Access to medicines refers to the reasonable ability for people to get needed
medicines required to achieve
health
Health, according to the World Health Organization, is "a state of complete physical, mental and social well-being and not merely the absence of disease and infirmity".World Health Organization. (2006)''Constitution of the World Health Organiza ...
. Such access is deemed to be part of the
right to health
The right to health is the economic, social, and cultural right to a universal minimum standard of health to which all individuals are entitled. The concept of a right to health has been enumerated in international agreements which include the U ...
as supported by
international law
International law (also known as public international law and the law of nations) is the set of rules, norms, and standards generally recognized as binding between states. It establishes normative guidelines and a common conceptual framework for ...
since 1946.
The
World Health Organization
The World Health Organization (WHO) is a specialized agency of the United Nations responsible for international public health. The WHO Constitution states its main objective as "the attainment by all peoples of the highest possible level of h ...
states that
essential medicines should be available, of good quality, and accessible.
[ Reasonable access to medicines can be in conflict with ]intellectual property
Intellectual property (IP) is a category of property that includes intangible creations of the human intellect. There are many types of intellectual property, and some countries recognize more than others. The best-known types are patents, cop ...
and free markets. In the developing world
A developing country is a sovereign state with a lesser developed industrial base and a lower Human Development Index (HDI) relative to other countries. However, this definition is not universally agreed upon. There is also no clear agreem ...
people may not get treatment for conditions like HIV/AIDS
Human immunodeficiency virus infection and acquired immunodeficiency syndrome (HIV/AIDS) is a spectrum of conditions caused by infection with the human immunodeficiency virus (HIV), a retrovirus. Following initial infection an individual ...
.
Hindrances to access
Most hindrances to access revolve around market competition and lack of it.
Patent protection and exclusivity
Patent
A patent is a type of intellectual property that gives its owner the legal right to exclude others from making, using, or selling an invention for a limited period of time in exchange for publishing an enabling disclosure of the invention."A p ...
s provide an owner exclusive right
In Anglo-Saxon law, an exclusive right, or exclusivity, is a de facto, non-tangible prerogative existing in law (that is, the power or, in a wider sense, right) to perform an action or acquire a benefit and to permit or deny others the right to p ...
s 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. It is argued that patent protection
A patent is a type of intellectual property that gives its owner the legal right to exclude others from making, using, or selling an invention for a limited period of time in exchange for publishing an enabling disclosure of the invention."A p ...
allows pharmaceutical companies a monopoly
A monopoly (from Greek language, Greek el, μόνος, mónos, single, alone, label=none and el, πωλεῖν, pōleîn, to sell, label=none), as described by Irving Fisher, is a market with the "absence of competition", creating a situati ...
on particular drugs and processes.
Data exclusivity
Data exclusivity is a regulatory measure limiting the use of clinical trial
Clinical trials are prospective biomedical or behavioral research studies on human participants designed to answer specific questions about biomedical or behavioral interventions, including new treatments (such as novel vaccines, drugs, dietar ...
data and provides conductor of the trial temporary exclusive rights to the data. Many suggest that extending exclusivity periods can have consequences in delivering medication
A medication (also called medicament, medicine, pharmaceutical drug, medicinal drug or simply drug) is a drug used to diagnose, cure, treat, or prevent disease. Drug therapy (pharmacotherapy) is an important part of the medical field and re ...
, especially generic brand
Generic brands of consumer products (often supermarket goods) are distinguished by the absence of a brand name, instead identified solely by product characteristics and identified by plain, usually black-and-white packaging. Generally they imitat ...
s, to developing countries
A developing country is a sovereign state with a lesser developed industrial base and a lower Human Development Index (HDI) relative to other countries. However, this definition is not universally agreed upon. There is also no clear agreem ...
. However, extending patent terms can be reinvested for research and development
Research and development (R&D or R+D), known in Europe as research and technological development (RTD), is the set of innovative activities undertaken by corporations or governments in developing new services or products, and improving existi ...
and/or a source of funding for drug donations to low-income countries. Others suggest that data exclusivity works to diminish the availability of generic drug
A generic drug is a pharmaceutical drug that contains the same chemical substance as a drug that was originally protected by chemical patents. Generic drugs are allowed for sale after the patents on the original drugs expire. Because the active ch ...
s. 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.
