable, certain core obligations cast immediate obligations on States, including the provision of essential medicines to all persons in a non-discriminatory manner.
- Body
- Special Rapporteur on the right of everyone to the enjoyment of the highest attainable standard of physical and mental health
- Document type
- Special Procedures' report
- Topic(s)
- Equality & Inclusion
- Health
- Person(s) affected
- All
- Year
- 2013
Paragraph
Access to medicines in the context of the right-to-health framework 2013, para. 4
- Paragraph text
- The right-to-health framework sets out key elements that should be fulfilled by States to ensure access to medicines. First, medicines should be made available in sufficient quantities within a country to meet the needs of the people. In fulfilling this obligation States should select essential medicines that reflect the priority diseases in the population, procure them in sufficient quantities and ensure their availability in all public health facilities. Second, medicines should be accessible in terms of economic affordability and physical distance from where the population lives on the basis principle of non-discrimination. Third, medicines should be determined to be culturally and ethically acceptable to the population. Finally, States also have the obligation to put in place strong regulatory mechanisms and transparent processes which ensure the quality, safety and efficacy of medicines.
- Body
- Special Rapporteur on the right of everyone to the enjoyment of the highest attainable standard of physical and mental health
- Document type
- Special Procedures' report
- Topic(s)
- Equality & Inclusion
- Health
- Person(s) affected
- All
- Year
- 2013
Paragraph
Access to medicines in the context of the right-to-health framework 2013, para. 5
- Paragraph text
- Furthermore, States have the obligation to respect, protect and fulfil the right to health, including access to medicines. The duty to respect extends to the obligation of States to refrain, inter alia, from denying or limiting equal access for all persons, including vulnerable groups, to all health services, including medicines. The duty to protect requires a State to ensure that third parties do not obstruct the enjoyment of the right to health. For example, a State should ensure that privatization of the health sector and the supply of medicines by private companies does not constitute a threat to the availability, accessibility, acceptability of quality medicines. The duty to protect also extends to the regulation of the marketing and sale of safe and good quality medicines by third parties. Finally, the duty to fulfil necessitates that States take positive measures that enable and assist individuals and communities to enjoy the right to health and give sufficient recognition to the right to health in the national political and legal systems, preferably by way of legislative implementation. In this context and as part of States' immediate obligations to take deliberate, concrete and targeted steps towards the full realization of the right to health, States should adopt a national health policy with a detailed national plan of action aimed at ensuring access to medicines.
- Body
- Special Rapporteur on the right of everyone to the enjoyment of the highest attainable standard of physical and mental health
- Document type
- Special Procedures' report
- Topic(s)
- Equality & Inclusion
- Health
- Person(s) affected
- All
- Year
- 2013
Paragraph
Access to medicines in the context of the right-to-health framework 2013, para. 6
- Paragraph text
- While States have the primary responsibility for enhancing access to medicines, it is a shared responsibility in which numerous national and international actors have a role to play. In its general comment No. 3 (1990) on the nature of States parties' obligations, the Committee on Economic, Social and Cultural Rights also stressed the obligation of States to take steps, individually and through international assistance and cooperation, especially economic and technical, towards the full realization of the rights recognized in the Covenant, including the right to health. Moreover, in the spirit of Articles 55 and 56 of the Charter of the United Nations, articles 2(1) and 23 of the Covenant, as well as the Alma-Ata Declaration on Primary Health Care, States should recognize the essential role of international cooperation and comply with their commitment to take joint and separate action to achieve the full realization of the right to health. According to the Human Rights Guidelines for Pharmaceutical Companies in relation to Access to Medicines, pharmaceutical companies should integrate human rights, including the right to health, into their strategies, policies, programmes, projects and activities.
- Body
- Special Rapporteur on the right of everyone to the enjoyment of the highest attainable standard of physical and mental health
- Document type
- Special Procedures' report
- Topic(s)
- Equality & Inclusion
- Governance & Rule of Law
- Health
- Person(s) affected
- All
- N.A.
