Access to medicines

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Access to medicines refers to the reasonable ability for people to get needed medicines required to achieve health. [1] Such access is deemed to be part of the right to health as supported by international law since 1946. [2]

Contents

The World Health Organization states that essential medicines should be available, of good quality, and accessible. [2] Reasonable access to medicines can be in conflict with intellectual property and free markets. [3] In the developing world people may not get treatment for conditions like HIV/AIDS. [4]

Hindrances to access

Most hindrances to access revolve around market competition and lack of it.

Patent protection and exclusivity

Patents provide an owner exclusive rights to a product or process for 20 years in a particular territory. The owner of the patent has the right to prevent the manufacture, use, sell, import, or distribution of the patented product. [5] It is argued that patent protection allows pharmaceutical companies a monopoly on particular drugs and processes. [6] [7]

Data exclusivity

Data exclusivity is a regulatory measure limiting the use of clinical trial data and provides conductor of the trial temporary exclusive rights to the data. [6] Many suggest that extending exclusivity periods can have consequences in delivering medication, especially generic brands, to developing countries. However, extending patent terms can be reinvested for research and development and/or a source of funding for drug donations to low-income countries. [8] Others suggest that data exclusivity works to diminish the availability of generic drugs. Many argue that pharmaceutical companies push for data exclusivity—seeking to extend their monopolies by advocating for market exclusivity provided by patents and data exclusivity, or protection for new medicine. [6]

Cost

Martin Shkreli testifying before the House Committee on Oversight and Government Reform, 2016 Martin Shkreli House Committee on Oversight and Government Reform 2016.jpg
Martin Shkreli testifying before the House Committee on Oversight and Government Reform, 2016

In some countries pharmaceutical company have ultimate control of the pricing of their patented product. Therefore, the owner has control of the pricing of the medication, based on the price level the owner deems best to reflects their ability to manufacture and the level of profit desired. Purchasers have little say over the price set. [9] It is argued that competition is necessary to lower drug prices and improve access to affordable medications. [10] [11]

Price gouging is defined as the excessive increase in prices by sellers of essential goods to a level deemed higher than reasonable or fair. This sharp increase in prices may leave the buyer vulnerable. It also leads to inequitable access to essential goods among different socioeconomic groups. [12] It is argued that pharmaceutical companies have dramatically increased prices for treatments that are essential in treating diseases such as HIV/AIDS, hepatitis C, and cancer. [13]

Lack of Generic Brands

Many argue that generic brand production in developing countries increases competition and therefore is essential to bridge the global drug gap. [11] [9] As argued by various sources, the push for more measures such as market and data exclusivity, hinders low-income countries' ability to manufacture and produce generic drugs. [6] However, low-income countries often lack the essential infrastructure to allow for generic brand production. [9] [8] In order the use of the medication to be effective, it must be manufactured in optimal laboratory conditions. Developing countries often lack air conditioning, stable electrical power, or refrigerators to store samples and chemicals. [8] Also, quality generic brand production is limited by a government's ability to create effective spaces of market competition and to monitor the quality of generics brands; this ability has been found to be limited in certain developing countries. [14] It also argued that international aid, state investment, and measures for infection prevention are necessary to allow for generic brand production in low-income countries. [9]

Language and cultural barriers

Among populations that do not speak the main language in an area access to medicine can be hindered by language barriers as well as other cultural barriers. There is evidence that access is improved by having medical workers that speak the language of patients, as patients will be more likely to know about and to take medicines. [15]

Legislation

Logo of the World Trade Organization (WTO) World Trade Organization (logo and wordmark).svg
Logo of the World Trade Organization (WTO)

