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Access to medicines

From Wikipedia, the free encyclopedia

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]

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

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

Patent protection and exclusivity

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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

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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

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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

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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

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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

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Logo of the World Trade Organization (WTO)

Trips agreement

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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

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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

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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]

Voluntary Licensing

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Another mechanism to enable access to essential medicines in low- and middle-income countries (LMICs) is a voluntary license (VL).[24] A VL is an agreement where an originator manufacturer allows a generic manufacturer to produce and sell a patented drug in specific countries under certain terms. These licences can be established directly between patent holders and generic manufacturers or through patent pooling mechanisms like the Medicines Patent Pool. Such licences, are often non-exclusive and granted to multiple manufacturers.[25] A study in The Lancet suggest that voluntary licensing was an effective tool in advancing access to Hepatitis C antiviral medicines.[26] VL has also been effective in increasing access to HIV medicines in the development world via the Medicines Patent Pool.[27] On the hand there are groups critical of voluntary licensing including Médecins Sans Frontières (MSF).[28]

Differences by geography

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

Africa

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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.[29]

Latin America

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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.[30] 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

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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

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Vaccines

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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

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HIV/AIDS

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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]

Civil society organizations in India, led by the Sankalp Rehabilitation Trust, are opposing Gilead Sciences' patent applications for the HIV drug lenacapavir.[31] They argue that allowing generic competition is essential for making the long-acting drug affordable in middle-income countries.[32] Lenacapavir, a twice-yearly injection, has shown strong potential for HIV prevention, offering hope for ending AIDS if widely accessible. The Indian Patent Office will hear the Trust’s objections on September 19. The Trust claims that two of Gilead’s patent applications, concerning salt forms of the drug, lack true innovation.[33]

Gilead Sciences has agreed to voluntary licensing deals allowing companies to produce generic versions of its HIV drug, lenacapavir, for 120 low- and lower-middle-income countries.[34][35] This decision follows clinical trials showing the drug’s effectiveness in preventing HIV, particularly as a twice-yearly injectable, which could address the challenges of daily pill adherence and stigma.

Malaria

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Structure of 5-(4-chlorophenyl)-6-ethylpyrimidine-2,4-diamine
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.[36] 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.[37] 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.[38]

Tuberculosis (TB)

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Johnson & Johnson announced 2023 that it did not intend to enforce its patents bedaquiline for the treatment of multidrug-resistant TB in 134 LMIC countries.[39] Johnson & Johnson also granted Stop TB Partnership´s Global Drug Facility`s a license that enabled the tender, procurement and supply of generic versions of bedaquiline.[40]

Campaigns

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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.[41] 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.[42]

Médecins Sans Frontières has had such a campaign since 1999 known as the Campaign for Access to Essential Medicines.[43] On June 20, 2024, MSF announced closing down its Access-to-medicines campaign focused on enabling access to medicines in resource limited settings.[44] MSF plans to replace the campaign with a new effort that will focus on products, like medicines and vaccines, that MSF needs for its own relief efforts.[44] Several advocates have criticized this move including the Treatment Action Group.[45]

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.[46]

The GAVI vaccination alliance is an international public-private partnership, created in 2000, devoted to improving access to vaccines in low-income countries.[47] 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.[48] 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.[49] 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.[50] It also calls for pharmaceutical companies to reduce the price of their medications.[51] 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.[49]

