The Life Sciences Law Review: Malta
Malta has the second largest pharmaceutical trade balance per capita in the European Union (€614 million in 2016), the tenth in total, and was the EU's fastest growing pharmaceutical exporter between 2001 and 2016 with an unprecedented increase of 45 per cent.2 The export of generic pharmaceuticals in 2017 exports exceeded €288 million. Malta's Gross Domestic Product in 2017 amounted to €11.1 billion. The Malta Freeport, operated by CMA-CGM, is the third largest in the Mediterranean and handles over 3.1 million TEUs (twenty-foot equivalent units) each year.3 The unprecedented government lockdowns following the covid-19 pandemic led to significant global supply chain disruption. Changes and challenges to the supply chain are compounded by Brexit, the European Commission's Mobility Package (a collection of three initiatives concerning the governance of commercial road transport in the EU), and the European Commission's 2030 Climate Target Plan. More than 30 established international pharmaceutical brand names operate in Malta, including several US mega-cap corporations. The Malta Enterprise Act (Chapter 463 of the Laws of Malta) established a corporation (Malta Enterprise) to promote and support foreign direct trade and investment, to encourage the incorporation of new business, and the expansion of existing business in Malta.
In 2020, Aurobindo invested in oncology R&D and set up a highly specialised new oncology laboratory in Malta to test oncology medicines destined for the EU markets. Aurobindo is among the top 10 generic companies in seven out of 11 countries in Europe. Since its inception in Malta in 2008, the operations and facilities in Malta play a strategic and important role in Aurobindo's EU distribution network. Aurobindo Malta's advanced analytical testing facilities handle in excess of 1,000 batches per month of sterile and non-sterile products, including separate dedicated facilities geared-up to test 4,000 batches of high-potency products per annum. Aurobindo employs 175 personnel in Malta. Since 2021, the Quality Director of Aurobindo Europe is based in Malta.4 In 2022 the US$3.0 billion Torrent group, one of the leading multinational pharmaceutical companies from India, will build significant investment in Malta. Torrent is one of the industry leaders in cardiovascular and CNS therapeutic segments with significant presence in diabetes, gastrointestinal and pain management, and is spearheading its presence in oncology, dermatology, gynaecology, nephrology and rheumatology.5
Companies must adhere to EU requirements in manufacturing, licensing and distribution of pharmaceuticals, active pharmaceutical ingredients and medical devices, and several companies also receive US Food and Drug Administration accreditation.
This chapter summarises the Maltese laws governing medicines and medical devices. Malta is the EU's smallest Member State and has implemented the EU medicines and medical devices regimes. We will therefore not repeat the substantive content of the EU chapter, but will only focus on unique, different and significant features of the Maltese regime. This chapter should be read in conjunction with the EU chapter.
The principal regulatory authority to ensure the quality, safety and efficacy of medicines is the Superintendent of Public Health, which is the licensing authority for the purposes of the Medicines Act.6 The Medicines Authority is a body corporate having a separate and distinct legal personality and its functions are delegated to it by the Licensing Authority. It is responsible for assisting and advising the Licensing Authority on any matter relating to the regulation of medicinal products and related activities, as well as establishing licensing and marketing procedures.
The Medicines Authority is headed by a Chief Executive Officer who must be qualified and experienced in the medical, pharmaceutical or medical science sector and who is appointed by the Minister responsible for public health. The Chief Executive Officer is responsible for the overall management and performance of the Medicines Authority including the management of its day-to-day operations. The Medicines Authority has established five directorates and appoints its own officers and employees. The terms and conditions of employment are set by the Medicines Authority with the 'concurrence' of the Minister responsible for public health, given after consultation with the Minister responsible for finance.7 Since at least 2019, the Medicines Authority does not receive a government subsidy as its budget is funded exclusively from 'user fees' imposed on the industries it regulates, mainly the pharmaceutical industry. User fees may include registration fees for marketing authorisation applications, annual licensing fees for manufacturing and wholesale dealing facilities, and marketed medicinal products. At the end of 2021, the Medicines Authority employed 93 personnel. In 2021, the Medicines Authority published its 'Strategy to 2025' document outlining its planned contribution to implement the European Commission (EC) Pharmaceutical Strategy, the European Medicines Agency (EMA), and Heads of Medicines Agencies (HMA) work programmes, arising from the Joint HMA-EMA network strategy to 2025. The Strategy sets out enhanced cooperation between national authorities on pricing, payment and procurement policies, with the aim of improving the affordability and cost-effectiveness of medicines.8
In Malta, medical devices and in vitro diagnostic medical devices are presently regulated and authorised by the Medicines Authority. The regulatory competence was transferred from the Malta Competition and Consumer Affairs Authority (MCCAA) to the Medicines Authority in 2020. Both the MCCAA and the Medicines Authority fall under the portfolio of the Parliamentary Secretary for Consumer Protection and Public Cleansing within the Ministry for Tourism and Consumer Protection. This legislative basis of the transfer of regulatory powers is Act VII of 2020 amending the Medicines Act (Chapter 458 of the Laws of Malta) and its subsidiary Legal Notices 318–321 of 2020 amending the subsidiary legislation.