Trips agreement

The Agreement on Trade-Related Aspects of Intellectual Property Rights (TRIPS), is a multilateral agreement between all member nations of the World Trade Organization (WTO), effective January 1995. [16] This agreement introduced global standards for enforcing and protecting nearly all forms of intellectual property rights (IPR), including those for patents and data protection. Under the TRIPS Agreement, WTO member nations, with a few exceptions, are required to adjust their laws to the minimum standards of IPR protection. Member nations are also obligated to follow specific enforcement guidelines, remedies, and dispute resolution procedures. Before TRIPS, other international conventions and laws did not specify minimum standards for intellectual property laws in the international trading system. The TRIPS Agreement is argued to have the greatest effect on the pharmaceutical industry and access to medicines. [17] It is argued that the TRIPS agreement negatively impacted generic drug industries in countries such as India. However, others argue that the agreement is open to interpretation. A clause in the TRIPS agreement allows compulsory licensing, which permits the manufacture of generic brands of patented drugs, at prices set in a competitive market in cases of national emergencies. [9] For example, many believe that the HIV/AIDs crisis in Africa and South East Asia and the inadequate access to essential AIDs medications constitute a national emergency. Therefore, the TRIPS Agreement can be interpreted to allow the manufacture of generic brands of patented HIV/AIDs drugs [9]

Doha Declaration

Further legislation such as Doha Declaration of 2001 worked to rectify the negative impact of the TRIPS Agreement. [18] The Doha Declaration on the TRIPS Agreement and Public Health, effective November 2001, was adopted by WTO Ministerial Conference of 2001. Many argued that the TRIPS Agreement hindered developing countries from implementing measures to improve access to affordable medicines, especially for diseases of public health concern, such as HIV, tuberculosis, and malaria. The Doha Declaration responds to concerns of developing countries that patent protection rules and other IPRs were hindering access to affordable medicines for populations in those countries. [19] The Doha Declaration emphasizes the flexibility of the TRIPS Agreement and highlights the right of respective government to interpret the TRIPS Agreement in terms of public health. It refers to specific parts of TRIPS, such as the use of compulsory licensing for pharmaceutical drugs only in the case of a national emergency and circumstances of extreme urgency and the right to determine what constitutes this—such as to address public health issues. [19]

Paragraph 6 System

The declaration also allows for countries without manufacturing capabilities to turn to another country for the export of generic brands of patented medicines. [20] [18] This is known as the paragraph 6 system. [21] As of 2010 it had only been called upon once, concerning the export of medicines from Canada to Rwanda, with varying opinions about its results and potential. [21] [22] [23]

Differences by geography

HIV/AIDS prevalence world map in 2009 according to UNAIDS data AIDS and HIV prevalence 2009.svg
HIV/AIDS prevalence world map in 2009 according to UNAIDS data

Africa

There is estimated to be more than 4 million HIV infected individuals in South Africa. Out of this, only 10,000 individuals are able to afford access to essential AIDS medications at their current prices. In Malawi, out of one million infected individuals, 30 have access to life-sustaining essential AIDS medications. [9] In Uganda, out of the estimated 820,000 infected individuals, only about 1.2% can afford essential AIDS medications. [24]

Latin America

There is estimated to be 1.8 million individuals HIV infected individuals in the Latin American region. Brazil is argued to be one of the most affected by the AIDS epidemic. There is also a high prevalence of HIV in smaller countries such as Guatemala, Honduras, and Belize. [25] However, Brazil is argued not to have restrictive patent laws. In the mid-1990s, Brazil began manufacturing generic versions of vital AIDS medication. Due to this, Brazil's AIDS mortality rate declined by almost 50%. [9]

India

Many Indian families live below the poverty line due to healthcare expenses. From 1972 to 2005, due to a lack of patent laws for drugs in India, Indian drug companies were able to use alternative, legal processes to manufacture generic versions of drugs. These generic drug companies were able to produce low-priced drugs that were considered among the lowest in the world. This allowed India to provide free antiretroviral treatment to 340,000 HIV infected individuals in the country. Majority of adult antiretroviral drugs purchased for donor-funded programs in developing countries were supplied by Indian generic drug companies. In compliance to the Agreement on Trade-Related Aspects of Intellectual Property Rights (TRIPS), India reintroduced patent laws for drugs in 2015. [10]