- Year
- 2013
Paragraph
Access to medicines in the context of the right-to-health framework 2013, para. 7
- Paragraph text
- Market-oriented approaches to medicines in a highly competitive global marketplace often project issues related to access to medicines as a matter of profit rather than a public health concern. While it is understandable that private pharmaceutical companies should follow such an approach, there is a growing need for States to balance that market-driven perspective by positioning access to medicines in the right-to-health framework. There is thus the need to shift the dominant market-oriented paradigm on access to medicines towards a right-to-health paradigm and reaffirm 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 of the enjoyment of the right to health.
- Body
- Special Rapporteur on the right of everyone to the enjoyment of the highest attainable standard of physical and mental health
- Document type
- Special Procedures' report
- Topic(s)
- Equality & Inclusion
- Health
- Person(s) affected
- All
- Year
- 2013
Paragraph
Access to medicines in the context of the right-to-health framework 2013, para. 8
- Paragraph text
- Ensuring access to medicines also requires a functioning health system that encapsulates the key elements of the right to health: availability, accessibility, acceptability and quality. As part of the State obligation to fulfil the right to health and with a view to the progressive realization of access to affordable and quality medicines, the Special Rapporteur urges States to adopt a detailed national plan of action on medicines. The plan of action should be backed by a strong political will and commitment that prioritizes access to medicines within the public health budget and allocates resources accordingly. This is particularly pertinent in the context of the current global economic crisis, where some States are increasingly taking retrogressive measures such as reducing spending on health by reducing national health budgets. The Special Rapporteur stresses that States have the burden of proving that deliberately retrogressive measures have been introduced after careful consideration of all alternatives and that they are justified under full use of the State party's maximum available resources.
- Body
- Special Rapporteur on the right of everyone to the enjoyment of the highest attainable standard of physical and mental health
- Document type
- Special Procedures' report
- Topic(s)
- Equality & Inclusion
- Health
- Person(s) affected
- All
- N.A.
- Year
- 2013
Paragraph
Access to medicines in the context of the right-to-health framework 2013, para. 11
- Paragraph text
- An efficient and functional health system is crucial to ensure the availability of medicines, particularly essential medicines, in sufficient quantities, at all times and in all public health facilities. Under the right-to-health framework, States have an immediate obligation to take legal and administrative measures to ensure that access to essential medicines for their populations is secured by all available means. However, a third of the world's population, living mainly in developing countries, still do not have regular access to essential medicines. During the period 2001-2009, the average availability of essential medicines in public health facilities was only 42 per cent and in private sector facilities was 64 per cent. For chronic conditions, most of which require life-long access to medicines, the availability in public and private sectors was even poorer, at 36 per cent and 55 per cent respectively. Despite momentous gains in the past decade, only 8 million out of 14.8 million people living with HIV globally receive necessary treatment.
- Body
- Special Rapporteur on the right of everyone to the enjoyment of the highest attainable standard of physical and mental health
- Document type
- Special Procedures' report
- Topic(s)
- Equality & Inclusion
- Health
- Person(s) affected
- All
- Year
- 2013
Paragraph
Access to medicines in the context of the right-to-health framework 2013, para. 17
- Paragraph text
- Lack of data on the price difference between locally produced and imported medicines is also a drawback in promoting local production. To help determine the affordability of locally produced medicines in the long term, States should also collect disaggregated data on the prices of imported medicines in comparison to locally produced medicines.
