The Healthcare Law Review: Malta
Malta is the European Union's (EU) smallest Member State and has implemented all EU legislation. Malta's population, comprising less than half a million people, enjoys generally good health and one of the longest life expectancies in the EU. However, high obesity rates among adults and adolescents pose a serious threat to public health. The National Health Service provides universal coverage for a comprehensive benefit package, while the private sector plays a key role in the delivery of primary care.
Malta recorded one of the largest increases in per capita health expenditure in the EU during the past 10 years. Health spending per person in 2017 was €2,732, more than 60 per cent higher than in 2007, although it remains below the EU average. This equates to 9.3 per cent of the GDP, also below the EU average of 9.8 per cent. Although the health system provides practically universal coverage, out-of-pocket spending in 2017 was the joint fourth highest in the EU (34.6 per cent compared to an average of 15.8 per cent), due to high private spending on outpatient services, primary care, and pharmaceuticals.2
The healthcare economy
i The Maltese healthcare market
Malta has a two-tier or split healthcare service market, with two separate and distinct regimes that operate in parallel.
The national health service
The public healthcare system is funded by the state. Patients' entitlement to medication on the public health market (national health services) outside a Maltese government hospital setting 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 (the Ministry for Health). Medicinal products listed in the government formulary are provided free of charge to eligible patients (end user).
Malta has transposed and implemented the EU transparency laws that 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).
The private market
This services the healthcare sector that is not covered and supported by the Malta National Health Service and operates independently of the Malta National Health Service. Medicinal products for human use purchased on the private market (i.e., from a pharmacy at retail level, sold to the pharmacy by the wholesale dealer) are an out-of-pocket cost to the patient or consumer and, in the case of prescription medicines, are prescribed by a doctor.
ii The role of health insurance
Taxes fund Malta's public healthcare system. Malta provides healthcare services, which are free at the point of delivery to all Maltese citizens and European Union residents with a European Health Insurance Card (EHIC), although the EHIC is not considered an adequate substitute for comprehensive health coverage.
In order to be eligible for Maltese citizenship under Malta's Individual Investor Programme (IIP), applicants must, along with satisfying other requirements, have a global health insurance coverage of at least €50,000 and must provide evidence that they can maintain it for an indefinite period for all applicants and each of their dependents. The Maltese Health Ministry advises foreign residents to take out private medical insurance.
iii Funding and payment for specific services
Malta's health system is a tax-financed national health service that provides practically universal coverage to all residents covered by social security legislation or humanitarian exemption. Most healthcare services are provided free at the point of use. Medicinal products prescribed by physicians during inpatient care in public hospitals and generally three days post-discharge are available free of charge at point of delivery to entitled persons and for outpatient treatment for certain chronic conditions. Other medicines and medical devices must be paid for out of pocket. Per capita spending on pharmaceuticals and medical devices is high, constituting 21 per cent of total spending, and is higher than the EU average.
Projected government spending increases due to population ageing pose some fiscal sustainability risks in the long term. Reorienting service delivery away from hospitals towards primary care to improve efficiency and reduce public spending remains a priority for Malta.
Primary/family medicine, hospitals and social care
i Delivery of healthcare services
Public health governance, regulation, and financing are centralised under, and managed by, the Ministry for Health. The Ministry is also the main provider of public healthcare services, with the private sector complementing provision, especially for primary care and outpatient services.
Strengthening primary care to improve efficiency and better serve those living with chronic conditions is an important policy goal. Projected spending increases due to population ageing pose some fiscal sustainability risks in the long term. Reorienting service delivery away from hospitals towards primary care to improve efficiency and reduce public spending remains a key priority for Malta.
ii The role of the private sector
Inpatient care is provided mainly by Malta's only 'regional' public hospital, Mater Dei, with primary and outpatient care delivered by both public and private providers. Long-term care for older people is delivered by the public and private sectors as well as by religious (Roman Catholic) organisations. The private sector plays an important role in the delivery of primary care despite the existence of a state-run primary care system. Private General Practitioners (GPs) account for 70 per cent of primary care visits.