Differences by sector

Vaccines

The majority of deaths from vaccine-preventable diseases occur in low and middle income countries. In low-income countries, more than 90% of deaths are from pneumococcal disease, 95% from Hib, and 80% from hepatitis B. Although widely used by high-income countries, in 2006, Hib vaccine usage in Africa was about 24% In the Americas, Hepatitis B vaccine usage was at 90%. In Southeast Asia, where there is hepatitis B epidemic, the Hib vaccine coverage was only 28%. The human papillomavirus (HPV) vaccine is considered the most expensive vaccine in history. However, the majority of those that have cervical cancer are in developing countries. [11]

Epidemics and access

HIV/AIDs

The appearance of generic manufacturers in low-income countries, such as India and Brazil, was key to increasing access to HIV/AIDS treatment in low- and middle- income countries (LMICs). Due to the introduction of generic brand competition, first-line antiretroviral drugs' prices dropped by more than 99%, from $10,000/year per patient in 2000 to less than $70 in 2014. [11]

Daraprim

The chemical structure of pyrimethamine, commonly known as Daraprim 5-(4-chlorophenyl)-6-ethylpyrimidine-2,4-diamine 200.svg
The chemical structure of pyrimethamine, commonly known as Daraprim

On August 10, 2015, Turing Pharmaceuticals, a pharmaceutical company owned by Martin Shkreli, purchased the rights to a Daraprim. [26] Daraprim, an anti-parasitic and anti-malarial drug, is considered an essential drug for HIV treatments. It is widely used to treat patients with AIDS-related and AIDs-unrelated toxoplasmosis. [27] At the time, no other generic versions of the drug was available. Turing dramatically raised the price of the drug from $13.50 a tablet to $750, a 5000% increase. [28]

Campaigns

A number of countries and organizations have efforts to improve access to medicines in specific areas of the world.

The Canada's Access to Medicines Regime allows developing countries to bring in medicines at lower cost. [29] It specifically allows companies in Canada who may not own the right to make a medication to do so for export to certain countries in the developing world. [30]

Médecins Sans Frontières has had such a campaign since 1999 known as the Campaign for Access to Essential Medicines. [31]

In Tanzania, the Ministry of Health and the Tanzania Food and Drugs Authority and the Strategies for Enhancing Access to Medicines Program introduced accredited drug dispensing outlets, with aid from Bill & Melinda Gates Foundation. It worked to create a nationwide chain of dispensers, which provide quality pharmaceutical drugs and services to its citizens. [32]

The GAVI vaccination alliance is an international public-private partnership, created in 2000, devoted to improving access to vaccines in low-income countries. [33] The organization partners with several developing countries, donor governments, research agencies, and vaccines companies in both in industrialized and developing countries. It also partners with organizations such as the World Health Organization, UNICEF, the World Bank, the Bill & Melinda Gates Foundation and other private philanthropists. [34] GAVI is noted as an important source of external funding for vaccines in low-income countries and played a crucial role in introducing the HPV vaccine and other new vaccines to developing countries. [11]

In Kenya, the Kenya Coalition for Access to Essential Medicines (KCAEM), was formed in response to Kenya's Industrial Property Act 2001. The act outlined the rights of patent holders. Members of this coalition are local community-based and national NGOs, international NGOs, healthcare providers, journalists, lawyers and other individuals. The coalition works primarily with people living with HIV/AIDS and access to essential HIV/AIDS medications and treatments. [35] It urges for flexibility in interpreting the TRIPS Agreement and efforts to implement production of generic antiretroviral drugs by local manufacturers and/or to import inexpensive drugs. [36] It also calls for pharmaceutical companies to reduce the price of their medications. [37] The coalition has garnered support from key government officials and organizations such as Kenyan Property Institute, Kenyan Ministry of Trade, and the Minister of Trade Mr. Nicholas Biwott MP. [35]

See also

Related Research Articles

The Doha Declaration on the TRIPS Agreement and Public Health was adopted by the WTO Ministerial Conference of 2001 in Doha on November 14, 2001. It reaffirmed flexibility of TRIPS member states in circumventing patent rights for better access to essential medicines.

A compulsory license provides that the owner of a patent or copyright licenses the use of their rights against payment either set by law or determined through some form of adjudication or arbitration. In essence, under a compulsory license, an individual or company seeking to use another's intellectual property can do so without seeking the rights holder's consent, and pays the rights holder a set fee for the license. This is an exception to the general rule under intellectual property laws that the intellectual property owner enjoys exclusive rights that it may license—or decline to license—to others.