Cost
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. It is argued that competition is necessary to lower drug prices and improve access to affordable medications.
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. It is argued that pharmaceutical companies have dramatically increased prices for treatments that are essential in treating diseases such as HIV/AIDS
Human immunodeficiency virus infection and acquired immunodeficiency syndrome (HIV/AIDS) is a spectrum of conditions caused by infection with the human immunodeficiency virus (HIV), a retrovirus. Following initial infection an individual ...
, hepatitis C
Hepatitis C is an infectious disease caused by the hepatitis C virus (HCV) that primarily affects the liver; it is a type of viral hepatitis. During the initial infection people often have mild or no symptoms. Occasionally a fever, dark urine, a ...
, and cancer
Cancer is a group of diseases involving abnormal cell growth with the potential to invade or spread to other parts of the body. These contrast with benign tumors, which do not spread. Possible signs and symptoms include a lump, abnormal b ...
.
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. 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. However, low-income countries often lack the essential infrastructure
Infrastructure is the set of facilities and systems that serve a country, city, or other area, and encompasses the services and facilities necessary for its economy, households and firms to function. Infrastructure is composed of public and priv ...
to allow for generic brand production. 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. 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. It also argued that international aid
In international relations, aid (also known as international aid, overseas aid, foreign aid, economic aid or foreign assistance) is – from the perspective of governments – a voluntary transfer of resources from one country to another.
Ai ...
, state investment, and measures for infection prevention are necessary to allow for generic brand production in low-income countries.
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.
Legislation
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
The World Trade Organization (WTO) is an intergovernmental organization that regulates and facilitates international trade. With effective cooperation
in the United Nations System, governments use the organization to establish, revise, and e ...
(WTO), effective January 1995. This agreement introduced global standards for enforcing and protecting nearly all forms of intellectual property rights
Intellectual property (IP) is a category of property that includes intangible creations of the human intellect. There are many types of intellectual property, and some countries recognize more than others. The best-known types are patents, cop ...
(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
Enforcement is the proper execution of the process of ensuring compliance with laws, regulations, rules, standards, and social norms.
Governments attempt to effectuate successful implementation of policies by enforcing laws and regulations.
Ena ...
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. 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
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 ...
, which permits the manufacture of generic brands of patented drugs, at prices set in a competitive market in cases of national emergencies. For example, many believe that the HIV/AIDs crisis in Africa
Africa is the world's second-largest and second-most populous continent, after Asia in both cases. At about 30.3 million km2 (11.7 million square miles) including adjacent islands, it covers 6% of Earth's total surface area ...
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
Doha Declaration
Further legislation such as Doha Declaration of 2001 worked to rectify the negative impact of the TRIPS Agreement. 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
The human immunodeficiency viruses (HIV) are two species of ''Lentivirus'' (a subgroup of retrovirus) that infect humans. Over time, they cause acquired immunodeficiency syndrome (AIDS), a condition in which progressive failure of the immune ...
, tuberculosis
Tuberculosis (TB) is an infectious disease usually caused by '' Mycobacterium tuberculosis'' (MTB) bacteria. Tuberculosis generally affects the lungs, but it can also affect other parts of the body. Most infections show no symptoms, in ...
, and malaria
Malaria is a mosquito-borne infectious disease that affects humans and other animals. Malaria causes symptoms that typically include fever, tiredness, vomiting, and headaches. In severe cases, it can cause jaundice, seizures, coma, or death. S ...
. 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. 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
Public health is "the science and art of preventing disease, prolonging life and promoting health through the organized efforts and informed choices of society, organizations, public and private, communities and individuals". Analyzing the det ...
issues.
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. This is known as the paragraph 6 system. 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.
Differences by geography
Africa
There is estimated to be more than 4 million HIV infected individuals in South Africa
South Africa, officially the Republic of South Africa (RSA), is the southernmost country in Africa. It is bounded to the south by of coastline that stretch along the South Atlantic and Indian Oceans; to the north by the neighbouring countri ...