For the past 25 years the largest private hospital in Malta has been the St James Hospital Group based in four different locations in Malta, offering in-patient and out-patient services, the immediate medical care unit (IMCU), a pharmacy, surgical interventions, and physiotherapy.
iii Access to medical consultants
Hospital consultants see patients following a referral from a GP (both from the private and public sectors) or other doctor. Many patients opt to pay out of pocket to see private specialists without a referral to avoid long waiting lists in the public sector. This creates a 'two-tier' system, with private-sector GPs and specialists working in both the public and private sectors being able to refer patients back to public-sector services.
iv Data protection laws
The EU member states' data protection law has been significantly strengthened by the EU General Data Protection Regulation (GDPR). The GDPR came into effect on 25 May 2018 and has direct effect and therefore did not require transposition into Maltese law.
v Universal electronic medical records
Data processing in the myHealth website is in compliance with the provisions of the Data Protection Act (Chapter 440 of the Laws of Malta). The website allows Maltese citizens and their doctors to view medical records. Patients with a Maltese electronic identity card, or e-ID, can log in to view case summaries, upcoming appointments, Pharmacy of Your Choice entitlement, and when released: laboratory results, and medical imaging reports. Doctors linked to the patient through the myHealth website can see patients' results and reports as soon as they are published.
The licensing of healthcare providers and professionals
i Institutional healthcare providers
Licensing of private medical clinics
The main legislative instrument for the licensing of private hospitals and daycare medical clinics is the Licensing of Private Medical Clinic Regulations (SL 458.23). Medical practitioners consulting rooms are explicitly excluded. Licence applications are made in writing to the Health Minister and sent to the Ministry for Health. The licence may be refused for any of the reasons listed in the Regulations and the issuance of a licence is subject to conditions, including the number of patients that can be treated.
Revocation of licences
Article 5 of the Private Medical Clinic Regulations states:
- The Minister may refuse to issue or renew, or may withdraw a licence in respect of a clinic if he is satisfied -
- that the applicant, or any person employed or proposed to be employed by the applicant to assume responsibility for the clinic is not of good conduct; or
- that for reasons connected with the physical location, construction, state of repair, accommodation, staffing or equipment, the clinic is not fit to be used as a clinic; or
- that the clinic is, or any premises used in connection therewith are, used, or proposed to be used, for purposes which are not related to the clinic or which are in any way improper, unethical or not lawful; or
- that the clinic or any premises to be used in connection therewith consist of or include works executed in contravention of the Development Planning Act; or
- that the arrangements for the management and control of the services provided at the clinic are not adequate.
Where a licence has been refused or is not renewed or has been withdrawn, the applicant or licensee, as the case may be, may within 30 days of receipt of notice of refusal, non-renewal or withdrawal of licence, appeal to a tribunal to be appointed by the President of Malta and made up of a person who has, for at least seven years, been in possession of a warrant to practise the legal profession in Malta as chairman, and two other members, one from among the medical profession and the other who shall be a representative of the department.
ii Healthcare professionals
The Health Care Professions Act (Chapter 464 of the Laws of Malta) regulates the licensure, registration, and conduct of healthcare professionals.
Medical practitioners, dental surgeons, pharmacists, and midwives must be in possession of a licence issued by the President of Malta, fulfil Maltese/EU citizenship or work authorisation criteria, be of good conduct, and must be registered as a member of the profession by one of the following relevant councils:
- the Medical Council;
- the Pharmacy Council;
- the Council for Nurses and Midwives; and
- the Council for the Professions Complementary to Medicine.
A 'specialist' means a medical practitioner or dental surgeon whose name is included in the relevant part of the specialist register kept by The Medical Council in accordance with the Health Care Professions Act. Inclusion in the specialist register is subject to conformity with qualification and accreditation requirements prescribed by EU and Maltese law.3
In Malta, registered pharmacists should carry out at least one of the functions listed in the regulations, such as the preparation of the pharmaceutical form of medicinal products, manufacturing medicinal products, and dispensing to and supporting patients. The concurrent practice of medicine, as a medical practitioner, and pharmacy is not permitted.
All countries in the WHO European Region, including Malta, require a licence to open and operate a community pharmacy. In Malta the licence is attached to a specific location and premises, subject to inspection before the license is issued by the national authority – in Malta's case, the Superintendent of Public Health. The law imposes obligations on owners or licence holders of pharmacies, who may be non-pharmacists. The official title to designate the responsible pharmacist is 'managing pharmacist'.
A pharmacist that takes up or ceases his or her obligations as responsible pharmacist (RP) must inform the Medicines Authority.
