Roche Holding AG

Stock Exchange: XSWX • Ticker: ROG • HQ: Basel, Switzerland • Employees: 91,747

Ranking by technical area
Ranking by strategic pillar

Performance

Roche falls seven places. It has advanced in compliance, with enforcement processes that also apply to third parties. It lags in R&D, as its commitments are not linked to need within the scope of the Index, it does not share intellectual property for R&D with relevant stakeholders and has no policy of basing R&D partnerships on pro-access terms. It applies equitable pricing strategies to only a limited portion of its products. In IP-management, Roche commits to not filing for or enforcing patents in low- or middle-income countries, and has enabled technology transfer for HIV/AIDS treatments. Roche donates products for diabetes and commits to building capacity in several areas.

In comparison with other companies, Roche’s public transparency, and therefore its commitment to accountability and knowledge-sharing, is generally low. For example, it does not publish: information about access commitments, performance measurements or outcomes; outcomes of stakeholder engagement activities or its stakeholder selection process; the results of clinical trials within a specified timeframe; whether it commits to registering all trials; its criteria for making registration decisions, or where products are filed for registration; whether it has issued drug recalls during the period of analysis; the status of its patents, or its position on the Doha Declaration.

Change since 2014
(for Roche only, this section reflects performance changes that are publicly disclosed)

In 2015, rolled out the Access Planning Framework, aiming to identify specific regional and national challenges, and developed more than 60 country-specific access plans.

Shares less information about how it tracks progress toward access-related targets and its approach to stakeholder engagement.

Has improved its compliance system as well as the transparency of its lobbying activities and enforcement processes.

Still does not prioritise access in its R&D commitments or partnerships.

Signed the Declaration by the Pharmaceutical, Biotechnology and Diagnostics Industries on Combating Antimicrobial Resistance.

Has not been found in breach of anti-competition laws during the period of analysis.

Supported hepatitis C awareness raising in Vietnam for World Hepatitis Day in 2014, and in Indonesia in 2015.

In 2014, extended its partnership with the Côte d’Ivoire Ministry of Health to facilitate access to hepatitis B, C and D treatments.

Launched the Roche Pharma Africa Strategy in 2015, acknowledging the need for capacity building in sub-Saharan Africa in collaboration with local partners.

Opportunities

Include other diseases areas in its access efforts. Roche can broaden its existing access initiatives (e.g., for cancer medicines) to improve access to medicine for other diseases, including for products on the WHO Model Essential Medicines List (EML). For example, Roche could build on its cancer-focused partnerships in countries such as Gabon, Indonesia and Kenya.

Ensure affordability for more products. Roche implements equitable pricing strategies for a small proportion of its portfolio. It can expand these strategies to more diagnostics and platform technologies, particularly its HCV diagnostic products, to ensure all relevant products are priced affordably where they are needed.

Agree access-oriented licensing terms for pipeline products. Roche has licensed danoprevir (now in phase II development) for supply in China. When licensing promising pipeline products for supply to emerging markets, Roche can ensure strong access plans are included in the terms and conditions of the partnership agreement (e.g., non-exclusivity, affordability).

Evaluate impact of capacity building efforts in sub-Saharan Africa. Through the Roche Pharma Africa Strategy, the company aims to increase access to medicines for viral hepatitis and women’s cancers. As it works toward this aim, Roche can help ensure effectiveness by evaluating the impact of its initiatives and publishing outcomes.

Sales and operations

Roche is one of the world’s largest biopharmaceutical companies. It works in in-vitro diagnostics, tissue-based cancer diagnostics and diabetes management. It has two divisions: pharmaceuticals and diagnostics. Roche’s pharmaceutical business is focused on oncology, immunology, ophthalmology, infectious diseases and neuroscience. Roche Diagnostics offers a wide range of diagnostics and platform technologies, including molecular diagnostics, clinical chemistry and immunoassays, tissue diagnostics, point-of-care diagnostics and biotech solutions. These diagnostics cover a variety of diseases in scope, including metabolic, liver and heart diseases. As of 2014, it had sales in approximately 90 countries in scope.

Sales in countries in scope
Sales by division
Sales by region

Portfolio and pipeline

Roche has a large portfolio of products for high-burden diseases, and a mid-sized pipeline of projects intended to address the needs of people in countries in scope: with 76 registered products and 14 R&D projects.

Roche has 19 medicines, 46 diagnostics and 11 platform technologies registered for diseases in scope. The majority target viral hepatitis, HIV/AIDS or ischaemic heart disease.

Products per disease category

Approximately half of Roche’s portfolio is focused on communicable diseases.

The company is developing products for five non-communicable diseases (NCDs) and four communicable diseases, with a heavy focus on viral hepatitis. Roche did not disclose products in discovery or pre-clinical stages of development.

A small proportion of its pipeline targets high-priority product gaps with low commercial incentive. including the hepatitis C medicine danoprevir. The Cobas 6800/8800 system was launched in Q4 2014 and approved for HIV/AIDS diagnosis by the FDA in Q4 2015. Roche committed to making its Cobas system available at lower prices in developing countries.

Pipeline projects

Roche is developing a beta-lactamase inhibitor and two medicines for viral hepatitis in partnership. Roche granted Ascletis rights to develop and manufacture danoprevir, in phase II for hepatitis C, in China.

First-line treatments and essential medicines

79% of Roche’s medicines are listed on the EML/or as first-line treatments: e.g., peginterferon alfa-2a (Pegasys®), ribavirin (Copegus®), alteplase (Activase®) and oseltamivir (Tamiflu®).

Pipeline by stage of development
– Innovative medicines and vaccines

Roche has 11 relevant innovative medicines in clinical development. Lebrikizumab, a late-stage product targeting chronic obstructive pulmonary disease and severe asthma, is being tested in countries including Mexico.

Pipeline by stage of development
– Adaptive medicines and vaccines

Roche is adapting products that target kidney diseases and hepatitis B. Both projects include trials in countries in scope, such as Brazil, Colombia and Mexico.

Please refer to the pdf of the report card (that can be downloaded here) for information on Roche’s performance per technical area.

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