. Out of this, only 10,000 individuals are able to afford access to essential AIDS medications at their current prices. In Malawi
Malawi (; or aláwi Tumbuka: ''Malaŵi''), officially the Republic of Malawi, is a landlocked country in Southeastern Africa that was formerly known as Nyasaland. It is bordered by Zambia to the west, Tanzania to the north and northeast ...
, out of one million infected individuals, 30 have access to life-sustaining essential AIDS medications. In Uganda
}), is a landlocked country in East Africa
East Africa, Eastern Africa, or East of Africa, is the eastern subregion of the African continent. In the United Nations Statistics Division scheme of geographic regions, 10-11-(16*) territor ...
, out of the estimated 820,000 infected individuals, only about 1.2% can afford essential AIDS medications.
Latin America
There is estimated to be 1.8 million individuals HIV infected individuals in the Latin America
Latin America or
* french: Amérique Latine, link=no
* ht, Amerik Latin, link=no
* pt, América Latina, link=no, name=a, sometimes referred to as LatAm is a large cultural region in the Americas where Romance languages — languages derived f ...
n region. Brazil is argued to be one of the most affected by the AIDS epidemic
The global epidemic of HIV/AIDS (human immunodeficiency virus infection and acquired immunodeficiency syndrome) began in 1981, and is an ongoing worldwide public health issue. According to the World Health Organization (WHO), as of 2021, HIV/AI ...
. There is also a high prevalence of HIV in smaller countries such as Guatemala
Guatemala ( ; ), officially the Republic of Guatemala ( es, República de Guatemala, links=no), is a country in Central America. It is bordered to the north and west by Mexico; to the northeast by Belize and the Caribbean; to the east by H ...
, Honduras
Honduras, officially the Republic of Honduras, is a country in Central America. The republic of Honduras is bordered to the west by Guatemala, to the southwest by El Salvador, to the southeast by Nicaragua, to the south by the Pacific Oce ...
, and Belize
Belize (; bzj, Bileez) is a Caribbean and Central American country on the northeastern coast of Central America. It is bordered by Mexico to the north, the Caribbean Sea to the east, and Guatemala to the west and south. It also shares a wate ...
. 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%.
India
Many Indian families live below the poverty line due to healthcare expenses. From 1972 to 2005, due to a lack of patent laws
A patent is a type of intellectual property that gives its owner the legal right to exclude others from making, using, or selling an invention for a limited period of time in exchange for publishing an enabling disclosure of the invention."A p ...
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.
Differences by sector
Vaccines
The majority of deaths from vaccine-preventable diseases A vaccine-preventable disease is an infectious disease for which an effective preventive vaccine exists. If a person acquires a vaccine-preventable disease and dies from it, the death is considered a vaccine-preventable death.
The most common and s ...
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
A vaccine is a biological Dosage form, preparation that provides active acquired immunity to a particular infectious disease, infectious or cancer, malignant disease. The safety and effectiveness of vaccines has been widely studied and verifie ...
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
The ''Haemophilus influenzae'' type B vaccine, also known as Hib vaccine, is a vaccine used to prevent ''Haemophilus influenzae'' type b (Hib) infection. In countries that include it as a routine vaccine, rates of severe Hib infections have d ...
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
Cervical cancer is a cancer arising from the cervix. It is due to the abnormal growth of cells that have the ability to invade or spread to other parts of the body. Early on, typically no symptoms are seen. Later symptoms may include abnormal ...
are in developing countries.
Epidemics and access
HIV/AIDs
The appearance of generic manufacturers in low-income countries, such as India
India, officially the Republic of India (Hindi: ), is a country in South Asia. It is the seventh-largest country by area, the second-most populous country, and the most populous democracy in the world. Bounded by the Indian Ocean on the so ...
and Brazil
Brazil ( pt, Brasil; ), officially the Federative Republic of Brazil (Portuguese: ), is the largest country in both South America and Latin America. At and with over 217 million people, Brazil is the world's fifth-largest country by area ...
