Methodology Index 2010

• General Access to Medicine Management

  10 %

• Public Policy & Market Influence

  10 %

• Research & Development

  25 %

• Equitable Pricing, Manufacturing & Distribution

  20 %

• Patents & Licensing

  15 %

• Capability Advancement in Product Development & Distribution

  10 %

• Product Donations & Philanthropic Activities

  10 %

Commitments

• Governance System

  11 %
  The company has a governance system that includes direct board-level responsibility and accountability for its access to medicine initiatives for the Index Countries.

• Public Policy

  11 %
  The company has a public policy in place in-which it explains the rationale for its access to medicine activities in the Index Countries and the overall firm objectives in this area.

• Collaboration

  9 %
  The company commits to work with the stakeholders including universities, patient groups, local governments, employees, local and international NGOs and peers with the aim of improving access to medicines in the Index Countries for the Index Diseases.

Transparency

• ATM Annual Report

  11 %
  The company publishes a publicly available annual report on its access to medicine policies and practices

• Resource Disclosure

  9 %
  The company publicly discloses information on a regular basis, regarding the overall resources dedicated to improving access to products for Index Diseases in the Index Countries.

• Performance Disclosure

  11 %
  The company publicly discloses quantitative and qualitative performance measures and targets for its access to medicine practices related to the Index Countries.

Performance

• FTE Dedication

  3 %
  Total full-time employees dedicated to access to medicine initiatives related to the Index Diseases and Index Countries across the company.
  Data available to score this performance indicator was not comparable and reliable for several companies. Consequently, this performance indicator was exceptionally scored based on the average of commitments and transparency scores of the companies in this area.

• Management System

  12 %
  The company has a management system including quantitative targets to implement and monitor its Access to Medicine strategy in the Index Countries.

• Public Debate

  9 %
  The company participates in public debate and engages with the different stakeholder groups with the goal of dialog and knowledge sharing aimed at improved access to products for the Index Diseases in the Index Countries (measured through sponsoring and participating in relevant conferences, workshops etc.).

• ATM Revenues

  6 %
  Trends in the company's revenue from sales in the emerging markets compared to revenues from sales in the rest of the world during the past five years.
  Data available to score this performance indicator was not comparable and reliable for several companies. Consequently, this performance indicator was exceptionally scored based on the average of commitments and transparency scores of the companies in this area.

Innovation

• ATM Management

  10 %
  The company has adopted innovative (unique in the sector) approaches to General Access to Medicine Management including ATM governance, ATM Management System and stakeholder engagement.

Commitments

• Lobbying Transparency

  9 %
  The company commits to transparency in its lobbying activities and the positions it seeks to promote where it has an impact on access to medicine in the Index Countries.

• Competition Behaviour

  9 %
  The company commits to endorse and support competition and to refrain from anti-competitive practices in the pharmaceutical markets in the Index Countries for products related to the Index Diseases.

• Data Exclusivity

  6 %
  The company refrains from pursuing data exclusivity for products related to the Index Diseases in the Index Countries.

• Ethical Marketing

  3 %
  The company commits to internal or external ethical codes for marketing of pharmaceutical products (WHO Ethical Criteria for Medicinal Drug Promotion or the International Federation of Pharmaceutical Manufacturers & Associations (IFPMA) Code of Marketing Practices).

• Distributors Marketing

  3 %
  The company commits to demand ethical marketing practices from its local third party distributors consistent with its own internal standards.

Transparency

• Advocacy

  5 %
  The company publicly discloses the positions it seeks through its advocacy activities related to access to medicines in the Index Countries (direct advocacy).

• Support Disclosure

  5 %
  The company annually and publicly discloses which individuals, patient associations, political parties, trade associations, and academic departments it financially supports, through-which it might advocate its public policy positions at regional, national or international levels where relevant to access to medicine in the Index Countries.

• Board Disclosure

  3 %
  The company publicly discloses its board seats at industry associations and advisory bodies related to health access issues for the Index Diseases and the Index Countries.

• Policy Disclosure

  9 %
  The company publicly discloses its policies related to competition in areas such as data exclusivity, patent extensions etc. in the Index Countries.

• Promotional Disclosure

  6 %
  The company publicly discloses detailed information regarding its marketing and promotional programs in the Index Countries, such as payments to physicians or other key opinion leaders and also its promotional activities for other healthcare providers, distributors etc.