Test data exclusivity refers to protection of clinical trial data required to be submitted to a regulatory agency to prove safety and efficacy of a new drug, and prevention of generic drug manufacturers from relying on this data in their own applications. It provides a form of market exclusivity outside that provided by patent rights.

The pharmaceutical industry in India was valued at an estimated US$42 billion in 2021 and is estimated to reach $130 billion by 2030. India is the world's largest provider of generic medicines by volume, with a 20% share of total global pharmaceutical exports. It is also the largest vaccine supplier in the world by volume, accounting for more than 60% of all vaccines manufactured in the world. Indian pharmaceutical products are exported to various regulated markets including the US, UK, European Union and Canada.

The Campaign for Access to Essential Medicines is an international campaign started by Médecins Sans Frontières (MSF) to increase the availability of essential medicines in developing countries. MSF often has difficulties treating patients because the medicines required are too expensive or are no longer produced. Sometimes, the only drugs available are highly toxic or ineffective, and they often have to resort to inadequate testing methods to diagnose patients.

<span class="mw-page-title-main">James Love (NGO director)</span>

James Packard Love is the director of Knowledge Ecology International, formerly known as the Consumer Project on Technology, a non-governmental organization with offices in Washington, D.C., and Geneva, that works mainly on matters concerning knowledge management and governance, including intellectual property policy and practice and innovation policy, particularly as they relate to health care and access to knowledge.

<span class="mw-page-title-main">HIV/AIDS in Brazil</span>

The first AIDS case identified in Brazil was in 1982. Infection rates climbed exponentially throughout the 1980s, and in 1990 the World Bank famously predicted 1,200,000 cases by 2000, approximately double the actual number that was later reported by the Brazilian Ministry of Health and most international organizations. South and Southeast have 75% or more of this infection. The Northeast has 33% of the population but only 10% of AIDS.

Pharmaceutical policy is a branch of health policy that deals with the development, provision and use of medications within a health care system. It embraces drugs, biologics, vaccines and natural health products.

Legal scholars, economists, activists, policymakers, industries, and trade organizations have held differing views on patents and engaged in contentious debates on the subject. Critical perspectives emerged in the nineteenth century that were especially based on the principles of free trade. Contemporary criticisms have echoed those arguments, claiming that patents block innovation and waste resources that could otherwise be used productively, and also block access to an increasingly important "commons" of enabling technologies, apply a "one size fits all" model to industries with differing needs, that is especially unproductive for industries other than chemicals and pharmaceuticals and especially unproductive for the software industry. Enforcement by patent trolls of poor quality patents has led to criticism of the patent office as well as the system itself. Patents on pharmaceuticals have also been a particular focus of criticism, as the high prices they enable puts life-saving drugs out of reach of many people. Alternatives to patents have been proposed, such Joseph Stiglitz's suggestion of providing "prize money" as a substitute for the lost profits associated with abstaining from the monopoly given by a patent.

Medication costs, also known as drug costs are a common health care cost for many people and health care systems. Prescription costs are the costs to the end consumer. Medication costs are influenced by multiple factors such as patents, stakeholder influence, and marketing expenses. A number of countries including Canada, parts of Europe, and Brazil use external reference pricing as a means to compare drug prices and to determine a base price for a particular medication. Other countries use pharmacoeconomics, which looks at the cost/benefit of a product in terms of quality of life, alternative treatments, and cost reduction or avoidance in other parts of the health care system. Structures like the UK's National Institute for Health and Clinical Excellence and to a lesser extent Canada's Common Drug Review evaluate products in this way.

<span class="mw-page-title-main">TRIPS Agreement</span> International treaty on intellectual property protections

The Agreement on Trade-Related Aspects of Intellectual Property Rights (TRIPS) is an international legal agreement between all the member nations of the World Trade Organization (WTO). It establishes minimum standards for the regulation by national governments of different forms of intellectual property (IP) as applied to nationals of other WTO member nations. TRIPS was negotiated at the end of the Uruguay Round of the General Agreement on Tariffs and Trade (GATT) between 1989 and 1990 and is administered by the WTO.

