IN A NUTSHELL Author's noteEssential medicines are medicines that meet the health needs of the country's population and should always be available in sufficient quantities, in the appropriate dosage form and at an affordable price. The World Health Organization WHO has been compiling the model list[i] since 1977 and updating it every two years. Each country should adapt it to its needs. Access to essential medicines in Africa, Latin America and Asia is inadequate. Economic, political, infrastructural and social aspects mean that many people in these countries have no or only insufficient access to essential medicines
By Dr. med. Christiane Fischer
Chairwoman, PHM Deuteschland
Inadequate Access to Essential Medicines in Poor Countries
Challenges in accessing essential medicines
Patents
Patents are a major driver of high drug prices and a major obstacle to access in the global south. The minimum requirements for a product to qualify for a patent are: it must be new, manufacturable by industry and innovative. This is regulated by an agreement of the World Trade Organization (WTO), the Agreement on the Protection of Intellectual Property Rights (TRIPS). However, the agreement does not regulate when a product is considered innovative.
The World Trade Organization WTO has existed since 1994. Since then, there has been 20 years of patent protection on all products, including medicines. During this time, the company has a temporary monopoly. As with any monopoly, this leads to price increases and a shortage of supply. Patent protection applies in all WTO member states, although there are exceptions for the least developed countries (LDCs). Since January 1, 2005, developing countries that are not LDCs have had to implement the provisions of the TRIPS agreement and grant full product patent protection for medicines. This also includes India, the country with the largest pharmaceutical production in the world. Without India, almost all African countries would not be able to be supplied. In the case of vaccines or antiretroviral drugs (ARVs) that are effective against HIV, this means that many people in poor countries, especially in most African countries, do not have access to these drugs or do not have access to them in sufficient quantities. The problem also affects other drugs.
Many unnecessary patents are also granted in many African countries. Indian patent law, on the other hand, prohibits such patents on so-called marginal innovations. Therefore, many drugs can be exported from India but not imported into African countries.
In India there are also many local production capacities for drugs. They mostly produce generic drugs. India is also known as the pharmacy of the poor. In Africa, local production facilities exist almost exclusively in South Africa. Many countries in these regions have only limited capacity to produce drugs locally, which leads to a strong dependence on imported drugs. A transfer of technology and knowledge to develop local production is urgently needed.
Other reasons for high drug costs
Many countries in Africa, Latin America and Asia have limited financial resources and cannot purchase expensive essential medicines. This particularly affects patented medicines. But high prices on medicines also arise when there is only one manufacturer, creating a quasi-monopoly. These are then referred to as neglected medicines. High poverty rates in these regions are an additional factor and mean that many people cannot afford the medicines they need. Health insurance hardly exists and people have to finance most expenses out of their own pockets.
Some diseases, such as multiple sclerosis, are less common or less diagnosed in these countries. The prices of medicines that are supposed to work against these diseases are unrealistically high. Most people cannot afford the medicines. The World Health Organization (WHO) has included three MS drugs in its model list of essential medicines for the first time in 2023. But their effectiveness is limited. The critical organization LinienWatch, which checks guidelines for conflicts of interest, gives the guidelines published by the Society of Neurology only a mediocre rating, awarding them ten out of a possible 18 points.[ii]
The overpriced drugs also have very problematic side effects. Cladribine (a single 10 mg tablet costs €2,663) carries the risk of serious liver damage, as Merck Healthcare Germany admits in a Red Hand Letter.[iii] Glatiramer acetate (30 pre-filled syringes cost €1,426.96) can also lead to acute liver failure. And rituximab (in Germany you pay €1,085.70 for an infusion bottle) can lead to serious immune deficiencies, warns the Drug Commission of the German Medical Association.[iv]
Infrastructure problems
Infrastructure problems also exist in many poor countries. Unreliable supply chains can lead to bottlenecks and delays in the delivery of medicines. Lack of infrastructure for the safe storage and transport of medicines exists particularly in remote or rural areas. In villages there are often no refrigerators, so many medicines cannot be cooled and therefore cannot be used. This affects HIV medicines and vaccines, among others.[v]
Overly strict or inefficient regulatory processes and corruption also hinder access to new and important medicines. However, there is a risk that the argument will be misused by the pharmaceutical industry to justify why essential medicines do not reach those affected.
Lack of education, insufficient knowledge and problematic awareness about the correct use of medicines exist. They are often just an excuse to keep people away from essential medicines.
Strategies to improve access
There are many strategies in poor countries to improve access to essential medicines. These include strengthening health systems, improving the infrastructure for storing and transporting medicines, and developing efficient and transparent supply chains.