• Litigation Disclosure

  3 %
  The company publicly discloses information regarding its breaches of codes (such as the IFPMA Ethical Marketing Guidelines) and also litigations related to marketing practices in the Index Countries.

Performance

• Controversy Disclosure

  9 %
  Has the company been involved in any controversial cases of lobbying activities in the Index Countries? Such cases include illegal payments to local governments or other forms of illegal influence which have resulted in fines or legal proceedings during the past five years.

• Competition Behaviour

  9 %
  Is there material proof of the company's anti-competitive behavior in the Index Countries based on fines or litigation records during the past five years?

• Ethical Marketing

  6 %
  Have there been breaches of The International Federation of Pharmaceutical Manufacturers & Associations (IFPMA) Code of Pharmaceutical Marketing Practices or litigations or fines levied against the company related to marketing behavior in the Index Countries during the past five years?

• Distributors Marketing

  3 %
  Does the company include ethical marketing requirements consistent with international codes and standards (such as the IFPMA Code of Pharmaceutical Marketing Practices) in its agreements with its Index Country distributors?

• Code of Conduct

  3 %
  Does the company have an employee code of conduct in place for the Index Countries, which emphasizes ethical marketing principles equivalent to the company's codes in this area for the Western markets?

Innovation

• Competition Behaviour

  10 %
  The company has adopted an innovative (unique in the sector), sustainable approach to improving the level of competition for Index Disease Products in the Index Countries.

Commitments

• R&D

  9 %
  The company commits to carry out research focusing on the development of new remedies for the Index Diseases with the goal of improving access to medicine in the Index Countries through in-house R&D and/or research collaborations. (Innovative Research)

• New Formulations

  9 %
  The company commits to carry out research and development aimed at developing new formulations (such as fixed dose combinations, pediatric formulations, heat-resistant preparations etc.) of the existing products for the Index Diseases suitable to the Index Countries. (Adaptive Research)

• Clinical Trial Codes

  2 %
  The company commits to make available for free the products in the countries where the clinical trials for those products were carried out, consistent with codes such as the Helsinki Code for Clinical Trials.

• IP & Patents

  8 %
  The company commits to share its intellectual property (patents, molecules library) with the institutions carrying out research and development for the Index Diseases aimed at improved access to medicine in the Index Countries.

• Intellectual Capital

  3 %
  The company commits to waive its rights in the Index Countries to the intellectual capital generated in public private partnerships for the Index Diseases.

Transparency

• R&D Investment

  9 %
  The company discloses the resources dedicated to its research and development activities related to the Index Diseases suitable the Index Countries (exclusions apply - for details please refer to the Access to Medicine Index 2010 Methodology Document).

• Terms & Conditions

  9 %
  The company discloses the terms and conditions for its research collaborations related to the Index Diseases (with regard to Intellectual Property rights, duration etc.).

• Collaboration Investment

  6 %
  The company discloses the resources dedicated to its research collaborations related to the Index Diseases (both human resources and financial).

• Research Pipeline

  3 %
  The company publicly discloses its research pipeline related to both in-house research and collaborations targeting Index Diseases (where disclosure is not legally required).

• Clinical Trial

  3 %
  The company discloses information about the result of its clinical trials in the Index Countries and its approach to providing access to the products in the countries where the products are tested (when it is beyond legal requirements).

Performance

• Relative R&D

  3 %
  Portion of financial R&D investments dedicated to Index Diseases (exclusions apply - for details please refer to the Access to Medicine Index 2010 Methodology Document) out of the company's total R&D expenditures.

• New Molecules

  6 %
  Share of research pipeline reflecting 'new molecules’ for Index Diseases (exclusions apply - for details please refer to the Access to Medicine Index 2010 Methodology Document) including in-house and collaborative research.

• Adapted Molecules

  6 %
  Share of research pipeline reflecting ‘adapted molecules or new technologies’ specific to an Index Disease and an unmet need in an Index Country, including in-house and collaborative research (e.g. pediatric formulations, Fixed Dose Combinations, delivery technologies suitable to Index Diseases, heat resistant preparations etc.)

• Research Collaboration

  5 %
  Research collaborations in which the company has been involved, with the aim of developing products or new formulations for Index Diseases specifically targeting Index Countries' needs (adjusted for the number of the molecules in the company's research pipeline).

