Sanofi-Aventis has instituted rapid registration programs in a large number of Index Countries in need and also instituted equitable pricing mechanisms for its 2007 anti-malarial (ASAQ) drug.
Compared to peers, the company has one of the largest numbers of products in its R&D pipeline focused on communicable Index Diseases.
Sanofi-Aventis is continuing one of the largest ever Phase IV trials (expected to enroll over 20,000 patients) in sub-Saharan Africa for ASAQ, with a stated objective of facilitating the strengthening of local pharmacovigilance infrastructures.
Changes Compared to Index 2008
The company terminated the intra-country pricing initiative the "Anti-malarial Drug Access Card (CAP)" due to "administrative complexities" In six countries and over four years, the program had reached over 80,000 patients. The company states that it will instead deliver its malaria medicine through the Global Fund's 'Affordable Medicine Facility – malaria (AMFm)'.
Since the release of Access to Medicine Index 2008, Sanofi-Aventis has continued to improve its ATM transparency with significant progress in disclosing comprehensive future ATM program targets and public policy positions relevant to ATM.
The company was involved in one of the cases of seizure of generic drugs in the Netherlands based on the European intellectual property rules. The shipment of the product which is patented in the Netherlands by Sanofi-Aventis was detained based on company's request and released after a few months.
Suggested Areas for Improvement
The company makes no specific commitments or disclosure on quality management and capability advancement in the Index Countries, despite its expanding (20 to 25 sites) Index Country operations.
The company has exhibited low transparency on the terms and conditions of its R&D collaborations in areas such as pricing for the products it has developed, across different geographies and supply channels.
The company does not undertake any non-exclusive voluntary licensing activity.