- Body
- Special Rapporteur on the right of everyone to the enjoyment of the highest attainable standard of physical and mental health
- Document type
- Special Procedures' report
- Topic(s)
- Economic Rights
- Equality & Inclusion
- Health
- Person(s) affected
- All
- Year
- 2013
Paragraph
Access to medicines in the context of the right-to-health framework 2013, para. 20
- Paragraph text
- According to the right-to-health framework, medicines should be economically accessible to all sectors of the population. Medicines should therefore be priced in a fair and equitable manner and be affordable so as to not disproportionately burden poorer households. This is an even greater problem in developing countries, where up to two-thirds of expenditure on medicines is individually financed through out-of-pocket payments. Such payments are primarily responsible for catastrophic health expenditures, annually pushing approximately 100 million people, mostly in developing countries, into poverty. Ensuring affordable and equitable pricing of essential medicines is therefore a key determinant of access to medicines in most developing countries.
- Body
- Special Rapporteur on the right of everyone to the enjoyment of the highest attainable standard of physical and mental health
- Document type
- Special Procedures' report
- Topic(s)
- Equality & Inclusion
- Health
- Person(s) affected
- All
- Year
- 2013
Paragraph
Access to medicines in the context of the right-to-health framework 2013, para. 22
- Paragraph text
- States which responded to the Special Rapporteur's survey reported on the use of price control mechanisms to promote affordability of medicines, particularly essential medicines. Accordingly, external reference pricing (ERP), therapeutic reference pricing (TRP), as well as the regulation of manufacturers' selling price and distributor's mark-ups, have been applied as the most common methods for setting a ceiling price for medicines. States also reported the use of competition law as the preferred indirect price control mechanism. Tax incentives to manufacturers, wholesalers and retailers and government subsidies to manufactures were indicated as other methods of indirect control used by States to control prices of medicines.
- Body
- Special Rapporteur on the right of everyone to the enjoyment of the highest attainable standard of physical and mental health
- Document type
- Special Procedures' report
- Topic(s)
- Economic Rights
- Health
- Person(s) affected
- All
- N.A.
- Year
- 2013
Paragraph
Access to medicines in the context of the right-to-health framework 2013, para. 23
- Paragraph text
- According to the respondent States, ERP is the primary method used by regulatory bodies to set a retail price above which medicines cannot be sold to consumers. Under ERP, the price of a specific medicine in one or several countries is used as a benchmark to set or negotiate the price of medicines in a given country. Regrettably, some developing countries select developed countries, with higher medicines prices, as reference countries, resulting in substantially higher medicines prices. For example, in 23 developing countries, public sector prices for generic medicines were 1.9 to 3.7 times higher than even the international reference price (calculated at the median price of multi-sourced medicines offered to developing countries by different suppliers) and for originator brands, 5.3 to 20.5 times the international reference price. To secure the lowest price for medicines and enhance affordable and equitable access to essential medicines, purchasing States should therefore select reference countries whose level of economic development is similar to theirs. If States use high-price countries for referencing, they should adjust the benchmark price to the levels of local income per capita when setting prices.
- Body
- Special Rapporteur on the right of everyone to the enjoyment of the highest attainable standard of physical and mental health
- Document type
- Special Procedures' report
- Topic(s)
- Equality & Inclusion
- Health
- Person(s) affected
- All
- Year
- 2013
Paragraph
Access to medicines in the context of the right-to-health framework 2013, para. 25
- Paragraph text
- Under the right to health, access to information includes providing consumers with information on the prices of medicines. This has been a good practice adopted in some States, which require by law that the maximum retail price of medicines be printed on medicine packages.
- Body
- Special Rapporteur on the right of everyone to the enjoyment of the highest attainable standard of physical and mental health
- Document type
- Special Procedures' report
- Topic(s)
- Equality & Inclusion
- Health
- Person(s) affected
- All
- Year
- 2013
Paragraph
Access to medicines in the context of the right-to-health framework 2013, para. 29
- Paragraph text
- In some States, the use of health insurance schemes to reimburse patients the cost of essential medicines is common and vital to ensuring access to affordable medicines for people. This is done through the subsidizing of prescription medicines, usually from a preferred list of medicines, with patients making a co-payment for the medicines and the State bearing the remaining cost. The Special Rapporteur notes that the trade policies of some countries are pushing trade partners to establish judicial or administrative forums to determine when a reimbursement price unlawfully restricts the "value" of a patent on a medicine, thereby restraining the listing of such a medicine on the reimbursement schemes. At best, compelling governments to establish such forums is a waste of crucial administrative resources that could be spent delivering health goods and services. The Special Rapporteur therefore advises States to guard against trade interests prevailing over primary and immediate obligations to ensure access to affordable medicines.
