Access to Medicine Index

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The Access to Medicine Index is an independent initiative that ranks the world’s 20 largest research-based pharmaceutical companies according to their efforts to improve access to medicine in 106 low- to middle-income countries.[1] The Index assesses how companies are making their products more available, affordable, accessible and acceptable to patients in need. By comparing companies to one another, the Index aims to stimulate pharmaceutical companies to play a bigger part in addressing the challenges of access to medicine in developing countries and to offer them insight into the activities of their peers.[2] Furthermore, the Access to Medicine Index seeks to create a platform for stakeholders from the pharmaceutical industry, governments, investors, civil society, patient organisations and academia to gather and form a common view of how these pharmaceutical companies can make further progress.

The Access to Medicine Index is published every two years by the Access to Medicine Foundation, an international not-for-profit organisation dedicated to improving access to medicine for people in need. The organisation is based in Haarlem, The Netherlands and receives financial support from donors such as the Bill & Melinda Gates Foundation, the UK Department for International Development]] (DFID) and the Dutch Ministry of Foreign Affairs.[3]

The most recent Access to Medicine Index, published in November 2014, ranks the top 20 pharmaceutical companies as follows:[4]

Company name (2014 score) 2014 Ranking 2012 Ranking
GlaxoSmithKline plc (3.3) 1 1
Novo Nordisk A/S (3.0) 2 6
Johnson & Johnson (2.8) 3 2
Novartis AG (2.8) 4 7
Gilead Sciences (2.8) 5 5
Merck KGaA (2.8) 6 8
Merck & Co. Inc. (2.6) 7 4
Sanofi (2.6) 8 3
AbbVie Inc (2.6) 9 n/a
Bayer AG (2.5) 10 9
Eisai Co. Ltd. (2.5) 11 15
Roche Holding AG (2.3) 12 10
Bristol-Myers Squibb Co. (2.2) 13 12
Boehringer Ingelheim GmbH (2.1) 14 17
AstraZeneca plc (1.9) 15 16
Pfizer Inc. (1.9) 16 11
Eli Lilly & Co. (1.7) 17 14
Astellas Pharma Inc. (1.6) 18 20
Daiichi Sankyo Co. Ltd. (1.5) 19 19
Takeda Pharmaceutical Co. Ltd. (1.5) 20 18

History[edit]

The Access to Medicine Index was developed starting in 2004 on the initiative of Dutch entrepreneur Wim Leereveld.[5] After years of working with the pharmaceutical industry, he concluded that simply "naming and shaming" the industry did not do enough to encourage big pharma to play their part in improving access to medicine in the developing world. Leereveld noticed that there were many different (and sometimes conflicting) opinions about what the pharmaceutical industry should be doing with regard to access to medicine, but that there was no tool to recognise good practice within the pharmaceutical industry and no framework for collective dialogue surrounding this issue. He set out to develop a ranking system that would show which pharmaceutical companies do the most to improve access to medicine and how, and also help stakeholders to collectively define companies’ role in increasing access to medicine.[5]

The first Access to Medicine Index was published in 2008, followed by a new Index every two years.

Methodology[edit]

The Access to Medicine Index uses a weighted analytical framework to capture and compare company data.[6] The framework is constructed along seven areas of focus called ‘Technical Areas’, which cover the range of company business activities considered relevant to access to medicine. Within each area, the Index assesses four aspects of company action called ‘Strategic Pillars’: commitment, transparency, performance and innovation.[7] [8] [9]

Access to Medicine Index Methodology Framework

Technical Areas[6][7][8][9]

General Access to Medicine Management: This Technical Area strives to capture each company's overall approach to the management of access to medicine. Under this Technical Area, the Index measures how access to medicine is represented at senior management levels in the company, how incentive and performance management structures are used to drive good access-related performance and the company's approach to setting and monitoring targets for access initiatives. Finally, this Technical Area examines the company's level of engagement with different stakeholders in relation to improving access to medicine in Index Countries.

Public Policy & Market Influence: This Technical Area looks at each company’s overall management of external relationships - with policy makers, competitors, users and/or customers - that impact access. It includes sub-areas of lobbying and advocacy practices (including anti-bribery and anti-corruption), competition policies and practices, and marketing policies and practices. It seeks to capture the influence of the company and its impact on access to medicine in the Index Countries.

Research & Development: This Technical Area concentrates on company efforts (both in-house and through collaboration) to develop new or adapted remedies for high priority diseases in the Index Countries where there is a research need and a market failure. It also captures any controversies related to clinical trials and the company's approach to monitoring ethical standards. The impact of intellectual capital sharing and licencing details pertaining to collaborative research and development is also highlighted.

Pricing, Manufacturing & Distribution: This Technical Area addresses how each company’s pricing policies and approach to supply chain and packaging issues impact access to medicine in Index Countries. The main topics under this area are the company’s approaches to equitable pricing (e.g. through tiered pricing schemes). It also investigates a company's criteria for applying for market approval or WHO pre-qualification in Index Countries, its methods of quality assurance for product delivery, and its approaches to distribution and packaging in Index Countries.