'Medicinal products' are defined and regulated by the Medicines Act (Chapter 458 of the Laws of Malta) and its subsidiary legislation.9 Medical devices are regulated by the Medicines Act (Chapter 458 of the Laws of Malta), the Active Implantable Medical Devices Regulations (SL 427.10 of the Laws of Malta), the In Vitro Diagnostic Medical Devices Regulations (SL 427.16 of the Laws of Malta) and the Medical Devices Regulations (SL 427.44 of the Laws of Malta).
The In Vitro Diagnostic Medical Device Regulation (IVD Regulation) entered into force in May 2017 and will apply on 26 May 2022 with a progressive rollout.10 The IVD Regulation was adopted together with the Medical Devices Regulation (MDR) that has been applicable since 26 May 2021. The In Vitro Diagnostic Medical Devices Regulation (EU) 2017/746 (IVDR) establishes a new regulatory framework for in vitro diagnostic medical devices, such as HIV tests, pregnancy tests or SARS-CoV-2 tests. The IVDR will replace the current Directive 98/79/EC on in vitro diagnostic medical devices. For higher risk devices, such as HIV or hepatitis tests (class D), the new requirements will apply as from May 2025. For devices of the lower risk class C, such as certain influenza tests, the date of application is extended until May 2026, while for lower risk class devices (class B and A sterile), application starts in May 2027. The MDR and IVDR represent a significant development and change to the existing regulatory system for medical devices in Europe and replace the original Directives, which have been in place for over 20 years.
The Chamber of Commerce, Enterprise and Industry, based in Valletta, represents the pharmaceutical industry in Malta through three sections, namely: the Healthcare Business Section, the Professional Community Lead Pharmacists Business Section and the Pharmaceutical Manufacturers Business Section. The pharmaceutical manufacturers established their stakeholder group in 2003, before Malta's EU accession, to lobby their interests during the transposition of EU legislation. The pharmaceutical industry has evolved considerably to date as Malta was able to leverage foreign investment, especially with English being an official language, and developed a strong reputation in manufacturing, batch-release to the EU market, day-one product launches, good engineering expertise, and favourable economic growth. The Chamber of Commerce members now include active pharmaceutical ingredient (API) manufacturers, finished dosage form manufacturers, repackaging and labelling companies, wholesale dealers, brokers and pharmacists.
The regulatory regime
The Medicines Authority's Borderline Classification Committee distinguishes between medicinal and non-medicinal products.11 Assessments are made on a case-by-case basis. The Medicines Authority has issued borderline product classification guidelines and application forms. The guidelines explain the information and materials that must be provided for the classification to be undertaken, including dosage form, container type and packaging.12 The Borderline Classification Committee takes into account the medicinal claims made, intended use, mode of action, pharmacological properties and similar authorised medicinal products that are on the market.