- Body
- Special Rapporteur on the right of everyone to the enjoyment of the highest attainable standard of physical and mental health
- Document type
- Special Procedures' report
- Topic(s)
- Equality & Inclusion
- Health
- Person(s) affected
- All
- N.A.
- Year
- 2013
Paragraph
Access to medicines in the context of the right-to-health framework 2013, para. 31
- Paragraph text
- States which responded to the Special Rapporteur's survey also recommended, as a good practice in reducing medicine prices, the regulation of the price at which manufacturers can sell medicines to intermediaries along with the regulation of distribution mark-ups in the supply chain. In this context, the Special Rapporteur 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.
- Body
- Special Rapporteur on the right of everyone to the enjoyment of the highest attainable standard of physical and mental health
- Document type
- Special Procedures' report
- Topic(s)
- Governance & Rule of Law
- Health
- Person(s) affected
- All
- N.A.
- Year
- 2013
Paragraph
Access to medicines in the context of the right-to-health framework 2013, para. 34
- Paragraph text
- Taxes constitute the third largest component in price add-ons for medicines after the manufacturer's price and distribution mark-ups paid by the consumer. At the country level, the tax range for medicines is between 5 and 34 per cent. These can include State tax, stamp duties, community tax, State excise duties and freight tax. Taxes are applied variably depending on whether a medicine is locally produced or imported and sold in the in the public or private sector. Almost half of the States surveyed reported that taxes are not levied on medicines. Of those in which they are, some provide exemptions for medicines listed on the national essential medicines lists, donated medicines, antiretroviral drugs, imported generic medicines, cancer and diabetes medicines. The Special Rapporteur encourages States to refrain from taxing medicines, especially essential medicines, and instead consider other ways to generate revenue for health, such as so-called sin taxes - excise taxes levied on socially harmful goods such as tobacco, alcohol and junk foods.
- Body
- Special Rapporteur on the right of everyone to the enjoyment of the highest attainable standard of physical and mental health
- Document type
- Special Procedures' report
- Topic(s)
- Equality & Inclusion
- Health
- Person(s) affected
- All
- N.A.
- Year
- 2013
Paragraph
Access to medicines in the context of the right-to-health framework 2013, para. 40
- Paragraph text
- In order to ensure availability of essential medicines, States should first identify medicines required to address priority health needs of the population under a national essential medicines list (NEML). This is consistent with States' core obligation to provide essential medicines listed in the WHO Essential Medicines List (EML). These include painkillers, anti-infectives, anti-bacterials, anti-tuberculosis, anti-retrovirals, blood products, cardiovascular medicines, vaccines and vitamins.
- Body
- Special Rapporteur on the right of everyone to the enjoyment of the highest attainable standard of physical and mental health
- Document type
- Special Procedures' report
- Topic(s)
- Health
- Person(s) affected
- All
- Year
- 2013
Paragraph
Access to medicines in the context of the right-to-health framework 2013, para. 46
- Paragraph text
- States have devised ingenious ways in resource-limited settings to ensure access to the most essential medicines, as was highlighted during the Special Rapporteur's consultations. For example, in one country essential medicines are classified into different segments as per product: vital medicines (e.g. emergency medicines), essential medicines (e.g. to treat fever, headaches) and necessary medicines (e.g. multivitamins). According to the procurement rules in that country, health facilities should procure the required quantity of vital medicines first, then essential, and finally necessary medicines. This helps minimize stock-outs affecting the most vital health concerns while more sustainable solutions are devised to meet the needs for other medicine. The Special Rapporteur encourages such innovative approaches, which are tailored to local conditions and are consistent with the core right to health obligation of ensuring the availability and accessibility of essential medicines.
