Research & Development

Key Trends

• Access-oriented R&D Investment in R&D for diseases that particularly affect the world’s poor is increasing, with the top five ranked companies now orienting more than a fifth of their pipeline towards relevant disease areas.
• Collaborative R&D Companies are increasingly sharing  know-how and intellectual property with the scientific community in the public and private sectors, whether through product development partnerships or other pre-competitive intellectual property sharing mechanisms.
• Ethical clinical trials Few companies have robust measures to ensure clinical trials conducted by contractors are safe and ethical with the majority providing no evidence of exerting real influence over the way their contractors conduct trials or adequate assurance of benefits returned to host communities.

Many companies are investing more in research and development (R&D) than they were in 2010 for diseases that particularly affect people in developing countries. The leaders in this area –GlaxoSmithKline, Sanofi and Johnson & Johnson– invest most heavily in the development of new and adapted products for developing world markets. They are also more transparent than their peers regarding clinical trials conducted in developing countries. These companies, as well as smaller  ones such as Gilead, also invest  heavily in R&D partnerships.

Leaders 

GlaxoSmithKline ranks 1st by quite a wide margin, demonstrating leadership across nearly all indicators. Its pipeline is fuller than previously for new medicines and for adaptive research directed at the needs of the poor, and this is complemented by R&D partnerships and sharing of intellectual property. Its transparency in all major areas of R&D that affect access is better than that of any other company. Its mechanisms for ensuring clinical trials are conducted ethically, including allowing for continued access post-trial to medicines for clinical trial participants, are also superior. 

Sanofi, ranking 2nd, has a good pipeline in both innovative and adaptive R&D that covers a broad range of relevant diseases. At the time f the 2010 Index it had no adaptive products. The company also has numerous R&D partnerships. Compared to 2010, it has  improved its position in relation to ensuring patient access to medicines after clinical trial participation and its disclosure of the results of clinical trials. It shows a strong commitment to ensuring that contract research organisations (CROs) conducting clinical trials on its behalf uphold ethical standards, and follows through by monitoring and enforcing its standards for clinical trial conduct.

Johnson & Johnson has risen by four places to 3rd by adding relevant compounds to its pipeline and through its acquisition of Crucell, which has brought relevant vaccines into its portfolio. A large number of product partnerships and a high level of intellectual property sharing have also significantly improved its position.

Novartis, although dropping three places to 4th, is still among the leading companies in many of the R&D-related  indicators, including making significant investments in R&D for neglected tropical diseases (NTDs), engaging in several relevant R&D partnerships, taking responsibility for the conduct of CROs involved in clinical trials and having in place clear processes for assuring post-trial access  to medicine for trial participants. Despite this, Johnson & Johnson and Sanofi have overtaken Novartis this year because they made relatively better progress since 2010. 

Most improved

Merck KGaA, which jumped six places to 6th, increased investments in both innovative and adaptive R&D with products of both types in the pipeline in 2012, compared to having neither in 2010. The company is also among the leaders in terms of intellectual property sharing relative to company size. It is also one of the few companies to move beyond having CRO codes of conduct to actively monitoring and enforcing them, although it lacks transparency around the details of who those CROs are, clinical trials registration and results.

Eli Lilly, which has likewise improved its position by six places in this Index, also shows a significant commitment to intellectual property sharing for its size and now has relevant new products in the pipeline, whereas at the time of the last Index it had none. The company is one of only four to be relatively more transparent about the details of licences with the Product Development Partnerships (PDPs). Its improved position is also related to its innovative Open Innovation Drug Discovery programme, a web platform to open up data to the scientific community to advance research. However, the company is not fully transparent with respect to its use of CROs. 

Fallers

Some companies that slid in ranking, such as Boehringer-Ingelheim, Pfizer, Bayer and AstraZeneca, have no significant relevant investments in Phases II and III trials and fare poorly against the more stringent indicators relating to clinical trials conduct. For example: 

• Pfizer, dropping six places to 11th, does not perform well across many measures related to enhancing the safety of developing world clinical trials, and scores poorly in terms of transparency about trial registration details, use of CROs and clinical trial results. The company’s score was also affected by a clinical trial regulatory breach in Nigeria.
• Bayer, declining five places to 16th, has no relevant innovative compounds in its pipeline and performs poorly against many measures around ethical clinical trials conduct. It provides no evidence of conducting due diligence prior to using CROs or of robust methods for controlling them. It also applies access-oriented licence terms to only two out of four research collaborations. 
• AstraZeneca, declining four places to 12th, still has limited R&D relevant to developing country needs.