• Publications

  2 %
  Peer-reviewed research papers published as a result of the research collaborations of the company with public-private partnerships or universities relevant to the Index Diseases (R&D exclusions apply - for details please refer to the Access to Medicine Index 2010 Methodology Document).

• Terms & Conditions

  2 %
  The company provides proof that the terms and conditions of its research collaborations are conducive to improving access to Index Disease products access the Index Countries for the individuals with significant financial barriers to access.

• Clinical Trial

  2 %
  Has the company been the subject of any breach of international codes or lawsuits related to its clinical trial practices in the Index Countries during the last five years?

• Intellectual Capital

  6 %
  The company provided proof of sharing its intellectual capital (includes molecules library, patented compounds, processes or technologies) on terms most conducive to access, with research institutions which develop products for Index Diseases targeted at the Index Countries.

Innovation

• R&D Business Model

  5 %
  The company has adopted innovative (unique in the sector), sustainable business models for research into Index Diseases (excluding new molecules for non-communicable Infectious Diseases).

• IP & Patents

  5 %
  The company has engaged in innovative (unique in the sector) sustainable models for sharing intellectual property and patent rights with the other entities, which may result in improved access to suitable products for Index Diseases in the Index Countries.

Commitments

• Inter-country Pricing

  6 %
  The company commits to implement inter-country tiered pricing models for the products related to the Index Diseases in the Index Countries targeting countries which experience the highest financial barriers to access.

• Intra-country Pricing

  3 %
  The company commits to implement intra-country tiered pricing models for the products related to the Index Diseases in the Index Countries targeting individuals who experience the highest financial barriers to access.

• Pricing Control

  5 %
  The company commits to make its best efforts to control the pricing practices of its local sales agents or to choose multiple sales agents/distributors for each market with the aim of improving affordability and accessibility of the products.

• Quality Standard

  5 %
  The company commits to maintain its drug quality standards in the Index Countries at least equal to FDA, EMA or WHO standards.

• Drug Recall

  2 %
  The company commits to create the processes and dedicate the resources needed to carry out effective drug recalls in the Index Countries where it operates.

• Packaging Adaptation

  3 %
  The company commits to adapt the brochure and packaging of its products to the local needs of the target communities in the Index Countries.

• Marketing Approval

  5 %
  The company commits to register (obtain marketing approval for) its products for the Index Diseases in the Index Countries in need.

• Distribution Effort

  3 %
  The company commits to make best efforts in the production and distribution of its products to prevent drug diversion in the Index Countries for the Index Diseases.

Transparency

• Pricing Approach

  6 %
  The company publicly discloses details of its equitable pricing approach for the Index Countries for products related to the Index Diseases.

• Pricing Outome

  9 %
  The company publicly discloses the outcome of its equitable pricing programs (based on indicators such as number of patients having received the product, number of doses delivered based on the equitable price etc.)

• Decision Process

  6 %
  The company publicly discloses its decision process regarding registration (marketing approval), and also the status of marketing approvals for each product related to Index Diseases in the Index Countries.

• Quality Management

  3 %
  The company discloses information about its quality management systems for products destined for the Index Countries (standards, processes, resources, etc.).

• Quality Issues

  3 %
  The company publicly discloses information about the drug recalls and breaches it has been involved in related to drug quality issues in the Index Countries.

• Sales Disclosure

  3 %
  The company discloses the breakdown of its sales revenues for each product relevant to Index Diseases at the country level for the Index Countries.

Performance

• Inter-country Pricing

  8 %
  The company has inter-country tiered pricing schemes for the Index Countries for the products for Index Diseases (to be analyzed across products portfolio including drugs, vaccines, diagnostic kits, vector controls, microbicides etc.), which aim at achieving affordable access to such products for the Index Countries.

• Intra-country Pricing

  6 %
  The company has intra-country tiered pricing schemes in the Index Countries for Index Disease products (to be analyzed across products portfolio including drugs, vaccines, diagnostic kits, vector controls, microbicides etc.)which aim at achieving affordable access to such products for those with the highest financial barriers to access.

• Marketing Approval

  8 %
  Has the company attempted to register (obtain marketing approval for) its products for Index Diseases in the Index Countries in need?

• Drug Recall

  3 %
  Have drug recalls occurred due to product or packaging quality issues in the Index Countries for products produced by the company or its voluntary licensees during the past five years?