- Body
- Special Rapporteur on the right of everyone to the enjoyment of the highest attainable standard of physical and mental health
- Document type
- Special Procedures' report
- Topic(s)
- Equality & Inclusion
- Health
- Person(s) affected
- All
- Year
- 2013
Paragraph
Access to medicines in the context of the right-to-health framework 2013, para. 47
- Paragraph text
- Efficient and transparent procurement of medicines is central to ensuring the availability of medicines in sufficient quantities in all public health facilities. Procurement of medicines occurs at the international, national, regional and local levels. Inefficiencies of procurement at each level can cause unreliable medicine supplies and higher costs. 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. The Special Rapporteur is pleased to note that most States that responded to his questionnaire have formulated national medicine procurement policies.
- Body
- Special Rapporteur on the right of everyone to the enjoyment of the highest attainable standard of physical and mental health
- Document type
- Special Procedures' report
- Topic(s)
- Governance & Rule of Law
- Health
- Person(s) affected
- All
- Year
- 2013
Paragraph
Access to medicines in the context of the right-to-health framework 2013, para. 48
- Paragraph text
- With respect to quantification of medicines needs, one developing country experience indicates reliance on historical data gathered from hospitals all over the country and the epidemiological pattern of disease, which are reviewed every six months. A 20 per cent buffer to account for shortages or seasonal increases in disease is then added. Stock shortages are nevertheless commonly reported in this State. Fewer than half of the respondent States had a policy in place to address medicines shortages. States attributed stock shortages to insufficient funding for procurement, inaccurate forecasting of needs, inadequate buffer stock of essential medicines, and inefficient distribution and record-keeping systems. Stock shortages can force patients to resort to more expensive private health centres, inappropriate medicines or even forego treatment altogether. Over-quantification of demand, on the other hand, is equally harmful, as it can lead to the wastage of scarce resources and the expiry of medicines, for which safe disposal systems are lacking in many States. States are therefore encouraged to develop more scientific, reliable and evidence-based methods for forecasting and quantification such as the use of computerized methods for quantification and reliance on data about actual consumption where there are reliable records available. Participation of civil society and the affected communities must be encouraged as it helps create information networks to monitor and inform competent health authorities on medicine stocks.
- Body
- Special Rapporteur on the right of everyone to the enjoyment of the highest attainable standard of physical and mental health
- Document type
- Special Procedures' report
- Topic(s)
- Health
- Humanitarian
- Person(s) affected
- All
- Year
- 2013
Paragraph
Access to medicines in the context of the right-to-health framework 2013, para. 49
- Paragraph text
- International shortage of medicines, especially cancer medicines, was also raised as an issue by civil society participants to the survey. Such shortages in medicines are attributed to a limited number of manufacturers, shortages of raw materials, production problems and stockpiling. They negatively impact States' ability to procure medicines for public health facilities and seriously affect their availability to patients. States should therefore identify particular medicines markets that face such shortages and promote the development of local production of these medicines to ensure supply sustainability in the long term.
- Body
- Special Rapporteur on the right of everyone to the enjoyment of the highest attainable standard of physical and mental health
- Document type
- Special Procedures' report
- Topic(s)
- Equality & Inclusion
- Health
- Person(s) affected
- All
- Year
- 2013
Paragraph
Access to medicines in the context of the right-to-health framework 2013, para. 54
- Paragraph text
- 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. The distribution chain places various responsibilities on different entities, and may include private actors, who also have a responsibility to ensure that their actions do not adversely impact on the right to health. Most States consulted by the Special Rapporteur have national regulations in place for distribution of essential medicines in the public and private sector. These regulations cover storage, transport and handling of medicines and temperature sensitive products.