, 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
The management of HIV/AIDS normally includes the use of multiple antiretroviral drugs as a strategy to control HIV infection. There are several classes of antiretroviral agents that act on different stages of the HIV life-cycle. The use of multipl ...
drugs' prices dropped by more than 99%, from $10,000/year per patient in 2000 to less than $70 in 2014.
Daraprim
On August 10, 2015, Turing Pharmaceuticals
Vyera Pharmaceuticals (formerly Turing Pharmaceuticals) is a pharmaceutical company incorporated in Zug, Switzerland, with offices in New York City. The company started to do business in the US as Vyera Pharmaceuticals in September 2017.
The com ...
, a pharmaceutical company owned by Martin Shkreli, purchased the rights to a Daraprim. Daraprim, an anti-parasitic and anti-malarial
Antimalarial medications or simply antimalarials are a type of antiparasitic chemical agent, often naturally derived, that can be used to treat or to prevent malaria, in the latter case, most often aiming at two susceptible target groups, young c ...
drug, is considered an essential drug for HIV treatments. It is widely used to treat patients with AIDS-related and AIDs-unrelated toxoplasmosis
Toxoplasmosis is a parasitic disease caused by ''Toxoplasma gondii'', an apicomplexan. Infections with toxoplasmosis are associated with a variety of neuropsychiatric and behavioral conditions. Occasionally, people may have a few weeks or months ...
. 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.
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. 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.
Médecins Sans Frontières has had such a campaign since 1999 known as the Campaign for Access to Essential Medicines
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 becaus ...
.
In Tanzania
Tanzania (; ), officially the United Republic of Tanzania ( sw, Jamhuri ya Muungano wa Tanzania), is a country in East Africa within the African Great Lakes region. It borders Uganda to the north; Kenya to the northeast; Comoro Islands and ...
, 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
The Bill & Melinda Gates Foundation (BMGF), a merging of the William H. Gates Foundation and the Gates Learning Foundation, is an American private foundation founded by Bill Gates and Melinda French Gates. Based in Seattle, Washington, it was l ...
. It worked to create a nationwide chain of dispensers, which provide quality pharmaceutical drugs and services to its citizens.
The GAVI
GAVI, officially Gavi, the Vaccine Alliance (previously the GAVI Alliance, and before that the Global Alliance for Vaccines and Immunization) is a public–private global health partnership with the goal of increasing access to immunization ...
vaccination alliance is an international public-private partnership, created in 2000, devoted to improving access to vaccines in low-income countries. 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
The World Health Organization (WHO) is a specialized agency of the United Nations responsible for international public health. The WHO Constitution states its main objective as "the attainment by all peoples of the highest possible level of h ...
, UNICEF
UNICEF (), originally called the United Nations International Children's Emergency Fund in full, now officially United Nations Children's Fund, is an agency of the United Nations responsible for providing Humanitarianism, humanitarian and Devel ...
, the World Bank
The World Bank is an international financial institution that provides loans and grants to the governments of low- and middle-income countries for the purpose of pursuing capital projects. The World Bank is the collective name for the Interna ...
, the Bill & Melinda Gates Foundation
The Bill & Melinda Gates Foundation (BMGF), a merging of the William H. Gates Foundation and the Gates Learning Foundation, is an American private foundation founded by Bill Gates and Melinda French Gates. Based in Seattle, Washington, it was l ...
and other private philanthropists. 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.
In Kenya
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, 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. 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. It also calls for pharmaceutical companies to reduce the price of their medications. 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.
See also
*WHO Model List of Essential Medicines
The WHO Model List of Essential Medicines (aka Essential Medicines List or EML), published by the World Health Organization (WHO), contains the medications considered to be most effective and safe to meet the most important needs in a health ...
*Access to Medicine Index
The Access to Medicine Index is a ranking system published biennially since 2008 by the Access to Medicine Foundation in Amsterdam, the Netherlands, an international not-for-profit organisation, funded by the Dutch Ministry of Foreign Affairs, the ...
References
{{Reflist
World Health Organization