Pricing and reimbursement of medicinal products and medical devices in Malta

Malta Medicinal Product Pricing and Reimbursement

An examination of the key legal and practical issues surrounding the pricing and reimbursement of medicinal products and medical devices in Malta.

Malta has a unique ‘split’ medicines market, with two separate and distinct regimes, as outlined below.

i The National Health Service

Patients’ entitlement to medication on the public health market (national health services) outside a Maltese government hospital setting is based on the principle of social solidarity. Entitlement is assessed on the basis of disease or means by virtue of the Social Security Act (Chapter 318 of the Laws of Malta).

National health services are funded by taxpayers and managed by the Maltese government (responsible directorates within the Ministry of Health). Medicinal products listed in the government formulary are provided free of charge to eligible patients (end user). Under the entitlement programme, patients have no freedom of choice but are prescribed the medicinal products included in the government formulary.

Requests by medical practitioners (consultants) for medicinal products not included in the government formulary are made on a named-patient basis and may be accepted provided conditions are met and the medicinal product holds a valid marketing authorisation in an EU Member State.

Malta has transposed and implemented the EU transparency laws which apply to medicinal products procured via national health services (i.e., the national formulary). The applicable Maltese law is the Availability of Medicinal Products within the Government Health Services Regulations (SL 458.31).

Malta spends relatively more on outpatient care, long-term care, pharmaceuticals and medical devices than most other EU countries. The relatively high share of spending on pharmaceuticals reflects longstanding challenges in ensuring access to innovative medicines in a sustainable way through public financing sources. Under the Pharmacy of Your Choice Scheme, people with certain chronic conditions are entitled to free medication related to that condition, while people with low incomes (as established by a means test), are entitled to receive certain medicines on the government formulary list free of charge. The Scheme covered approximately one-third of Maltese residents in 2019. However, the majority of the population must pay for other prescribed pharmaceuticals out of pocket, contributing to a high share of pharmaceuticals being paid for from private sources.44

The Malta Community Chest Fund, headed by The President of Malta, funds specialised medical treatment including oncology medicines that are not covered by the government formulary.

 

ii The private market

This essentially services those areas of the healthcare sector that are not covered and supported by the Malta National Health Service. Medicinal products purchased on the private market (i.e., from a pharmacy at retail level) are an out-of-pocket cost to the patient or consumer and, in the case of prescription medicines, are prescribed by a doctor (prescriber) in private practice.

The Maltese private market enjoys a free-market pricing policy. There are no statutory price controls. Private market medicines prices (purchased by the consumer from a pharmacy at retail level) are not fixed by the government, but are determined by the licensed market players in the legal supply chain (pharmacy, wholesale dealer, manufacturer or MAH). A number of privately owned hospitals are licensed to operate in Malta. The price of medicines at retail level are monitored via a referencing mechanism aimed at benchmarking an average consumer price across EU Member States. Out-of-pocket (OOP) spending as a share of total health spending in Malta in 2018 was 34.3 per cent – the fourth highest proportion in the EU and more than twice the EU average. Spending on outpatient care accounted for the largest share of OOP spending.

 

iii Health technology assessment

In January 2018, the European Commission published a Proposal for a Regulation on Health Technology Assessment (HTA) amending Directive 2011/24/EU. The proposal establishes a Member State Coordination Group on HTA (Coordination Group) composed of representatives from national HTA authorities and bodies. The Coordination Group will be responsible for overseeing the joint clinical assessments. Joint clinical assessments (of medicinal products and medical devices) are limited to the most innovative technologies with the most potential EU-wide public health impact.

Published by Lexology on 23 February 2022 as an extract from the Malta chapter of The Life Sciences Law Review 10thedition authored by Dr Anthia A Zammit.