On June 27 the third edition of our new global series, Life Sciences and Health Care Horizons, took place in Paris with discussions focused on the pricing and financial regulation of health products after the latest reforms. We are excited to share the following highlights from Paris, and we look forward to future discussions as we forecast and help clients prepare for what's to come.
In its June 2019 report on the situation and prospects for public finances, the French Cour des Comptes (the supreme body for auditing the use of public funds in France) warned of the risks to social security expenditure as early as 2020. Ongoing and additional pressures will therefore be placed on pharmaceutical companies and medical device manufacturers. The French Government should continue to use its legislative and regulatory tools, in particular the claw-back clause [clause de sauvegarde] and the various claw-backs mechanisms.
In this context, our panelists stressed the importance of strategic thinking when considering early market access, in particular taking into account recent developments in financial regulatory mechanisms. They then exchanged views on how to challenge unfavorable health technology assessment and conduct price negotiations.
The "temptation" of early market access: advantages and disadvantages
Mikael Salmela, partner in our European Life Sciences Regulatory practice, first recalled the early market access regimes in France: Nominative Temporary Authorizations for Use (nATU) and Cohort Temporary Authorizations for Use (cATU). Mikael then stressed the need for in-depth strategic thinking before opting for an early market access route. Before the entry into force of the French Health Insurance Fund Financing Act (hereinafter the "Financing Act") for 2019, ATUs were granted per medicinal product and only before the first marketing authorisation (MA) for the product in question. This regime did not meet market demands, particularly in oncology where additional therapeutic indications can be quickly developed. The Financing Act for 2019 extended the early access regime to new therapeutic indications (i.e. extensions of indications) after the granting of the MA. From now on, cohort ATUs are delivered by therapeutic indication. Market access can therefore be achieved in successive phases, therapeutic indication by therapeutic indication. Regulatory texts are expected to clarify the contours of this new regime.
Mikael presented the application...