See also

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References

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  1. ^ "WHO Access to medicines". www.who.int. Archived from the original on March 7, 2014. Retrieved 2017-02-10.
  2. ^ a b "Access to essential medicines as part of the right to health". World Health Organization. Archived from the original on January 10, 2014. Retrieved 10 February 2017.
  3. ^ "Final Report High-Level Panel on Access to Medicines". Retrieved 10 February 2017.
  4. ^ Moon, Suerie (9 February 2017). "Powerful Ideas for Global Access to Medicines". New England Journal of Medicine. 376 (6): 505–507. doi:10.1056/NEJMp1613861. PMID 28099819.
  5. ^ Leevy, T. (2006-12-01). "Intellectual Property and Access to Medicine for the Poor". Virtual Mentor. 8 (12). Leevy, Tara: 834–838. doi:10.1001/virtualmentor.2006.8.12.hlaw1-0612. PMID 23241543.
  6. ^ a b c d Diependaele, Lisa; Cockbain, Julian; Sterckx, Sigrid (April 2017). "Raising the Barriers to Access to Medicines in the Developing World – The Relentless Push for Data Exclusivity". Developing World Bioethics. 17 (1): 11–21. doi:10.1111/dewb.12105. PMC 5347964. PMID 26818105.
  7. ^ M.D., Robert Pearl. "Why Patent Protection In The Drug Industry Is Out Of Control". Forbes. Retrieved 2018-03-07.
  8. ^ a b c Stevens, Hilde; Huys, Isabelle (2017). "Innovative Approaches to Increase Access to Medicines in Developing Countries". Frontiers in Medicine. 4: 218. doi:10.3389/fmed.2017.00218. PMC 5725781. PMID 29270407.
  9. ^ a b c d e f g h 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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  12. ^ Weiss, Shira (2017-03-01). "The Ethics of Price Gouging". Journal of Religious Ethics. 45 (1): 142–163. doi:10.1111/jore.12171. ISSN 1467-9795.
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  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.
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  16. ^ "WTO | intellectual property - overview of TRIPS Agreement". www.wto.org. Retrieved 2018-03-07.
  17. ^ "WTO AND THE TRIPS AGREEMENT". World Health Organization. Archived from the original on May 2, 2007. Retrieved 2018-03-07.
  18. ^ a b Cohen-Kohler, J C (2007-11-01). "The Morally Uncomfortable Global Drug Gap". Clinical Pharmacology & Therapeutics. 82 (5): 610–614. doi:10.1038/sj.clpt.6100359. ISSN 1532-6535. PMID 17898710. S2CID 12003036.
  19. ^ a b "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.
  20. ^ "WTO | Glossary - Paragraph 6 system". www.wto.org. Retrieved 2018-04-27.
  21. ^ a b 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. ^ Erickson, Elise. "VOLUNTARY LICENSING". Knowledge Portalia. Geneva Graduate Institute: Global Health Centre. Retrieved 7 July 2024.
  25. ^ "Voluntary licenses and non-assert declarations". IFPMA. Retrieved 7 July 2024.
  26. ^ Simmons, Bryony; Cooke, Graham S; Miraldo, Marisa (September 2019). "Effect of voluntary licences for hepatitis C medicines on access to treatment: a difference-in-differences analysis". The Lancet Global Health. 7 (9): e1189–e1196. doi:10.1016/S2214-109X(19)30266-9. PMID 31362914.
  27. ^ Juneja, Sandeep; Gupta, Aastha; Moon, Suerie; Resch, Stephen (2017-05-25). "Projected savings through public health voluntary licences of HIV drugs negotiated by the Medicines Patent Pool (MPP)". PLOS ONE. 12 (5): e0177770. Bibcode:2017PLoSO..1277770J. doi:10.1371/journal.pone.0177770. ISSN 1932-6203. PMC 5444652. PMID 28542239.
  28. ^ "Voluntary licenses and access to medicines". Médecins Sans Frontières (MSF).
  29. ^ AFP Report (March 23, 2001). "Price cuts have little impact on access to AIDS drugs in Uganda". Retrieved 2018-02-28.
  30. ^ 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.
  31. ^ "Civil Society Organisations oppose Gilead's patent applications for lenacapavir in India". www.pharmabiz.com. Retrieved 2024-09-17.
  32. ^ Perappadan, Bindu Shajan (2024-09-17). "Patent applications for HIV prevention drug opposed in India". The Hindu. ISSN 0971-751X. Retrieved 2024-09-18.
  33. ^ Thacker, Teena (2024-09-17). "Activists sound alarm bells as Gilead seeks rights over HIV drug". The Economic Times. ISSN 0013-0389. Retrieved 2024-09-18.
  34. ^ "Gilead Signs Royalty-Free Voluntary Licensing Agreements with Six Generic Manufacturers to Increase Access to Lenacapavir for HIV Prevention in High-Incidence, Resource-Limited Countries". www.gilead.com. Retrieved 2024-10-02.
  35. ^ Silverman, Ed (2024-10-02). "Gilead strikes voluntary licensing deals in poor countries for its pricey HIV drug". STAT. Retrieved 2024-10-02.
  36. ^ 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.
  37. ^ Muoio, Dave (September 17, 2015). "Daraprim price jump raises concerns among ID groups, providers". www.healio.com. Retrieved 2018-03-07.
  38. ^ 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.
  39. ^ Becker, Zoey. "Johnson & Johnson says it won't enforce secondary patents on tuberculosis med Sirturo". Fierce Pharma. Retrieved 12 July 2024.
  40. ^ "Johnson & Johnson Confirms Intent Not to Enforce Patents for SIRTURO® (bedaquiline) for the Treatment of Multidrug-Resistant Tuberculosis in 134 Low- and Middle-Income Countries". JnJ. 29 September 2023.
  41. ^ Directorate, Government of Canada, Health Canada, Health Products and Food Branch, Therapeutic Products (2004-07-26). "Canada's Access to Medicines Regime". www.camr-rcam.gc.ca. Retrieved 10 February 2017.{{cite web}}: CS1 maint: multiple names: authors list (link)
  42. ^ 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)
  43. ^ "About Us". Retrieved 10 February 2017.
  44. ^ a b Silverman, Ed (20 June 2024). "Doctors Without Borders is closing its widely regarded access-to-medicines campaign". STAT News.
  45. ^ Harrington, Mark (20 June 2024). "An Open Letter to Médecins Sans Frontières — Urgent Call to Reverse the Devastating Decision to Shutter the MSF Access Campaign". Treatment Action Group.
  46. ^ Mbwasi, Romuald; Mlaki, Wilson (2008). "Increasing access to medicines in Tanzania". The Lancet. 372 (9634): 205–206. doi:10.1016/s0140-6736(08)61070-3. PMID 18640453. S2CID 6129570.
  47. ^ "Gavi's mission". www.gavi.org. Retrieved 2018-03-15.
  48. ^ "Gavi's partnership model". www.gavi.org. Retrieved 2018-03-15.
  49. ^ a b 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)
  50. ^ "WTO | Managing the Challenges of WTO Participation: Case Study". www.wto.org. Retrieved 2018-03-15.
  51. ^ "Lobby Petitions Government, Pharmaceutical Companies". Africa News Service. September 23, 2003.
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