Member Article

Pharmaceutical companies are meeting with numerous legal challenges resulting from the ongoing COVID-19 pandemic and the corresponding Government measures. Among the most discussed topics are the legal obligations relating to availability of medicinal products, securing of medicinal products for treatment of patients with COVID-19, control over the distribution channel, clinical trials, and relations with healthcare professionals.

AVAILABILITY OF MEDICINAL PRODUCTS

During the COVOD-19 pandemic, legal obligations of marketing authorisation holders and wholesalers relating to availability of medicinal products are of utmost importance. Even though these measures have applied regardless of the pandemic, in the present situation, they should be given proper attention.

1. Availability in sufficient quantity A marketing authorisation holder of a medicinal products listed in the list of reimbursed medicinal products is obliged to ensure availability of the product in sufficient quantity, being the stock sufficient to cover the estimated monthly consumption in the Slovak Republic, calculated based on:

• the actual consumption of medicinal products in the same reference group (same active substance, way of administration, drug form, and amount of active substance) for the last calendar quarter,
• the actual consumption of medicinal products in the same reference group for the calendar quarter preceding by 12 months the relevant time, in case for products for seasonal use,
• • estimated consumption according to pharmaco-economic analysis, in case for products listed in the list of reimbursed medicinal products for less than six months not belonging to any pre-existing reference group at the time of entry to the reimbursement list, or
• estimated market share.
  
  

The requirement does not apply to orphan drugs. Seasonal products must be available only in the respective season. Breach of this obligation is not subject to any fine, however, if a product is not available in sufficient quantity for 60 consecutive days, the Ministry of Health may delete it from the list of reimbursed medicinal products.

More you can read in our PDF document.