Providing financial assistance to poor population groups is essential to enable them to access essential medicines. A successful example is that in the Indian state of Tamil Nadu, essential medicines are made available to everyone free of charge in the public health sector.[vi]
A ban on patents on medicines would make medicines more affordable. On October 2, 2020, India and South Africa submitted a request to the World Trade Organization (WTO) to at least temporarily suspend patent protection for all products that are necessary for the prevention, containment and treatment of Covid-19. In WTO language, such an exception is called a “waiver”. This request failed mainly due to resistance from wealthy countries, including the USA, Great Britain and Germany.[vii]
Success stories and initiatives
International cooperation, local initiatives and innovative approaches are crucial to tackling the health challenges in these regions. Successful examples include:
Global Fund to Fight AIDS, Tuberculosis and Malaria: A financing instrument against major infections. The global fund provides the financial means to fight these diseases and has thus improved access to medicines in many affected countries. [viii]
Gavi, the Vaccine Alliance: Gavi has successfully improved access to life-saving vaccines in developing countries. Since its founding in 2000, Gavi has promoted the vaccination of 760 million children against life-threatening diseases such as diphtheria, tetanus and whooping cough, thus preventing around 13 million deaths. [ix]
The Medicines Patent Pool (MPP) is committed to improving the health of people in low- and middle-income countries. It is part of the United Nations. It improves access to high-quality, safe, effective, appropriate and affordable medicines, especially for the treatment of HIV/AIDS and tuberculosis. To do this, MPP negotiates with patent holders to put their intellectual property into the pool. MPP then grants licenses to facilitate the production of affordable generics.[x]
References
[i] WHO, WHO Model Lists of Essential Medicines, 2023
[ii] https://www.leitlinienwatch.de/diagnose-und-therapie-der-multiplen-sklerose-neuromyelitis-optica-spectrum-erkrankungen-und-mog-igg-assoziierten-erkrankungen-2/ (10.6.2024)
[iii] Merck Healthcare Germany , Mavenclad ® (Cladribin-Tabletten): Risiko von schwerwiegendenn Leberschäden und neue Empfehlungen zur Überwachung der Leberfunktion, 16.02.2022 https://www.akdae.de/fileadmin/user_upload/akdae/Arzneimittelsicherheit/RHB/Archiv/2022/20220216.pdf (10.6.2024)
[iv] WHO endorses landmark public health decisions on Essential Medicines for Multiple Sclerosis, 2023
https://www.who.int/news/item/26-07-2023-who-endorses-landmark-public-health-decisions-on-essential-medicines-for-multiple-sclerosis (10.6.2024)
DMSG, WHO nahm drei MS-Medikamente in Liste der unentbehrlichen Arzneimittel auf, 2023
https://www.dmsg-berlin.de/aktuelles/detailansicht/who-nahm-drei-ms-medikamente-in-liste-der-unentbehrlichen-arzneimittel-auf-355 (10.6.2024)
U Rosien, Akutes Leberversagen unter Glatirameracetat, Arzneiverordnung in der Praxis 1/2016
https://www.akdae.de/arzneimitteltherapie/arzneiverordnung-in-der-praxis/ausgaben-archiv/ausgaben-ab-2015/ausgabe/artikel?tx_lnsissuearchive_articleshow%5Baction%5D=show&tx_lnsissuearchive_articleshow%5Barticle%5D=4431&tx_lnsissuearchive_articleshow%5Bcontroller%5D=Article&tx_lnsissuearchive_articleshow%5Bissue%5D=9&tx_lnsissuearchive_articleshow%5Byear%5D=2016&cHash=92b896421c776b703a6127464f5c4b68 (10.6.2024)
AKDÄ, Schwere Immundefekte nach Behandlung mit Rituximab
Deutsches Ärzteblatt, Jg. 115, Heft 49, 07.12.20
https://www.akdae.de/arzneimittelsicherheit/bekanntgaben/newsdetail/schwere-immundefekte- 2015nach-behandlung-mit-rituximab-aus-der-uaw-datenbank (10.6.2024)
The prices refer to the German Red List 2023
[v] MSF, Empty Shelves Come Back Tomorrow,
https://www.aerzte-ohne-grenzen.at/sites/default/files/attachments/empty_shelves_report_low.pdf (10.6.2024)
[vi] NHM. Free Drugs Service Initiative
https://nhm.gov.in/index1.php?lang=1&level=2&sublinkid=1218&lid=192 (10.6.2024)
[vii] Paritätischer Wohlfahrtsverband ,Paritätisches Positionspapier Patente für Covid-19 relevante medizinische Produkte und Technologien aussetzen, Menschen weltweit schützen” 2020
https://www.der-paritaetische.de/alle-meldungen/paritaetisches-positionspapier-zur-aussetzung-des-patentschutzes-fuer-imfpstoffe-gegen-das-corona-virus/ (10.6.2024)
[viii]https://www.theglobalfund.org/en/ (10.6.2024)
[ix] https://www.gavi.org/ (10.6.2024)
[x] https://medicinespatentpool.org/ (10.6.2024)
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