Malta has a community pharmacy monopoly on the dispensing of all medicinal products to patients, including over-the-counter medicines.4
In the Maltese legal system, doctors may be charged with a criminal offence, or sued through the civil court. A doctor may also be a witness to a criminal act and may be required to give evidence in Court, or may even be ordered by the Court to compile a medical report which would include within it factual medical evidence consisting of a diagnosis, treatment and sometimes an opinion about medical facts.
Under the Maltese legal system, doctors may be charged with a criminal offence, or sued through the civil court. A doctor may also be a witness to a criminal act and may be required to give evidence in Court, or may even be ordered by the Court to compile a medical report which would include within it factual medical evidence consisting of a diagnosis, treatment and sometimes an opinion about medical facts.
The law subjects the doctor to a degree of responsibility that is to be expected from a person who has prepared himself or her self and presents himself or herself as competent and able to exercise that particular profession. Article 1038 of the Civil Code expressly establishes that: Any person who without the necessary skill undertakes any work or service shall be liable for any damage which, through his or her lack of skill, he or she may cause to others. Article 1031 of the Civil Code states that every person is liable for the damage that occurs through his or her fault and Article 1032 goes on to state that (1) a person shall be deemed to be at fault if, in his or her own acts, he or she does not use the prudence, diligence and attention of a bonus pater familias, (2) no person shall, in the absence of an express provision of the law, be liable for any damage caused by want of prudence, diligence, or attention in a higher degree.
i Notable cases
Medical malpractice court cases are few and far between in Malta compared to other jurisdictions as these cases increasingly tend to be settled outside of court. Maltese judgments have set fundamental principles, as seen in the case Victor Savona proprio et nomine v. Dr Peter Asphar et dated 2 April 1951. Here the Court of Appeal confirmed the judgment of the Court of First Instance and found the doctor guilty of negligence (in colpa) for not having used the diligence of a bonus pater familias. In this case, a minor suffered permanent disability after his leg had to be amputated as it was infected with gangrene following an operation. The doctor failed to visit and examine the patient the next day after the operation was performed on the minor, even though this was of absolute necessity as the risk of gangrene is imminent in such situations.
In Hucks v. Cole decided in 1968, Lord Denning said that a doctor is liable when he [or she] falls 'below the standard of a reasonably competent practitioner in his field so much so that his conduct might be deserving of censure or inexcusable'. Not all mistakes made by a doctor may fall under medical malpractice. It is only culpable negligence that is punishable by law. The duty owed to the patient is a fair and reasonable standard of care and competence of a physician or surgeon. The law does not require the very highest standard of care and competence. This line of thought is reflected in the case Josephine Borg v. Dottor Anthony Fiorini decided by Judge Godwin Muscat Azzopardi, 18 July 1994 where the doctor was found not to have caused or contributed in any way to the death of the patient.
A Maltese judgment that clarifies the role and responsibility of the physician is In Bezzina Perit Alexander et v. Mizzi Joseph noe, decided by the First Hall, Civil Court on 3 October 2003; the Court stated that architects, doctors, and lawyers do not render work, but provide a service. Therefore, it is not their duty to carry out what was requested by their client, but to do all that is within his or her capacity to achieve the proper end result. The court went on to give an example that a contractor hired to build a house must complete this task successfully, otherwise that contractor will be held liable for damages. However, a lawyer who loses a case, or a doctor whose patient dies, is not responsible for damages as long as he or she has acted in accordance with the rules and principles that govern and are established by his or her profession.
Ownership of healthcare businesses
In 2016, the Maltese government entered into a controversial public-private partnership to transfer responsibility for the refurbishment, development and management of three public hospitals to a private contractor. This created a purchaser-provider spilt in the hospital sector with the Ministry of Health acting as a commissioner of services when it comes to these three hospitals. It was marketed as enhancing medical tourism and constructing a new medical school on the island of Gozo. Construction and capital investment have been delayed. The deal underwent much public scrutiny over transparency of ownership, with the original contractor entering insolvency after receiving €150 million without delivering on obligations. The contract was investigated by Malta's National Audit Office and Part 1 of its reports was published on 7 July 2020.5
In 2018, the partnership was transferred to Steward Health Care, the largest private hospital operator in the United States, and a revised delivery timeline is under negotiation. The Ministry for Health is developing capacity building in service commissioning through a project funded by European Structural Funds.6 In a condensed interview with the Times of Malta published on 20 July 2020, the US Embassy in Malta expressed its interest is in supporting the negotiations in any way they can to help find a solution, stating that this is a significant foreign direct investment that the US would like to 'hold on to' and 'make sure it is clean'.
