Andorra Approves Draft Law to Modernise Pharmacy Regulations, Curb Commercialisation

The Andorran government has approved a draft pharmaceutical regulation law aimed at modernising an outdated framework for the sector. The bill, which still requires regulatory development and parliamentary approval, sets strict rules on pharmacy ownership, operations and oversight to emphasise their role as a community health service rather than a commercial enterprise.

Under the proposed law, pharmacies may be owned by individuals or companies based in the Principat, but corporate owners must consist solely of qualified pharmacists. A single company faces a cap of six outlets, with each requiring a licensed pharmacist holding their own independent authorisation at the helm. This limit reflects the current landscape, where groups like Pasteur and Galeno already operate six pharmacies each.

The legislation bars prescribing health professionals—such as doctors, dentists or veterinarians—from any direct or indirect financial stake in drug manufacturing, distribution or sales. It also excludes those involved in pharmaceutical production, distribution or inspection from pharmacy ownership. Incentives like discounts or bonuses to influence prescriptions or sales are prohibited across the board to safeguard professional independence.

Staffing rules mandate a qualified pharmacist on site during all opening hours, in roles including titular, co-titular, responsible manager, deputy, regent or substitute. Other employees must receive specific training for tasks like drug storage, handling or dispensing. Pharmacists are obliged to flag suspicious prescriptions, report errors—such as drug incompatibilities—and prevent fraud.

A tiered sanctions regime accompanies the bill, with fines ranging from €300 for minor issues like poor signage or hygiene lapses to €200,000 for very serious violations, potentially including closure for up to five years or permanently. Serious offences, penalised up to €20,000, cover failures like breaching guard duties, improper drug storage, selling prescription drugs without a script, unauthorised online sales or excessive advertising. Repeat minor infractions escalate to serious status, while very grave cases involve sourcing unauthorised drugs or endangering public health. Fines may increase if illicit profits are linked to violations.

Health ministry inspectors gain explicit powers for unannounced visits, document access and sampling to enforce compliance. The government has 12 months from enactment to detail inspection procedures, six months for pharmaceutical planning and 12 months for prescription and dispensing rules.

A transitional clause allows existing pharmacies to relocate within their parish if they meet distance criteria—60 metres for voluntary moves, potentially less for forced relocations due to unsustainable rent hikes—without breaching population-based limits. Currently, Andorra has 57 pharmacies serving its needs.

The Official College of Pharmacists (COFA) has welcomed the draft, describing it as a positive step after years of negotiations to "avoid mercantilism." President Jesús Robinat stressed that pharmacies are "not a business, but a health service," crediting the 100% Andorran and pharmacist capital requirement for enabling locals to work while filtering out external commercial pressures. He noted the bill maintains some status quo, such as allowing a new pharmacy to open within five years if one closes, after which unmet demand could reduce the baseline number of outlets.

Robinat anticipates swift executive and parliamentary processing, with no major dissent among the profession's 80-plus members. Future priorities include a medicines law, supply assurances and fairer on-call pay, currently under €3 per hour on weekdays and slightly more on holidays. The bill makes no provisions for potential EU association impacts, which remain uncertain.