On 24 September 2019, the lower house of the Czech parliament conducted a second vote on a draft Amendment to the Pharmaceuticals Act (No. 378/2007 Coll.), which was returned to the chamber after a vote in the Czech Senate in late July.
The lower house rejected all the changes suggested by the Senate and approved the Amendment in its original wording. The amended law is currently awaiting a signature by the Czech President.
Together with new rules on digitalising the healthcare system through the “eRecept System” (offering an “opt-out” option for patients), the lower house also approved changes to the rules on how marketing authorisation holders (MAHs) supply pharmaceuticals to distributors.
Under the new rules, MAHs are obliged to supply distributors who offer written statements requesting pharmaceuticals for patients in the Czech Republic. In this case, each MAH will supply a sufficient volume of pharmaceuticals to the distributor to meet the average orders of its pharmacies for a least a two-week period.
Distributors requesting a supply of pharmaceuticals with the written statement must supply pharmacies within two business days from receiving an order and cannot export these pharmaceutical products abroad.
As explained in our Law-Now article in August, the Czech Ministry of Health is currently preparing new rules under an “Emergency System” regarding the availability of pharmaceuticals in the country. Under the Emergency System, pharmacies will have the right, under certain conditions, to order pharmaceuticals directly from a MAH, who must fulfil the order within two business days.
In addition, the recently passed Amendment allows for medical cannabis to be covered by public health insurance for up to 90 percent of its price, which will be regulated and its maximum surcharge capped by the State Institute for Drug Control. These new regulations were introduced to prevent excessive use of cannabis and its leakage to the black market.
Law-Now will follow the legislative process and keep you updated. For more information on this Amendment and opportunities in the Czech pharmaceutical industry, contact your usual CMS source or one of the following local CMS experts:
See Law Now article of 2 August 2019 here for previous coverage on the Amendment.