Commissioning and procurement
Malta's National Health Service offers a comprehensive benefit package, with public healthcare services and emergency dental care available free of charge at the point of use. While medicines prescribed during hospital stays and three days following discharge are available free of charge to the end user, all other pharmaceuticals must be paid for out of pocket by people not eligible for free medication under the entitlement rules of the Social Security Act (Chapter 318 of the Laws of Malta).
Medicinal products and medical devices are procured by the government's Central Procurement and Supplies Unit (Ministry for Health) by tender and provided to patients for chronic conditions as defined by law and for a number of items. Vouchers to purchase gluten-free food are provided for people suffering from coeliac disease. The Government Formulary List lists the medicinal products that are available free of charge to patients according to law. Approximately one third of the Maltese population was covered for at least one chronic condition in 2019.
Marketing and promotion of services
Anti-bribery and anti-corruption laws are governed by the Criminal Code (Chapter 9 of the Laws of Malta), and the Prevention of Money Laundering Act (Chapter 373 of the Laws of Malta).
The Pharmaceutical Research-Based Industry Malta Association (PRIMA) is a member of the European Federation of Pharmaceutical Industries and Associations (EFPIA) and has established a national code applicable to all its members, based on the EFPIA Code of Practice for healthcare professionals (HCPs).
According to the Ethics of the Medical Profession Regulations (SL 464.17), practitioners cannot publicly endorse any particular commercial product or service.7 Conducting commercial enterprise of medicines can result in the doctor's erasure from professional registers.8 SL 464.17 stipulates that doctors ensure their professional independence and must not accept conditions that could jeopardise it.9
The Medicinal Products (Advertising) Regulations (SL 458.32), which transposes European Council Directive 24/2007, lays down a regulatory framework for the promotion of medicinal products and gift provisions to HCP prescribers.
Future outlook and new opportunities
i Medicine pricing: the Valletta Group
Under the purview of the Maltese Health Minister and Deputy Prime minister Chris Fearne, Malta hosted a Valletta Group meeting in July 2019 with a mandate to move forward on a collaborative framework for price-information sharing to undertake collective negotiations on regional prices for bulk purchases of medicinal products in Europe, with the ultimate objective of reducing prices. The Valletta group is named after the 2017 Valletta Declaration in which 10 EU countries, representing 160 million citizens, agreed to work together to leverage pharmaceutical industry negotiations.
ii Heart disease and cardiology
Gains in life expectancy have been driven by a significant reduction in the mortality rate from cardiovascular diseases, which fell by almost 50 per cent between 2000 and 2016. The GUCH (grown-ups with congenital heart disease) clinic at Mater Dei Hospital in Malta is based on British emeritus professor of cardiology Jane Somerville's model. Professor Somerville defined and pioneered the subspeciality of GUCH and was chosen as the physician involved with Britain's first heart transplantation in 1968.
iii Rare diseases
There are particular challenges with accessing medicinal products for rare diseases. In 2018, a special committee was established to assess requests for exceptional medicinal treatment. The Exceptional Medicinal Treatment (EMT) Committee Regulations (SL 528.08) cater for medicinal treatment provided to patients suffering from diseases for which medicinal treatment is not listed on the Government Formulary List; or listed on the Government Formulary List but not according to protocol, indication or prescribed criteria; specifically branded medicines; or medicines for the treatment of rare diseases.
The Exceptional Medicinal Treatment Committee (EMTC) assesses requests submitted to the Directorate for Pharmaceutical Affairs of the Health Ministry by medical consultants by a prescribed application form. Department of Health Circular 15/2018 (DH 417/2018) comprises the policy addressed to healthcare professionals outlining the procedures, the EMT Request Form, the EMTC Terms of Reference, and the Schedule of Review Criteria. Implementation has, however, stalled due to difficulties in determining whether new medicines should be fast-tracked through the exceptional route or added to the regular entitlement package.
At the time of writing, Malta has had exceptionally low mortality from covid-19 infections to date (nine in total). The University of Malta Pharmacy Department, headed by Professor Lilian Azzopardi, and the Malta Medicines Authority, headed by Professor Anthony Serracino Inglott, held a series of scientific online webinars during spring 2020 to share the latest research discoveries and develop cross-disciplinary collaboration.
