The Healthcare Law Review: Malta

Overview

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).

Outpatient medical care coverage is below 60 per cent in Malta. On average across EU countries, around one‐fifth of all health spending is paid out-of-pocket by households, but this proportion exceeds more than one‐third in Malta and some other EU countries.3

The private market

The private market 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 or administered by a private hospital on an in-patient basis) 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. The Maltese Health Ministry advises foreign residents to take out private medical insurance.

In order to be eligible to file an application to acquire Maltese citizenship by naturalisation for exceptional services by direct investment, the criteria established by the Granting of Citizenship for Exceptional Services Regulations (SL 188.06) must be satisfied.4

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.

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. Other private hospitals and clinics also operate in Malta.

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:

(1) The Minister may refuse to issue or renew, or may withdraw a licence in respect of a clinic if he is satisfied -
(a) 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
(b) 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
(c) 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
(d) 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
(e) that the arrangements for the management and control of the services provided at the clinic are not adequate.

Appeals

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.

Licences

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:

  1. the Medical Council;
  2. the Pharmacy Council;
  3. the Council for Nurses and Midwives; and
  4. 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.5

Community pharmacists

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.

Pharmacy licence

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.6

Negligence liability

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 herself 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.7

In Lawrence and Grace Mercieca v. Director General of the Department of Health et the First Hall Civil Court decided on 28 February 2019 that a doctor's duty is to provide sufficient information according to 'generally accepted medical practice' and is not obliged to advise and provide all the information to patients to allow them to make an informed decision about any surgery or treatment they might take. Divergences in doctors' opinions would not necessarily result in a court's finding of negligence. In this case, the court found that the neurosurgeon had failed to exercise the required medical standard of care. The court found the neurosurgeon and his employer, the Director General of the Department of Health, to be responsible for damages and awarded the plaintiff €123,383.18.

The Court of Appeal ruled that according to Maltese law, the relationship between a doctor and a patient, whether in private practice or the public sector, is a contractual relationship. The plaintiff must prove causation between the medical incident and the disability caused. The doctor must prove that the medical procedure was carried out with the necessary skill and diligence of the best medical practices. On 28 June 2019, in the case of Vincent and Mary Gauci v. Government Chief Medical Officer and Dr Albert Fenech, the Court of Appeal condemned the defendants to pay a sum of €41,732.35 after the plaintiff had undergone an angioplasty that left him unable to walk without crutches, suffering a 33 per cent disability. The Court based this judgment on laws and case law such as the case of Savona noe v. Asphar, which established that all medical professionals must act in accordance with the prudence, diligence and attention of a bonus paterfamilias. The Court of Appeal declared that although doctors cannot guarantee a specific result, they have an obligation to ensure that the physical health condition of the patient is not worsened. The plaintiff proved that as a result of nerve damage caused by the surgery he could no longer walk unassisted. The doctor is then obliged to prove the procedure was carried out diligently. The Court of Appeal considered this a case of medical negligence, and confirmed the judgment of the First Court. The Court held that since the relationship between the two parties was contractual, the Chief Medical Officer, as the doctor's employer, was also responsible and awarded damages to the plaintiff amounting to €41,732.35.

Ownership of healthcare businesses

i Public–private partnership

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. 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 its reports were published on 7 July 2020.8

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.9 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'.

In April 2021, the National Audit Office published its report 'The contract awarded to the JCL and MHC Consortium by the St Vincent de Paul Residence for the management of four residential blocks through a negotiated procedure'. The NAO reports are published in accordance with the First Schedule of the Auditor General and National Audit Office Act 1997 and are presented to the House of Representatives.

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.10 Conducting commercial enterprise of medicines can result in the doctor's erasure from professional registers.11 SL 464.17 stipulates that doctors ensure their professional independence and must not accept conditions that could jeopardise it.12

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.

Coronavirus

Malta has reported a total of 423 deaths resulting from covid-19 infections to date. Malta joined the Inclusive Vaccine Alliance and has fully vaccinated 373,771 people against covid-19 to date.13 As an EU Member State, Malta signed up to the EU vaccine passport system on 1 July 2021. On 14 July 2021, Legal Notice 300 and 301 of 2021 were published, requiring all people arriving in Malta to quarantine for 14 days in a 'quarantine hotel' specifically designated by the Maltese government, unless they had received the full dose of one of the four covid-19 vaccines that were granted a conditional marketing authorisation by the European Medicines Agency 14 days prior to arrival. (Maltese residents must be granted the Superintendent of Public Health's permission to quarantine in their own residence.) Arrivals must present a completed public health travel declaration and passenger locator form (PLF) or the digital PLF. Allowing travel only on the basis of vaccination or 14-day quarantine is a departure from the EU vaccine passport system that allows people to travel in the EU on the basis of vaccination, prior infection or a negative polymerase chain reaction (PCR) test result. The Malta Licensing Authority did not grant national emergency authorisation to covid-19 vaccinations and relied on the final assessments made by the European Medicines Agency (EMA). Malta rolled out its national covid-19 vaccination programme through its national health service, offering the four covid-19 vaccines granted a conditional marketing authorisation by the EMA. Malta's hospital capacity was already stretched in 2018.14 Covid-19 brought with it fears that the public healthcare system would not be able to cope under increased pressure.15