Patents & Licensing: This Technical Area analyzes each company's intellectual property protection policies and practices in the Index Countries with regard to their impact on access to medicine. Major topics covered under this area are the company's approach to TRIPS, TRIPS flexibilities and additional bilateral/multilateral agreements beyond TRIPS (sometimes referred to as TRIPS+), including patent filing, in Index Countries. It also covers each company's socially responsible and humanitarian use licencing practices, the use of non-exclusive voluntary licences or non-assert declarations for Index Disease products in Index countries, and their stance towards patent pools and intellectual property sharing.

Capability Advancement: This Technical Area examines company initiatives conducive to building Index Country capacity in product development, distribution and research and development, as well as activities related to national pharmacovigilance programmes. Initiatives in this area can include collaborations with Index Country organisations, development of quality management capacities, technology transfer to local manufacturers or local in-house facilities, and contribution to the establishment of pharmacovigilance systems in the Index Countries. Initiatives to build other capacities outside the pharmaceutical value chain may be captured as long as no conflict of interest is detected.

Methodology development [6][7][8][9]

The Access to Medicine Index methodology is developed in consultation with many individuals and organisations around the world. The stakeholder consultation and review process occurs every two years, starting in the year prior to the publication of an Index. This process is meant to keep the Access to Medicine Index responsive to the changing global health environment, based on expertise from a broad range of relevant perspectives, and to enable refinement of the framework through which companies are assessed. The consultation process is characterized by three phases: firstly, stakeholder views about the Index are gathered with the help of a public online questionnaire. Secondly, a number of roundtable meetings are held for a face-to-face consultation with stakeholder representatives. Finally the feedback is consolidated and synthesised with the support of the Expert Review Committee and Technical Subcommittees. The details of the process vary depending on the evolving needs of the initiative.

The Expert Review Committee (ERC) is made up of individuals from a variety of stakeholder groups all active in some capacity on the access to medicine agenda. The mandate of the ERC is advisory in nature with the objective of providing guidance, recommendations and advice to the Access to Medicine Index team on the scope, structure, content and methodology of the Access to Medicine Index assessment. The diverse composition of the ERC is meant to ensure different viewpoints and perspectives are taken into consideration when establishing the latest Access to Medicine Index Methodology.

Data collection[6][7][8][9]

Once the methodology has been agreed upon, an external research party collaborates with the Access to Medicine Foundation to collect and analyze company data. Data for the Access to Medicine Index comes from a variety of sources, including publicly available material, information provided by companies via an online platform and information sent from other bodies to those developing the Index upon request.

Scoring[10]

In accordance with the Access to Medicine Index methodology framework, companies rated by the Index receive a separate score for each Technical Area. These scores are composed of multiple indicator scores that measure a company’s commitment, transparency, performance and innovation within each Technical Area. A company’s overall score, which determines its overall Index rank, is a weighted combination of its scores in each Technical Area. Company scores are calculated on a relative scale of 0 to 5, with 0 indicating the lowest score among the company set and 5 signifying the highest score among the company set.

Scope[edit]

Company Scope[6][7][8][9]

The Access to Medicine Index ranks the top 20 originator (research-based) pharmaceutical companies, based on market capitalisation and the relevance of their product portfolios to diseases in the developing world. One unlisted company, Boehringer Ingelheim, is also included since it meets the size and portfolio relevance criteria.

In 2008 and 2010, the Access to Medicine Index also measured companies engaged exclusively in the production of generic medicines. Based on feedback from the 2011 stakeholder consultations, these companies were excluded from the 2012 and 2014 iterations. Changes within the pharmaceutical industry, such as mergers and acquisitions, also influenced changes in the company scope between 2008 and 2014.

Geographic scope[6][7][8][9]

The Access to Medicine Index focuses on developing and less developed countries, based on World Bank[11] and United Nations[12] classifications measuring economic advancement and human development. The 2014 Index measured developments in a total of 106 countries.

The 2014 Index includes countries that are considered to be low income and lower-middle income countries by the World Bank. In addition, countries that are classified as low human development countries and medium human development countries by the UN Human Development Index are also included. Based on the UN Inequality-Adjusted Human Development Index the Index added four high human development countries to the 2014 Index based on socio-economic inequality.

