Human rights in approval process

After the development phase, a registration file containing the detailed results of all the research conducted on the compound and its formulation is submitted to local or regional health regulatory authorities in charge of assessing the efficacy and safety of the drugs. If analysis proves that the benefits outweigh the risks for a specific disease pattern, and if all regulatory requirements are fulfilled, the regulatory body authorizes the drug to be marketed.

The price of the drug is then either set by health authorities or independent committees based on diverse methods that vary according to countries and healthcare systems, such as the cost-effectiveness ratio, reference pricing (in countries where the prices of drugs are regulated), or set directly by the pharmaceutical company.

 
  • Commit to taking a responsible
    approach to lobbying
  • Fight against corruption and prevent
    conflicts of interest during interactions
    with third parties
  • Compensate for lengthy drug approval
    processes and ensure the timely availability
    of drugs for identified patients' needs
  • click to see examples
  • Expand the offer of affordable
    drugs for lower-income and
    disadvantaged patients

Key Stakeholders


Patient and
patient associations 

Healthcare professionals
and scientific community 

Competitors 

Health authorities, governments
and international institutions 
NGO
NGOs and
non-profit organizations 
 
 

Examples of Sanofi's good practices

Coordinate pricing policies with health authorities,
reimbursement bodies and NGOs to make existing
drugs affordable for patients.

Develop and market specific healthcare products
and services for lower-income patients.

  • Sanofi set up a tiered-pricing policy for its antimalarial
    medication in 2007 with a “no profit-no loss” price of
    less than $1 for adults and $0,50 for children. Over
    95% of our antimalarial medication has been sold
    on this basis in the global fight against malaria.
  • Sanofi India Limited launched AllStar™ in 2012,the
    first Indian-manufactured, re-usable insulin pen
    designed for affordability and user convenience
    to combat diabetes in emerging markets.
     

Human Rights


Right to health

Right to benefit from scientific progress