Word

Definition

Antiretroviral (ARV)

Antiretrovirals (ARVs) are used for the treatment of HIV/AIDS. An ARV regimen usually consists of multiple ARVs, which are sometimes co-formulated into one pill as a ‘fixed-dose combination’ or FDC.

Compulsory licence

Compulsory licences can be granted by authorities to an entity other than a patent holder to produce a given product that is patented in exchange for ‘adequate remuneration’. The ability of governments to issue compulsory licences is one of several flexibilities enshrined in the World Trade Organization’s TRIPS Agreement (Trade-Related Aspects of Intellectual Property Rights) and reiterated in the 2001 Doha Declaration on TRIPS and Public Health.

Direct-acting antivirals

Direct-acting antivirals (DAAs) are used to treat hepatitis C. DAAs are molecules that target specific proteins of the hepatitis C virus (HCV), thereby disrupting viral replication. Recent DAAs have revolutionised the way hepatitis C is treated, enabling all-oral regimens combining highly effective DAAs of different classes. Such interferon-free regimens could cure hepatitis C within a short course of treatment. More information

HIV drug resistance (HIVDR)

As defined by the WHO, the ability of HIV to mutate and reproduce itself in the presence of antiretroviral drugs is called HIV drug resistance (HIVDR). The consequences of HIVDR include treatment failure and further spread of drug resistant HIV. This can compromise the effectiveness of the limited therapeutic options to reach the last 90 target (of achieving viral suppression) and further reduce HIV incidence, mortality and morbidity. More information

First-line antiretroviral therapy (ART)

Antiretroviral therapy (ART) is treatment of people infected with human immunodeficiency virus (HIV) using anti-HIV drugs. The standard treatment consists of a combination of at least three drugs (often called ‘highly active antiretroviral therapy’ or HAART) that suppress HIV replication. Three drugs are used, to reduce the likelihood of the virus developing resistance. ART has the potential both to reduce mortality and morbidity rates among HIV-infected people, and to improve their quality of life. If the virus develops resistance, the patient needs to be switched to a ‘second-line’ regimen, consisting of effective ARVs. More information

Fixed-dose combination (FDC)

A fixed-dose combination (FDC) contains two or more medicines combined into one pill, simplifying treatment for patients and medical staff alike. FDCs could help patients better adhere to their treatment, reduce the risk of acquired drug resistance as a result of non-compliance, and simplify procurement. FDCs for HIV/AIDS were largely pioneered by Indian generic manufacturers, and have played a key role in helping extend treatment to millions of people living with HIV/AIDS in developing countries. While FDCs for older generations of ARV exist, optimal combinations containing newer HIV medicines are needed. Appropriately formulated FDCs are urgently needed for children with HIV. We help facilitate the development of newer FDCs.

Generic medicine

A generic medicine is a drug that is therapeutically equivalent to an originator product in dosage, efficacy, route of administration and intended use.

Licence

An agreement in which a patent holder allows another party to make, use, or sell the invention.

Licensor

The patent holder that grants the licence (for example, a pharmaceutical company, university, or public research institution).

Licensee

The entity that receives a licence to use a patent (for example, the MPP, a generic drug manufacturer or drug developer).

Multidrug-resistant tuberculosis

Multidrug-resistant tuberculosis (MDR-TB) is a form of tuberculosis caused by bacteria that do not respond to at least isoniazid and rifampicin – key components of the WHO-recommended first-line TB treatment. More information

Sublicence

A sublicence is an agreement in which a licensee (for example, the MPP) grants licensed rights to an eligible third party (for example, a generic drug manufacturer or drug developer).

Non-exclusive licence

A non-exclusive licence is a licence that can be granted to more than one entity. For example, a patent holder can grant non-exclusive licences to multiple generic drug manufacturers.

Voluntary licence

A voluntary licence is a voluntary agreement reached between the patent holder (licensor) and the licensee. Terms and conditions of such a licence are agreed between the patent holder and licensee, and can specify in which countries a medicine can be sold and what the royalty will be. The MPP is a mechanism that manages voluntary licences between multiple licensors and licensees.

Originator medicine

An originator medicine is one that is produced by the patent holder of the medicine in question.

Paediatric formulations

Paediatric formulations are versions of medicines that have been developed specifically for children. The MPP is helping facilitate the development of World Health Organization-recommended therapies for children through the Paediatric HIV Treatment Initiative.

Patent

The right to prevent anyone else from making, using or selling the patented invention. It is granted by a government or regional authority. A patent term typically lasts for 20 years, which means that during that period of time, the patent holder has a monopoly on the invention (for example, a medicine) and can charge the highest price the market will bear.

Patent holder

The entity that holds the patent rights (e.g. an individual, pharmaceutical company, university, or public research institution).

Royalty

A royalty is a compensation paid to a patent holder in exchange for use of the patented invention.

Second-line ART

A second-line ART is needed for patients who have developed drug resistance to their initial regimen – their first-line ART. Second-line ART contains pills that are more expensive than first-line ART, and the regimen typically contains two to three tablets.

TRIPS Agreement

The 1994 World Trade Organization (WTO) Agreement on Trade-Related Aspects of Intellectual Property Rights (TRIPS) sets minimum standards for the protection of intellectual property, such as patents, in all WTO members (164 countries, as of July 2016). All members of the WTO must comply with the standards set by the TRIPS Agreement.

TRIPS Flexibilities

As expressly recognised in the Doha Declaration, the TRIPS Agreement contains several flexibilities that countries may use in order to, among other things, safeguard public health.

Unitaid

Unitaid founded the Medicines Patent Pool in 2010, and serves as its sole funder for HIV, hepatitis C and tuberculosis activities. An innovative financing mechanism, Unitaid is engaged in finding new ways to prevent, treat and diagnose HIV/AIDS, tuberculosis and malaria more quickly, more affordably and more effectively. It takes game-changing ideas and turns them into practical solutions that can help accelerate the end of the three diseases. We serve as an important implementer of Unitaid’s objectives through our engagement with a range of organisations to license key medicines for generic manufacture. Since 2010, Unitaid’s investments in the MPP have yielded 10.9 times the value of its funding through price reductions of generic products. Savings are projected to reach 2.3 billion by 2028 for HIV medicines alone.