- Body
- Special Rapporteur on the right of everyone to the enjoyment of the highest attainable standard of physical and mental health
- Document type
- Special Procedures' report
- Topic(s)
- Equality & Inclusion
- Health
- Person(s) affected
- All
- N.A.
- Year
- 2013
Paragraph
Access to medicines in the context of the right-to-health framework 2013, para. 55
- Paragraph text
- To control the quality of medicines through the distribution chain, medicines must be maintained at the required temperature and according to labelling requirements, and stored in clean, dry and well-sanitized areas. States reported several challenges in meeting these requirements. Poor warehouses and cold storage facilities were cited as the major obstacles to maintaining the quality of essential medicines in developing countries, especially in rural areas. In some countries temporary storage was resorted to which lacked temperature or quality control standards. Such practices can be detrimental to the quality of medicines and this calls for urgent investment to develop adequate distribution infrastructure for public health facilities. Alternatively, States may consider including in the procurement contract a condition requiring medicines to be delivered directly to district level stores or health facilities.
- Body
- Special Rapporteur on the right of everyone to the enjoyment of the highest attainable standard of physical and mental health
- Document type
- Special Procedures' report
- Topic(s)
- Equality & Inclusion
- Health
- Person(s) affected
- All
- Year
- 2013
Paragraph
Access to medicines in the context of the right-to-health framework 2013, para. 56
- Paragraph text
- The involvement of numerous agencies throughout the distribution process would necessitate continuous monitoring of timely distribution and medicine quality. Diversions of donated low-priced medicines from public health facilities into the private sector were observed in some countries. This can be addressed through effective monitoring of the distribution chain. States surveyed by the Special Rapporteur, however, reported weak data collection and monitoring systems, partly due to lack of skilled personnel to manage these systems. There is therefore an urgent need to build government capacity for identification of weaknesses in distribution systems and to devise cost-effective methods to monitor the performance and suitability of distributors. To address this situation, States may consider adopting certification programmes for distributors, a successful practice in some developing countries. Additionally, States could invest in cost-effective Internet- and mobile phone- based technologies linked to centralized computer data systems, relaying real-time data to monitor the movement of medicines from procurement through distribution and transportation and finally to delivery at health centres. Participation of communities and civil society is vital for making such measures effective.
- Body
- Special Rapporteur on the right of everyone to the enjoyment of the highest attainable standard of physical and mental health
- Document type
- Special Procedures' report
- Topic(s)
- Health
- Person(s) affected
- All
- Year
- 2013
Paragraph
Access to medicines in the context of the right-to-health framework 2013, para. 57
- Paragraph text
- The State obligation of ensuring access to acceptable medicines under the right to health relates to how medicines are prescribed, dispensed, sold and used. Errors in choosing or writing prescriptions, dispensation errors by pharmacists and incorrect consumption of medicines by patients can cause adverse health events and drug reactions. States' obligation to protect health also extends to safeguarding the public against the proliferation of irrational use of medicines, which results in wastage of scarce supplies and widespread health hazards.
- Body
- Special Rapporteur on the right of everyone to the enjoyment of the highest attainable standard of physical and mental health
- Document type
- Special Procedures' report
- Topic(s)
- Equality & Inclusion
- Health
- Person(s) affected
- All
- Year
- 2013
Paragraph
Access to medicines in the context of the right-to-health framework 2013, para. 59
- Paragraph text
- In many developing countries, pharmacies are the first point of contact for patients with the health-care system. Despite regulations restricting the sale of prescription medicines over-the-counter (OTC), in many developing countries this practice is rampant. In the case of antibiotics, unrestricted sale combined with irrational prescription have led to the public health threat of increased resistance to antibiotics. Countries with more restrictive antibiotic prescription have recorded relatively lower rates of resistance. Rational use of appropriate medicines requires strong enforcement of regulations by States. It also requires pharmacies and health centres to restrict OTC sale of medicines in accordance with law.