Disease scope[6][7][8][9]

The Access to Medicine Index covers a range of diseases based on their aggregate global disease burden and their relevance to pharmaceutical interventions, in accordance with non-age-weighted WHO Disability Adjusted Life Years (DALY)[13] data. Those diseases for which pharmaceutical interventions were irrelevant (such as violent death, trauma and snakebites) are excluded. In 2014, the disease scope consisted of a combination of the following:

  • The top 10 communicable diseases based on Disability Adjusted Life Years (DALY) from the WHO Global Burden of Disease: 2004 update [14]
  • The top 12 non-communicable diseases based on DALYs from the WHO Global Burden of Disease: 2004 update [14]
  • 17 of the WHO Neglected Tropical Diseases[15]
  • 8 maternal and neonatal health conditions based on the WHO Global Burden of Disease: 2004 update.[14] In addition, the Index captures activity on contraceptives

Product type scope[6][7][8][9]

To reflect the range of available product types for prevention, diagnosis and treatment of diseases, the Index maintains a broad product type scope which draws closely from definitions provided by the G-Finder Summary of R&D.[16]

Index coverage and use[edit]

Since its inception, the Access to Medicine Index has progressed to be a frequently cited and ‘authoritative’ benchmark for pharmaceutical companies with regard to their access to medicine initiatives. In addition to global media outlets reporting on the Access to Medicine Index and its findings, significant coverage includes:

  • In July 2008, Bill Gates mentioned the Access to Medicine Index in an interview with Time Magazine as an example of an incentive that works to give businesses credit for what they are already doing to address the challenges of access to medicine in developing countries.[17]
  • Paul Hunt, the former UN Special Rapporteur, describes the Index as a way to measure the pharmaceutical industry's progress in line with human rights obligations in a 2010 PLOS Medicine report.[18]
  • The Index was also cited in a 2010 UBS report as a tool for investors to assess access to medicine specifically and, where necessary, separately from corporate social responsibility (CSR) frameworks.[19]
  • Since 2008, the Access to Medicine has been repeatedly cited in such scientific journals as the British Medical Journal[20] and The Lancet.[21][22]

Criticism[edit]

The results of the Access to Medicine Index are based on company data provided by the pharmaceutical companies themselves. Self-reported data does carry with it an inherent risk, but the Access to Medicine Index also uses dependable external sources to verify data provided by the companies wherever possible. Additionally, it is in companies’ best interest to be as forthcoming as possible, as they are a. rated by the Index on their degree of transparency and b. rated on their performance every 2 years, so that failures to meet their commitments and/or inconsistencies over time are likely to be uncovered.

References[edit]

  1. ^ World Health Organization. "Access to Medicine Index, 2012". WHO Medicines Documentation. World Health Organization. Retrieved 11 March 2013. 
  2. ^ "What is the Index?". 
  3. ^ UK Department for International Development. "The Access to Medicine Index: Encouraging global access to health care". DFID News. DFID. Retrieved 11 March 2013. 
  4. ^ "Pharmaceutical industry doing more to improve access to medicine in developing countries; performance on some aspects lags". 
  5. ^ a b Levy, Gideon. "Patents or Patients". AVRO. Retrieved 11 March 2013. 
  6. ^ a b c d e f g h "Access to Medicine Index Methodology". Access to Medicine Foundation. Retrieved 13 June 2013. 
  7. ^ a b c d e f g h "2012 Methodology Report- Stakeholder Review". Access to Medicine Foundation. Retrieved 13 June 2013. 
  8. ^ a b c d e f g h "2010 Methodology Report- Stakeholder Review". Access to Medicine Foundation. Retrieved 13 June 2013. 
  9. ^ a b c d e f g h "2008 Methodology Report- Stakeholder Review". Access to Medicine Foundation. Retrieved 13 June 2013. 
  10. ^ "Ranking & Scoring Process". Access to Medicine Foundation. Retrieved 13 June 2013. 
  11. ^ "How we classify countries". World Bank. Retrieved 11 March 2013. 
  12. ^ "Least Developed Countries: UN Classification". The World Bank. Retrieved 11 March 2013. 
  13. ^ "Health statistics and health information systems: DALY". World Health Organization. Retrieved 11 March 2013. 
  14. ^ a b c "The Global Burden of Disease (GBD) 2004 update". World Health Organization. Retrieved 18 November 2014. 
  15. ^ "The 17 neglected tropical diseases". World Health Organization. Retrieved 18 November 2014. 
  16. ^ "Global Funding of Innovation for Neglected Diseases: G-FINDER". Policy Cures. Retrieved 11 March 2013. 
  17. ^ Gates & Kiviat, Bill, Barbara (31 July 2008). "Making Capitalism More Creative". Time Magazine. Retrieved 11 March 2013. 
  18. ^ Hunt & Khosla, Paul, Rajat. "Are Drug Companies Living Up to Their Human Rights Responsibilities? The Perspective of the Former United Nations Special Rapporteur (2002-2008)". PLOS Medicine. Retrieved 11 March 2013. 
  19. ^ "Global Pharma: Doing well by doing good?". UBS Investment Research. Retrieved 18 June 2013. 
  20. ^ Yudkin, John S. "Post-marketing observational trials and catastrophic health expenditure". British Medical Journal. Retrieved 11 March 2013. 
  21. ^ Ali & Narayan, Mohammed K., KM Venkat. "The New Access to Medicine Index". The Lancet. Retrieved 11 March 2013. 
  22. ^ Newsdesk (August 2010). "Bridging the gap in access to medicines". The Lancet 10: 514–515. doi:10.1016/s1473-3099(10)70150-x. Retrieved 11 March 2013. 

External links[edit]