The cost of HIV treatment is a complicated issue with an extremely wide range of costs due to varying factors such as the type of antiretroviral therapy and the country in which the treatment is administered. The first line therapy of HIV, or the initial antiretroviral drug regimen for an HIV-infected patient, is generally cheaper than subsequent second-line or third-line therapies. There is also a great variability of drug prices among low, middle, and high income countries. In general, low-income countries have the lowest cost of antiretroviral therapy, while middle- and high-income tend to have considerably higher costs. Certain prices of HIV drugs may be high and difficult to afford due to patent barriers on antiretroviral drugs and slow regulatory approval for drugs, which may lead to indirect consequences such as greater HIV drug resistance and an increased number of opportunistic infections. Government and activist movements have taken efforts to limit the price of HIV drugs.

South Africa's Medicines and Related Substance 1997 is a law enacted a compulsory license in order to fight HIV/AIDS epidemic. The intent of the Act was to reduce drug prices by allowing generic substitution of off-patent drugs, the parallel importation of on-patent drugs as well as price transparency.

The Medicines Patent Pool (MPP) is a Unitaid-backed international organisation founded in July 2010, based in Geneva, Switzerland. Its public health driven business model aims to lower the prices of HIV, tuberculosis and hepatitis C medicines and facilitate the development of better-adapted HIV treatments through voluntary licensing and patent pooling. Its goal is to improve access to affordable and appropriate HIV, hepatitis C and tuberculosis medicines in low- and middle-income countries (LMIC). In May 2020, the MPP become an implementing partner of the WHO's Covid-19 Technology Access Pool (C-TAP).

<span class="mw-page-title-main">Government Pharmaceutical Organization</span> State enterprise of Thailand

The Government Pharmaceutical Organization (GPO) is a Thai state enterprise which manufactures pharmaceutical products in Thailand. In 2011, the GPO netted a profit of 1.6 billion baht from the sale of pharmaceuticals and medical equipment. As of 2011, the GPO employed 2,812 persons. In 2016, the organization produced drugs at two government-owned factories.

At its essence, intellectual property rights are described as “a legal framework for contractual agreements concerning technologies, which encourage the institution of ‘markets for technology’, making easier the international transfer of technology and its diffusion at the local level.” The discussion that has taken place, concerning intellectual property rights and the following agreements, centers around spreading global knowledge and technologies. Intellectual property has been largely discussed and gone through a series of changes. At the globalized level, a global network for ideas led institutions to put policies in place and key players to form opposing viewpoints. Beyond intellectual property, alternative sources for innovation include forming partnerships and moving business activities abroad.

<span class="mw-page-title-main">Proprietary drug</span>

Proprietary drug are chemicals used for medicinal purposes which are formulated or manufactured under a name protected from competition through trademark or patent. The invented drug is usually still considered proprietary even if the patent expired. When a patent expires, generic drugs may be developed and released legally. Some international and national governmental organizations have set up laws to enforce intellectual property to protect proprietary drugs, but some also highlight the importance of public health disregarding legal regulations. Proprietary drugs affect the world in various aspects including medicine, public health and economy.

The TRIPS Agreement waiver is a joint intervention communication by South Africa and India to the TRIPS council of the World Trade Organization (WTO) on 2 October 2020.

<span class="mw-page-title-main">Priti Krishtel</span> Pharma lawyer + activist

Priti Krishtel is a lawyer and advocate for health justice and increased public participation in the patent system. She co-founded the United States-based nonprofit organization the Initiative for Medicines, Access, and Knowledge.

<span class="mw-page-title-main">Initiative for Medicines, Access, and Knowledge</span> Nonprofit organization

The Initiative for Medicines, Access, and Knowledge, known as I-MAK, is a U.S.-based global 501(c)(3) organization that advocates in the public interest for affordable access to medicines, and a medicines system that is more inclusive of patients and the public.