- Body
- Special Rapporteur on the right of everyone to the enjoyment of the highest attainable standard of physical and mental health
- Document type
- Special Procedures' report
- Topic(s)
- Health
- Person(s) affected
- All
- N.A.
- Year
- 2013
Paragraph
Access to medicines in the context of the right-to-health framework 2013, para. 60
- Paragraph text
- Numerous stakeholders perceive unethical commercial marketing and promotion of medicines by pharmaceutical companies as a serious concern. Billions of dollars are spent by the pharmaceutical industry on marketing through sales representatives, samples and advertising. 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. During the consultations, some States pointed to the existence of voluntary national industry codes to address pharmaceutical promotion. However, these have been criticized as ineffective. The Special Rapporteur recommends formulating strong enforceable regulatory systems, with accountability measures, to discourage unethical marketing and promotion of medicines by pharmaceutical companies.
- Body
- Special Rapporteur on the right of everyone to the enjoyment of the highest attainable standard of physical and mental health
- Document type
- Special Procedures' report
- Topic(s)
- Equality & Inclusion
- Health
- Person(s) affected
- All
- Year
- 2013
Paragraph
Access to medicines in the context of the right-to-health framework 2013, para. 61
- Paragraph text
- According to the right-to-health framework, States are required to protect the population from unsafe and poor-quality medicines. Quality assurance for medicines includes such aspects as 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.
- Body
- Special Rapporteur on the right of everyone to the enjoyment of the highest attainable standard of physical and mental health
- Document type
- Special Procedures' report
- Topic(s)
- Equality & Inclusion
- Health
- Person(s) affected
- All
- Year
- 2013
Paragraph
Access to medicines in the context of the right-to-health framework 2013, para. 62
- Paragraph text
- Poor quality medicines are genuine products that do not meet quality specifications due to poor manufacturing practices. They can cause drug resistance, adverse effects and even death. 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.
- Body
- Special Rapporteur on the right of everyone to the enjoyment of the highest attainable standard of physical and mental health
- Document type
- Special Procedures' report
- Topic(s)
- Health
- Person(s) affected
- All
- Year
- 2013
Paragraph
Access to medicines in the context of the right-to-health framework 2013, para. 63
- Paragraph text
- Accessibility of information with respect to the quality, safety and efficacy of medicines is necessary for the enjoyment of the right to health. Before acquiring marketing approval, pharmaceutical companies are legally required in most countries to provide data demonstrating the safety, quality and efficacy of new medicines, generated from medically and ethically valid clinical trials. However, during the Special Rapporteur's consultations, diverse stakeholders noted non-transparency of clinical trial data as a concern. Trial data is not made public by pharmaceutical companies and regulators on the ground of protecting commercial information. Moreover, data relied upon for registration of medicines is often subject to publication bias (only positive results are published or are overrated), which is misleading and potentially harmful for patients. The Special Rapporteur notes with satisfaction that national and regional regulatory bodies are taking steps to make this data available through clinical trial registries. However, critics still point to content and functionality shortcomings in these registries. 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.
- Body
- Special Rapporteur on the right of everyone to the enjoyment of the highest attainable standard of physical and mental health
- Document type
- Special Procedures' report
- Topic(s)
- Equality & Inclusion
- Health
- Person(s) affected
- All
- N.A.
- Year
- 2013
Paragraph
Access to medicines in the context of the right-to-health framework 2013, para. 64
- Paragraph text
- Poor-quality medicines are not related solely to imported medicines, as it is popularly perceived. Therefore quality inspections cannot be limited to border controls and inspections. It is important to have standard regulatory requirements for both domestically produced and imported medicines, along with regular inspections of production facilities and distribution chains for which persistent shortages have been reported.
- Body
- Special Rapporteur on the right of everyone to the enjoyment of the highest attainable standard of physical and mental health
- Document type
- Special Procedures' report
- Topic(s)
- Equality & Inclusion
- Health
- Person(s) affected
- All
- Year
- 2013
Paragraph