Glossary of terms

The term given to the practice / research area for accessibility of medical products to relevant stakeholders.

Acronym for key Emerging Markets: Brazil, Russia, India and China

These may be initiated as an alternative to patient assistance programmes to allow limited access to a new product if a company does not wish to provide transparent access to reduced price or free drugs.

Sanctioning patent rights to be revoked by companies other than the originator of a therapeutic agent / diagnostic.

Refers to corporate self-regulation that is integrated into a business model. Essentially, CSR is the deliberate inclusion of public interest into corporate decision-making, and the honoring of a triple bottom line: People, Planet and Profit. In a healthcare specific context, it includes the degree with which companies adopt a patient-centric approach and the extent to which they address accessibility issues.

see Ministry of Health

A term used to define less developed economies. There are a range of determining factors that may vary across emerging markets including GDP per capita (as benchmarked by the World Bank), human development (HDI) and level of healthcare. Emerging markets are attractive due to the potentially high growth rates resulting from economic reform. For the purpose of this website, we have defined Emerging Markets using data provided by the Financial Times (and London) Stock Exchange (FTSE) and Morgan Stanley Capital International (MSCI).

Any programme designed to improve access to patients, often achieved through expanded clinical trials or compassionate-use programmes.

Index used to rank countries by level of “human development” which usually also implies whether a country is developed, developing or underdeveloped.

Refers to various country-specific constraints to accessing healthcare treatment and services and includes urban / rural population distribution; healthcare system and diagnostic / treatment capacity and patient affordability.

This relates to the patented life of a drug, in various forms, eg product, process (manufacturing) patents. In the context of "access", IP is often challenged, especially in relation to high-priced products which address high unmet medical need. Compulsory Licensing can occur whereby the patent rights are not upheld in a country and generic manufacturers have freedom to enter the market.

These are experts who influence their peers' medical practice including, but not limited to, prescribing behaviour. Pharmaceutical companies generally engage KOLs early in the drug development process to provide advocacy activity and key medical / marketing feedback. KOLs are commonly aligned to a specific area of expertise, such as oncology, cardiology, diabetes or infection. Some KOLs can act as advisors to Regulatory Authorities such as the Food & Drug Administration (FDA) or European Medicines Agency (EMEA). KOLs are frequently engaged in conducting clinical trials, publications, marketing research and advisory boards.

The name given to a country which, according to the United Nations, exhibits the lowest indicators of socioeconomic development, holding the lowest HDI rankings of all countries in the world. A country is classified as an LDC if it meets three key criteria based on:

• Low income
• Human resource weakness and
• Economic vulnerability.

Once a product is licensed, market access refers to a company’s ability to secure funding in alignment with the commercial strategy. This requires third-party funding for the target positioning and indications. Funding can be achieved through reimbursement (after approval), either public or private, and / or through patient out-of-pocket expenditure.

Most executive governments in the world are divided into ministries or departments. In most such cases, there is a ministry responsible for health. An MoH focuses on issues related to the general health of the citizenry.

This is a term that has become widely accepted as referring to a legally constituted, non-governmental organisation created by natural or legal persons with no participation or representation of any government. In the cases in which NGOs are funded totally or partially by governments, the NGO maintains its non-governmental status and excludes government representatives from membership in the organisation.

This is the ability of a patient to gain equitable, reliable, safe, affordable and sustainable access to a medicine, treatment and / or service that he or she needs. Barriers to patient access can be due to costs / affordability, awareness, education and deficiencies in healthcare systems. At Health Access Strategies, our access approach prioritises patient access as a key success factor to any access strategy.

These programmes include:

• Charitable donations or fully subsidised improved access schemes
• Patient co-payment assistance schemes
• Variable pricing strategies

Among the leading 20 markets from 2008 forward, these countries have a higher Compound Annual Growth Rate (CAGR) 2007-2012, a transitional disease profile, growing access to medicines and expanding public health programmes.

The phase following regulatory approval for a therapeutic agent / diagnostic.

The phase prior to regulatory approval for a therapeutic agent / diagnostic.

Refers to the long-term equilibrium exchange rate of two currencies to equalise their purchasing power. It is based on the law of one price: the theory states that, in ideally efficient markets, identical goods should have only one price. The theory can be useful in determining levels of affordability within given markets.

The activities undertaken to identify and develop new medical treatments. The trials conducted are normally classified as phase I, II, III and IV.

Stakeholders comprise of any group or individual with a vested interest in the objectives, purpose and outcomes of a project, including KOLs, Governments, patients and advocacy groups, etc.

Any entity which acts as an independent broker / facilitator between key stakeholders (eg pharma company and doctors / patients).

Made up of the International Bank for Reconstruction and Development (IBRD) and the International Development Association (IDA). Activities are focused on developing countries and they provide loans at preferential rates to member countries as well as grants to poorest countries. Along with the World Health Organisation, the World Bank is a significant stakeholder in the global access arena.

Specialized agency of the United Nations (UN) that acts as a coordinating authority on international public health. Along with the World Bank, WHO is a significant stakeholder in the global access arena and is responsible for providing leadership on global health matters, shaping the health research agenda, setting norms and standards, articulating evidence-based policy options, providing technical support to countries and monitoring and assessing health trends.