French government adamant on imposing sanctions on pharmaceutical companies that report shortages.

Medicine shortage has increased exponentially over the past decade, the reasons for this can be accounted due to the outsourcing of production to subcontractors located in counties where the quality controls are not as strict as in Europe, resulting in more and more frequent supply disruptions.

The National Agency for Medicines and Health Products Safety (ANSM) has previously charged a hefty financial penalty of EUR 348,623 to a pharmaceutical company because it breached its obligation to supply the market in a continuous manner. The ANSM stated that the company has not planned any shortage management plans, presenting a serious and immediate risk to patients.

The ANSM hoped that this decision will underline the responsibility that pharma companies have in regard to supply distribution with response not only vital for the wholesalers.

The above events occurred in February 2019. The Health Secretary of France as of July 2019 is setting up a select committee to help her implement her plan for pharma companies. She hopes to strengthen the ANSM powers to sanction manufacturers who do not have shortage management plans. With penalties for each day of shortage reaching up to a maximum of 30% of the average daily turnover in France.

No comments:

Post a Comment

Coranavirus and its relationship with IP exclusivity

With the global shutdown that has occurred due to COVID-19, its presence has caused long-lasting effects in all aspects of our lives and t...