National authorities in France and Ireland were due to negotiate the conclusion of replacement, multi-year pricing agreements with their respective pharmaceutical industries by mid-2020.
However, where possible, healthcare systems in France and Ireland are redeploying every financial and personnel resource they have to mitigating the impact from coronavirus COVID-19. HSE staff have been re-tasked to COVID-19 related duties and the French National Authority for Health (Haute Autorité de Santé: HAS), and the CEPS which is within the Ministry of Health, is also on an active emergency footing.
A price-setting framework agreement between France’s Economic Committee of Health Products (Comité Économique des Produits de Santé: CEPS) and the French Pharmaceutical Companies Association (Les Entreprises du Médicament: LEEM) has already been extended on two occasions. The terms of the three-year agreement were originally due to expire on 31 December 2018. Both sides subsequently agreed to a one-year extension until 31 December 2019 while negotiations continued. A second extension was adopted with the mutual consent of LEEM and the CEPS in December 2019, with the extension period scheduled to expire in July 2020. For its part, a four-year price-reduction agreement between the Irish Pharmaceutical Healthcare Association (IPHA), the Health Service Executive (HSE) of Ireland is valid until July 2020. After this date all agreement obligations shall cease unless continued by mutual agreement of the parties, given to each other in advance.
There is evidence from other sectors that COVID-19 has the potential to cause delays for the pharmaceutical industry. One testable manifestation of this are slowdowns in clinical trial activity. A small number of companies have so far halted studies owing to the impact on trial integrity, deviations in protocol as well as severe short-term difficulties in recruiting and monitoring participants effectively.
But multiple other areas of pharmaceutical regulation may eventually experience similar consequences.
The canary in the coal mine may be how talks on pricing framework agreements in France and Ireland proceed. Should negotiations even continue to take place during times of unprecedented pressure on healthcare systems or will authorities seek to defer the negotiating process into the second half of 2020? The pharmaceutical industry also has significant amount at stake. Aside from the logistical difficulty of avoiding face-to-face negotiations, and the possibility of COVID-19 infections among key staff, there is the challenge of how best to present the delivery of potentially controversial framework deals to the public during a time of national emergency and what concessions may need to be offered. The need for a second extension of the LEEM/CEPS multiyear framework agreement in December was not a positive sign for the state of the negotiations between the two sides. And it would be an unparalleled situation for the LEEM and CEPS to opt for a third extension – taking the total delay beyond 19 months, as of July 2020. Nevertheless regulators and health systems are in unprecedented times.