• Prequalification

  3 %
  The company files for WHO Prequalification list or tentative approval of US Food and Drug Administration for its eligible products for the Index Diseases.

• Packaging Adaptation

  3 %
  Do all company products, destined for Index Countries, for which tiered pricing is used, have special packaging or other distinct markers to prevent product diversion?

Innovation

• Equitable Pricing

  5 %
  The company has introduced innovative approaches (unique in the sector) to equitable pricing which help with sustainable delivery of the products for Index Diseases to individuals in the Index Countries who face the highest financial barriers to access.

• Manufacturing & Distribution

  5 %
  The company has introduced innovative approaches (unique in the sector) to manufacturing and distribution of products for the Index Diseases which may help with sustainable delivery of such products for the Index Diseases in the Index Countries.

Commitments

• Patent Enforcement

  8 %
  The company commits to refrain from attempting to enforce its patents related to its products for the Index Diseases in the Least Developed Countries. (In this exceptional case instead of the UN HDI Low Human Development Countries (LHDCs), we refer to UN Least Developed Countries (LDCs) to maintain consistency with the demands of the Doha Declaration on TRIPS Agreement and Public Health.)

• TRIPS

  8 %
  The company commits to respect the right of the Index Countries to use the TRIPS flexibilities in-line with the Doha Declaration on the TRIPS Agreement and Public Health in the Index Countries.

• Non-exclusive Licensing

  11 %
  The company commits to engage in non-exclusive licensing for the Index Disease products to generic manufacturers with the aim of increased accessibility and affordability. [consider non-exclusive voluntary licenses equivalent to non-assert declarations]

• Voluntary Licensing

  5 %
  The company commits to charge license fees from its voluntary licensees which are conducive to manufacturing of affordable Index Disease products for sale in Index Countries.

Transparency

• TRIPS

  14 %
  The company publicly discloses its stance with regard to patent related issues in the Index Countries such as TRIPS, usage of TRIPS flexibilities based on the Doha Declaration on TRIPS, patent extensions, etc. for products related to the Index Diseases in the Index Countries.

• Patent Disclosure

  8 %
  The company discloses the patent status of its products for the Index Diseases in the Index Countries.

• Voluntary Licensing

  9 %
  The company publicly discloses detailed information about the voluntary licensing activities it is engaged in for products related to the Index Diseases for the Index Countries. (Such as license duration, license territory, technology transfer etc.) [non-assert declarations considered equivalent to voluntary licenses]

Performance

• Patent Enforcement

  12 %
  Is there proof of the company's patenting practices which result in decreased affordability or accessibility of products for Index Diseases in the Index Countries? Such practices include patenting in Least Developed Countries, and acting against usage of TRIPS flexibilities by the Index Countries based on the Doha Declaration on TRIPS.

• Non-exclusive Licensing

  12 %
  Does the company actively engage in non-exclusive voluntary licensing for the Index Countries for its products related to the Index Diseases? [Multiple 'active' voluntary licenses should be in place for the drug to be counted without global or regional marketing exclusivity for the licensee. An active license is a license under which production is happening or the licensee is actively progressing towards production.]

• Technology Transfer

  3 %
  Does the company have effective technology transfer regimes in place to improve the quality and production capacity of its voluntary licensees?

• Patent Pools

  3 %
  The company supports patent pools such as UNITAID both for centralized procurement and for development of new remedies for the Index Diseases in the Index Countries.

Innovation

• Voluntary Licensing

  5 %
  The company has adopted innovative (unique in the sector) initiatives aiming at increased effectiveness of its voluntary licensing programs.

• Patent Enforcement

  5 %
  The company has engaged in innovative (unique in the sector), sustainable programs with the aim of decreasing the impact of patent enforcement on the affordability and accessibility of medicine to the individuals with financial barriers to access.

Commitments

• Quality Management

  9 %
  The company commits to assist its Index Country licensees and contract manufacturers with their quality management systems aimed at achieving international standards such as the FDA, EMA, WHO Good Manufacturing Practices, etc.

• Public Private Partnerships

  9 %
  The company commits to engage in research focused public-private partnerships with Index Country organizations and to support research at the Index Country academic institutions with the aim of increasing local capabilities in this area.