Regulations introduced by the Maltese government and promulgated into law have included the following non-pharmaceutical measures: mask mandates (the use of masks indoors and outdoors), mandatory closure of businesses considered 'non-essential', as well as closure of workplaces, schools and higher education institutions, the prohibition of social gatherings, a limit on the number of people who can meet and congregate in public and in private residences, the cancellation of sport and cultural events, the suspension of religious services, restrictions on social interactions, physical distancing measures and police patrols on the streets. People who test positive after taking a polymerase chain reaction (PCR) test are subject to a mandatory stay-at-home order, requiring them to remain isolated in their residence on penalty of high fines.16

Important legal and policy concerns and challenges have emerged, including those involving human rights, privacy and the protection of sensitive data, and social and economic impact. There appear to be gaps and even conflicts between national and international law in response to the pandemic. Countries have enacted many emergency laws and administrative acts. There are divergences between constitutional law, human rights and sovereignty, and global health security and governance. Can international law address and limit the use of extraordinary government powers invoked in the name of public health, which may have been abused during the covid-19 pandemic at a huge economic and social cost to citizens? In November 2021, a special session of the World Health Assembly will convene to discuss a potential international instrument on pandemic preparedness and response.17 Decision-making by supranational authorities on a global level could also be seen to pose a challenge to sovereignty in matters of public health and healthcare management. Covid-19 presents legislators and jurists with largely unchartered, potentially perilous, territory.

Future outlook and new opportunities

i Medicine pricing: the Valletta Group

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. There may be difficulties in determining whether new medicines should be fast-tracked through the exceptional route or added to the regular entitlement package.

Conclusions

i 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. Many 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.18

ii Bilateral and multilateral relations in healthcare and pharmaceutical cooperation

Medicine procurement is expected to be revolutionised by EU joint procurement and enhanced global cooperation in the sale, supply, and distribution of medicinal products and vaccines.19 The COVID-19 Tools Accelerator and COVAX Facility aim to make 2 billion vaccine doses available worldwide by late 2021. A joint US–EU covid-19 manufacturing and supply chain taskforce has been established to enhance cooperation and expand vaccine and therapeutics production capacity, including by building new production facilities, maintaining open and secure supply chains, avoiding any unnecessary export restrictions, and encouraging voluntary sharing of know-how and technology on mutually determined terms, including through the ACT-A. There are plans for a more global approach via the Independent Panel for Pandemic Preparedness and Response (IPPPR) recommendation towards a Global Health Threats Council.20

With respect to clinical trials, 'Member States are encouraged to implement the harmonised guidance to the maximum possible extent to mitigate and slow down the disruption of clinical research in Europe during the public health crisis. At the same time, sponsors and investigators need to take into account that national legislation and derogations cannot be superseded.21 The EMA guidance on the management of clinical trials during the covid-19 pandemic includes changes to informed consent.

Regarding the start of new trials aiming to test new treatments for covid-19, the EU 'Member States support the submission of large, multinational trial protocols for the investigation of new treatments for COVID-19'.22

Footnotes

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 OECD/European Union (2020), Health at a Glance: Europe 2020: State of Health in the EU Cycle, OECD Publishing, Paris, https://doi.org/10.1787/82129230-en.

4 The Regulations prescribe the requirements and regulate the granting of citizenship by naturalisation for exceptional services to Malta on the basis of humanity or exceptional interest to Malta, in accordance with Section 10(9) of the Maltese Citizenship Act. According to Section 6(1)(c) an application for naturalisation as a citizen of Malta can be disqualified if the applicant or any of the applicant's dependants is 'an actual or potential threat to national security, public policy, or public health of Malta'. Section 8(2) states the forms for the eligibility assessment shall be accompanied by the originals or certified copies of documents, including 'a declaration on the form issued by the Agency,4 duly filled and certified by a recognised medical practitioner, clinic, hospital, medical or health institute or other health care system attesting that the applicant and his dependants are in good health and are not suffering from any contagious disease and are not likely to become a burden on the Maltese public health system.' The regulations also state that any other document 'may be required by the Agency from time to time'.

5 Health, Bioethics, and the Law, Cauchi, Aquilina, Ellul, Malta University Press, 2006.

6 The legal and regulatory framework for community pharmacies in the WHO European Region, World Health Organization.

7 'The Doctor and the Law', Anthia A Zammit, Scripta Manet (European Law Students Association, Malta) (2007).

8 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.

9 State of Health in the EU, Malta, Country Health Profile 2019, World Health Organization.

10 SL 464.17, paragraph 7(a).

11 SL 464.17, paragraph 4(f).

12 SL 464.17, paragraph 8.

14 'Bed occupancy rates provide complementary information to analyse hospital capacity, with (in the current context) high occupancy rates symptomatic of a health system with limited capacity to handle unexpected surges in patients requiring hospitalisation. In 2018, bed occupancy rates for curative (acute) care averaged 73% across EU Member States. However, they were 91% in Ireland, and just over 80% in Portugal, Belgium and Malta'. See footnote 3.

18 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.

19 Roel Beetsma, Brian Burgoon, Francesco Nicoli, Anniek de Ruijter, Frank Vandenbroucke, 'Public support for European cooperation in the procurement, stockpiling and distribution of medicines', European Journal of Public Health, Volume 31, Issue 2, April 2021, Pages 253–258, https://doi.org/10.1093/eurpub/ckaa201.

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