References

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  9. 1 2 3 4 5 6 7 8 Schüklenk, Udo; Ashcroft, Richard E. (April 2002). "Affordable Access to Essential Medication in Developing Countries: ConflictsBetween Ethical and Economic Imperatives". Journal of Medicine & Philosophy. 27 (2): 179–95. doi:10.1076/jmep.27.2.179.2989. PMID   11961696. S2CID   45453806.
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  13. ↑ "DELAURO HOLDS COMMITTEE HEARING ON PRESCRIPTION DRUGS UNCONSCIONABLE PRICE GOUGING IS IMPEDING CARE AND INCREASING OVERALL HEALTH CARE COSTS". States News Service. 2 December 2015.
  14. ↑ Godoy, Angelina Snodgrass (2015-06-01). "Market Myths and Assumptions: Examining the Transnational Politics of Access to Medicines Campaigning in Central America". Studies in Comparative International Development. 50 (2): 187–202. doi:10.1007/s12116-015-9184-4. ISSN   0039-3606. S2CID   155551996.
  15. ↑ Schaafsma, E. & Raynor, David & Berg, Lolkje. (2003). Accessing medication information by ethnic minorities: Barriers and possible solutions. Pharmacy world & science : PWS. 25. 185-90. 10.1023/A:1025812716177.
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  19. 1 2 "THE DOHA DECLARATION ON THE TRIPS AGREEMENT AND PUBLIC HEALTH". World Health Organization. Archived from the original on February 20, 2008. Retrieved 2018-03-07.
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  21. 1 2 Chung, Laura (Fall 2010). "Use of Paragraph 6 System for Access to Medicine". North Carolina Journal of International Law & Commercial Regulation. 36: 137–186.
  22. ↑ Abbas, Muhammad Z.; Riaz, Shamreeza (2017-11-24). "WTO "Paragraph 6" system for affordable access to medicines: Relief or regulatory ritualism?" (PDF). The Journal of World Intellectual Property. 21 (1–2): 32–51. doi:10.1111/jwip.12083. ISSN   1422-2213.
  23. ↑ Owoeye, Olasupo (2015). "International Patents Law and Public Health: Revisiting the TRIPS Compulsory Licensing Regime and the Doha Paragraph 6 System". European Intellectual Property Review. 37: 782–795.
  24. ↑ AFP Report (March 23, 2001). "Price cuts have little impact on access to AIDS drugs in Uganda" . Retrieved 2018-02-28.
  25. ↑ Chequer, P., Sudo, E.C., & Vitfria, M.A.A. (2000). The impact of anti-retroviral therapy in Brazil. Paper presented at International AIDS Conference in Durban, paper no. MoPpE1066.
  26. ↑ Norviel, Vern; Hoffmeister, David M. (September 30, 2015). "A Look At The Legality Behind Daraprim's Price Spike -". www.law360.com. Retrieved 2018-03-07.
  27. ↑ Muoio, Dave (September 17, 2015). "Daraprim price jump raises concerns among ID groups, providers". www.healio.com. Retrieved 2018-03-07.
  28. ↑ Schlanger, Zoë (2015-09-21). "Martin Shkreli on Raising Price of AIDS Drug 5,000 Percent: 'I Think Profits Are a Great Thing'". Newsweek. Retrieved 2018-03-07.
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  30. ↑ Directorate, Government of Canada, Health Canada, Health Products and Food Branch, Therapeutic Products (2004-07-26). "Introduction - Canada's Access to Medicines Regime". www.camr-rcam.gc.ca. Retrieved 10 February 2017.{{cite web}}: CS1 maint: multiple names: authors list (link)
  31. ↑ "About Us" . Retrieved 10 February 2017.
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  33. ↑ "Gavi's mission". www.gavi.org. Retrieved 2018-03-15.
  34. ↑ "Gavi's partnership model". www.gavi.org. Retrieved 2018-03-15.
  35. 1 2 Freeman, Michael; Hawkes, Sarah; Bennett, Belinda (March 2014). Law and global health. Freeman, Michael D. A.,, Hawkes, Sarah,, Bennett, Belinda. Oxford. ISBN   9780199688999. OCLC   881325330.{{cite book}}: CS1 maint: location missing publisher (link)
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