CNMC Challenges Restrictions on Self-Diagnosis Test Sales in Spain
Spain’s National Markets and Competition Commission (CNMC) is contesting regulations that limit the sale of self-diagnostic tests, such as those for COVID-19, pregnancy, and influenza, to pharmacies. The CNMC argues these restrictions unnecessarily hinder competition, potentially increasing prices and limiting access to these important health products.
The Challenge to Royal Decree Regulations
The CNMC has initiated legal proceedings against specific articles within a Royal Decree regulating health products for in vitro diagnosis. Specifically, the commission is challenging provisions that restrict the sale of self-diagnostic tests to physical pharmacies and pharmacy websites, excluding sales through online marketplaces. The CNMC opposes the prohibition of selling these tests through vending machines, a channel permitted for other non-prescription health products.
Impact on Competition and Consumers
The CNMC contends that the current measures are disproportionate, leading to reduced competition, potentially higher prices, and restricted access for consumers. The commission highlights that security, conservation, and traceability requirements can be adequately met by establishments already adhering to stringent standards, such as parapharmacies and drugstores. Existing product leaflets provide necessary usage information, which can be supplemented by advice from pharmacies or healthcare centers.
International Comparisons
The CNMC points to other countries where self-diagnosis tests are widely available in supermarkets, parapharmacies, drugstores, and online platforms. This broader availability fosters competition, lowers prices, and improves access, particularly during periods of high demand, such as the COVID-19 pandemic, mitigating the risk of shortages.
Concerns Regarding Online Sales Restrictions
The CNMC also objects to the limitation of online sales to pharmacy websites, excluding the use of intermediaries or marketplaces, even when those sellers are authorized establishments. The prohibition of sales through vending machines, even within pharmacies, is considered excessive, as this channel could meet the required safety and traceability standards while providing convenient access outside of regular business hours.
Background: Royal Decree 463/2020
The challenge stems from Royal Decree 463/2020, published on March 14, 2020, which declared a state of emergency in Spain to manage the COVID-19 public health crisis. This decree included provisions impacting the sale and distribution of diagnostic tests, which the CNMC now argues are anti-competitive. The initial state of emergency was declared for fifteen calendar days, until March 30, 2020, and could have been extended.
The CNMC had previously voiced concerns about these types of restrictions in reports, including one addressing a draft of the Royal Decree.