MALTA Law and Practice Contributed by: Deo Falzon, Fenech & Fenech Advocates
trade blocs. These agreements may facilitate regula- tory co-operation and reduce technical trade barri- ers. However, EU regulatory requirements for market access, such as CE marking or GMP compliance, remain applicable irrespective of FTA provisions. 8. Pharmaceutical and Medical Device Pricing and Reimbursement 8.1 Price Control for Pharmaceuticals and Medical Devices Pharmaceutical prices in the public sector are regulat- ed by the Ministry for Health. Reimbursed medicines are included in the Government Formulary List and procured through centralised tendering mechanisms. Price negotiations consider external reference pricing and therapeutic value. Prices in the private sector are not subject to statutory control but may be indirectly influenced by public pricing benchmarks. Medical device prices are not subject to statutory price control in the private market. In the public sec- tor, pricing is determined through competitive public procurement, and evaluations consider both cost and technical merit in accordance with applicable public procurement law. 8.2 Price Levels of Pharmaceuticals or Medical Devices Malta applies external reference pricing for pharma- ceuticals included in public reimbursement schemes, typically benchmarking against prices in other EU Member States. This ensures equitable and sus- tainable access to essential medicines. In the case of medical devices, prices are primarily determined through public procurement and market competition rather than formal benchmarking systems. 8.3 Reimbursement From Public Funds The national Government Formulary List governs pharmaceutical reimbursement. The list defines eligi- bility based on therapeutic need and cost-effective- ness. Medicines are provided free of charge to entitled patients under the national healthcare system.
For medical devices, reimbursement is available for specific categories (eg, ostomy products, insulin pumps, and assistive devices) under defined entitle- ment criteria. Healthcare providers co-ordinate access to publicly funded devices in accordance with clinical protocols. 8.4 Cost-Benefit Analyses The Ministry for Health and advisory bodies conduct cost-effectiveness assessments during the evaluation of new medicines and devices for reimbursement. While Malta does not have a dedicated national health technology assessment (HTA) agency, pharmacoeco- nomic data and budget impact models are considered during formulary decisions. Malta also participates in EU-level HTA initiatives, including EUnetHTA and the implementation of Regulation (EU) 2021/2282 on HTA co-operation. 8.5 Regulation of Prescriptions and Dispensing by Pharmacies The Medicines Act and the Pharmacy and Poisons Act regulate prescribing and dispensing practices in Malta. Key controls include: • mandatory electronic prescribing for publicly funded medicines; • controls on the prescribing of high-cost or high-risk medicines; • promotion of generic substitution where clinically appropriate; and • routine audits of prescribing trends. Dispensing pharmacies must be licensed by the Phar- macy Council and adhere to GPP standards. Reim- bursed medicines must be dispensed in accordance with Government Formulary protocols and patient eligibility criteria.
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