Public service obligation: Article 81 supply duty of holders and distributors

Article 81 of Directive 2001/83/EC, second paragraph, requires the marketing authorisation holder and the distributors of a medicine actually placed on the market in a Member State to ensure, within the limits of their responsibilities, appropriate and continued supplies to pharmacies and persons authorised to supply medicines, so that the needs of patients in that Member State are covered. The first paragraph adds that Member States may not impose stricter obligations on wholesalers from other Member States than on their own. The provision is deliberately general and leaves it to national law to say what appropriate and continued means.

Member States have used it in very different ways. Some set stock-holding duties on holders and wholesalers, measured in weeks or months of average demand. Others require wholesalers to serve all pharmacies in a territory, restrict exports of medicines on a national shortage list, or make holders justify supply allocations. The Court of Justice has accepted such measures where they are proportionate and justified by public health, which gives the obligation its teeth: a holder that cuts supply to a market to favour parallel export elsewhere can face enforcement under Article 81 as implemented nationally.

For a regulatory team the obligation is the counterpart to the shortage notification. A product counts as placed on the market once marketing starts, so the duty to supply follows the marketing status data the holder reports to authorities. Supply quotas to wholesalers, which the Court has allowed in principle, must still leave the national market covered, and every allocation decision should be documented against expected demand.

What goes wrong: a dormant authorisation that commercial teams revive with a small launch, which triggers the supply duty without anyone planning stock; parallel export that drains a market without the holder noticing; and wholesaler agreements that ignore national stock rules. Authorities now cross-check supply data from wholesalers, shortage portals and marketing status reports, so inconsistencies between them surface quickly.

Under the new pharma package (not yet in force), the supply duty is reinforced with longer notice periods before a cessation, shortage prevention plans for prescription medicines, and extra obligations for products on the Union list of critical medicines, including a duty to offer to transfer the authorisation before withdrawing a critical medicine; see shortages changes.