• Supply Chain

  9 %
  The company commits to help the Index Country governments and distributors in improving their pharmaceutical supply chain capabilities with the aim of improving affordability, accessibility and quality of the delivered Index Disease Products. Examples include providing help in establishing cold chains and in introducing processes or technologies which can help prevent drug diversion or counterfeiting in the Index Countries.

• Pharmacovigilence

  3 %
  The company commits to support the implementation of pharmacovigilance systems in the Index Countries.

Transparency

• Control Mechanism

  12 %
  The company provides information about the mechanisms it applies to ensure that Index Country licensees and contract manufacturers maintain high quality of production consistent with international standards such as the FDA, EMA and/or WHO Good Manufacturing Practices etc.

• Collaboration Disclosure

  14 %
  The company provides information about its collaborations with Index Country organizations with the aim of creating local research capacity for the Index Diseases.

• Pharmacovigilence

  5 %
  The company discloses details regarding its activities related to establishing pharmacovigilance systems in the Index Countries.

Performance

• Quality Management

  9 %
  Is there evidence that the company assists local licensees or contract manufacturers to achieve international drug manufacturing standards (such as FDA, EMA or the WHO Good Manufacturing Practices) in the Index Countries?

• Local Capacity

  9 %
  Is there evidence that the company participates in public-private partnerships in the Index Countries with the aim of increasing local capacity for research? Does the company support the research carried out by Index Countries' academic institutions?

• Supply Chain

  9 %
  The company is engaged in programs and partnerships aimed at improving pharmaceutical supply chain capacity in the Index Countries with the aim of improved affordability, accessibility and quality of the delivered Index Disease Products. Examples include providing help in establishing cold chains and in introducing processes or technologies which can help prevent drug diversion or counterfeiting in the Index Countries.

• Pharmacovigilence

  3 %
  The company actively engages in establishing and supporting pharmacovigilance-related programs in the Index Countries during the analysis period.

Innovation

• Quality Management

  5 %
  The company has introduced innovative (unique in the sector) approaches to working with the Index Country organizations to improve the quality and accessibility of the products for Index Diseases, in areas such as countering drug diversion, counterfeiting, and local quality management.

• Local Capacity

  5 %
  The company has introduced innovative (unique in the sector) approaches to working with the Index Country organizations which help improve the local research capacity for the Index Diseases.

Commitments

• WHO Donation Compliance

  6 %
  The company commits to comply with the World Health Organization Inter-Agency Guidelines for Drug Donations in the Index Countries for all its drug donation activities.

• Patient Reach

  12 %
  The company commits to make its best efforts to assure the donated products are administered to patients in the target Index Country.

• Health Infrastructure

  12 %
  The company commits to invest in health infrastructure-related philanthropic projects in the Index Countries with the aim of sustainable and efficacious pharmaceutical supply systems.

Transparency

• Donation Process

  9 %
  The company publicly discloses the process for deciding the drug types and destinations for its donations programs in the Index Countries.

• Donation Scale

  9 %
  The company publicly discloses detailed information about the type, volume and destination of the donated products in the Index Countries.

• Philanthropy Rationale

  6 %
  The company publicly discloses the rationale behind its philanthropic activities and their relevance to long-term sustainable access to medicines in the Index Countries.

• Philantropy Investment

  6 %
  The company publicly discloses the output and the amount of resources dedicated to its philanthropic activities in the Index Countries.

Performance

• WHO Donation Compliance

  6 %
  Has the company been fined or been proven to have breached the WHO Guidelines for Drug Donations during the last five years?

• Donation Termination

  3 %
  Has the company prematurely terminated any of its donations programs in the Index Countries during the last five years?

• Donation Scale

  9 %
  The scale and scope of donated products to the Index Countries during the period of analysis.

• Philantropy Investment

  12 %
  Value of the company's philanthropic activities (excluding drug donations) in the Index Countries during the period of analysis adjusted for company size?
  Data available to score this performance indicator was not comparable and reliable for several companies. Consequently, this performance indicator was exceptionally scored based on the average of commitments and transparency scores of the companies in this area.

Innovation

• Sustainable Donation

  6 %
  The company has introduced innovative (unique in the sector), sustainable approaches to managing drug donations which may result in increased effectiveness and efficacy.

• Sustainable Philantropy

  4 %
  The company has introduced innovative (unique in the sector) approaches to philanthropic programs in the Index Countries which may result in sustainable health improvements.