Maltese research (pre-print) conducted by Professor Yves Muscat Baron indicates that common to the countries and cities that appear to have contained the pandemic are environmental factors including the levels of particulate matter (PM2.5) and ambient salinity. The results show that high levels of PM2.5 in the presence of low ambient salinity may increase the risk of covid-19 infection in the population. Therefore, addressing these two environmental factors may attenuate the severity of the pandemic.
Malta has joined the Inclusive Vaccine Alliance, which aims to negotiate the price and availability of a covid-19 vaccine. EU member states Germany, France, Italy and the Netherlands signed an agreement with pharmaceutical group Astra Zeneca to guarantee the supply of 300 million doses of a possible coronavirus vaccine.
Deputy Prime Minister and Health Minister Hon Christopher Fearne stated that the collaboration between member states via the Inclusive Vaccine Alliance and the European Commission's initiative to secure and negotiate vaccine pricing shows that EU member states are 'working together to access the vaccine rather than competing against each other, which is an ideal scenario for smaller states like Malta'.
The three main areas of concern are:
- the registration of medicinal products in Malta due to joint-labelling and one third of all medicines registrations being authorised under Article 126a of Directive 2001/83/EC of the European Parliament and of the Council of 6th November 2001 on the Community Code relating to medicinal products for human use;
- the medical training and mutual recognition of professional qualifications between Malta and the UK; and
- the Reciprocal Health Agreement, which waives the health costs of UK citizens living in Malta in exchange for the UK's uptake of highly complex cases that Malta refers to the UK. This was in force prior to Malta's EU accession.
Access to innovative medicines
As a small island, Malta faces great challenges in ensuring availability of new medicines for patients. Greater use of managed entry agreements, clinical pathways, and protocols for the evaluation of new medicines have helped facilitate access. Decisions on whether to add new medicines to the Government Formulary List are supported by a Health Technology Assessment (HTA) system established in 2010, which applies maximum reference pricing and external reference pricing and assesses whether procedures deliver value for money. Malta is also a member of EUnetHTA, which supports collaboration between European HTA organisations. Nevertheless, major challenges remain in obtaining funds for new medicines to enter the formulary. Most of the medicines in Malta are authorised via the Article 126a mechanism.
In 2018, the list of medicines included in the Government Formulary List was expanded. Patients with hepatitis C are eligible to receive direct-acting antiviral therapy treatment paid for by the government, while medical cannabis was decriminalised for the treatment of chronic pain, chemotherapy side effects, and multiple sclerosis.10
The Malta Medicines Authority calls for stronger European collaboration, use of generics and biosimilars, and the work of the committee for rare illnesses as recommended strategies to improve access to new medicines. Incentives for biosimilar prescription and substitution at pharmacy level are policy options that could enhance uptake. Acceptance and trust of biosimilar medicines by patients and health professionals remain important.
1 Anthia A Zammit is the founding partner of AnthiaZammit Legal.
2 State of Health in the EU, Malta, Country Health Profile 2019, World Health Organization.
3 Health, Bioethics, and the Law, Cauchi, Aquilina, Ellul, Malta University Press, 2006.
4 The legal and regulatory rramework for community pharmacies in the WHO European Region, World Health Organization.
5 An audit of matters relating to the concession awarded to Vitals Global Healthcare by Government: Part 1, A review of the tender process, The National Audit Office, https://content.maltatoday.com.mt/ui/files/nao_vgh_probe_addendum_concerning_mou.pdf.
6 State of Health in the EU, Malta, Country Health Profile 2019, World Health Organization.
7 SL 464.17, paragraph 7(a).
8 SL 464.17, paragraph 4(f).
9 SL 464.17, paragraph 8.
10 AnthiaZammit Legal was engaged by the Medicines Authority, Malta's national competent authority, to draft the General Guidelines on the Production of Cannabis for Medicinal and Research Purposes: http://www.medicinesauthority.gov.mt/file.aspx?f=4137, the Production for Cannabis for Medicinal and Research Purposes (Fees) Regulations 2018: http://justiceservices.gov.mt/DownloadDocument. aspx?app=lp&itemid=29382&l=1, and the Application for a Licence in accordance with the Production of Cannabis for Medicinal and Research Purposes Act: https://servizz.gov.mt/en/Pages/ Health-and-Community-Care/Health/Medicines/WEB2427/default.aspx and the respective memos addressed to the Cabinet of Malta, the collective decision-making body of the government of Malta. The agricultural science and scientific EUGMP section (Appendix 1) of the General Guidelines was written by Professor Everaldo Attard.