Medical devices are classified according to the degree of risk the patient is exposed to. Malta's medical devices regulations establish standards to classify a medical device, centred on the level of invasiveness, mode of action, contact duration and impact on the patient. Active implantable devices are generally classified as high-risk medical devices, and the risk of in vitro diagnostic (IVD) medical devices is decided on the basis of use.
ii Non-clinical studies
The Good Laboratory Practice Regulations (SL 427.56) state that non-clinical studies must be carried out in conformity with the good laboratory practice (GLP) established by EC Directive 2004/10. The transposed regulations state that the inspection and verification of processes and conditions under which laboratory studies are planned, performed, recorded and reported for non-clinical testing shall be carried out in accordance with the rules and regulations, with respect to all chemicals (e.g., cosmetics, industrial chemicals, medicinal products, food additives, animal feed additives, pesticides) to assess the effect of such products on humans, animals and the environment.13
The National Accreditation Body – Malta Standards Authority (NAB-MSA) is the competent authority responsible for verifying compliance with the principles of GLP of any testing laboratory in Malta claiming to use GLP.14
The Animal Welfare Act (Chapter 439 of the Laws of Malta) establishes a Council for Animal Welfare comprising a chairperson and 11 members who advise the Minister responsible for veterinary services on all matters related to biotechnology in animals and animal experiments, and advise on the issuance of licences under the Animal Welfare Act. The Council, with the concurrence of the Minister, can also establish subcommittees for this purpose.
A licence issued by the Minister, acting on the advice of the Council, in conjunction with the Director for Veterinary Services is required to carry out animal experiments.15 The licence specifies the practice for which it is required and may include conditions and restrictions. Animal experiments must be authorised by the Council, may only be performed by competent authorised persons, or under the direct responsibility of such a person, and only if the experimental or other scientific project concerned is authorised in accordance with the provisions of the Animal Welfare Act to protect animal welfare.
The Good Clinical Practice and Requirements for Manufacturing or Import Authorisation of Investigational Medicinal Products (Human Use) Regulations (SL 458.47) state that available non-clinical and clinical information on an investigational medicinal product shall be adequate to support the proposed clinical trial.16
iii Clinical trials
The Clinical Trials Regulation (EU pharmaceutical legislation) entered into application on 31 January 2022. The Regulation governs large-scale clinical research and harmonises the processes for assessment and supervision of clinical trials throughout the EU. On 31 January 2022, the Regulation repealed the Clinical Trials Directive (EC) No. 2001/20/EC and national implementing legislation in the EU Member States that regulated clinical trials in the EU until the Regulation's entry into application.
The evaluation, authorisation and supervision of clinical trials are the responsibilities of EU Member States and European Economic Area (EEA) countries. Prior to the Regulation, clinical trial sponsors had to submit clinical trial applications separately to national competent authorities and ethics committees in each country to gain regulatory approval to run a clinical trial. The Regulation enables sponsors to submit one online application via a single online platform known as the Clinical Trials Information System for approval to run a clinical trial in several European countries.17
iv Named-patient and compassionate use procedures
Unlicensed medicinal products
The Committee for Unlicensed Medicinal Products was established to permit the use of unlicensed medicines in Malta. The Pharmaceutical Unit within the Ministry for Health is responsible for the processing of individual requests for medicinal products by certified prescribers and for use in public and private hospitals.
The 'Guidelines for the supply of medicinal products for human use through processes which are not covered by the Medicines Act, 2003 and its subsidiary legislation (unlicensed medicinal products)' include application forms.18 The supply and use of unlicensed medicinal products is restricted to circumstances where the licensed product cannot be obtained or the patient is not in a position to obtain the product directly from abroad for personal use under a doctor's prescription (Annex 1 of the Guidelines).
'Unlicensed products' do not include products that are: undergoing clinical trials, approved for compassionate use under European Council Regulation 726/04; prepared in a pharmacy under prescription; prepared by division of authorised packs into smaller units in a pharmacy for dispensing to patients within the same pharmacy; reconstituted intravenous preparations and prepared in centralised intravenous additive services; or used outside the clinical indications of their marketing authorisation.
The request for the use of an unlicensed medicinal product must be submitted by a doctor or a dentist registered in Malta to the Superintendent of Public Health. The request must explain why a licensed product is not a suitable alternative and include a declaration that the prescriber takes direct personal responsibility for the use of the unlicensed product.
Requests on a named patient basis must include the patient's signature confirming that he or she is aware that the medicinal product is unlicensed. The absence of the patient's signature has to be justified.
Exceptional medicinal treatment
In March 2018, the Maltese legislature passed the Exceptional Medicinal Treatment (EMT) Committee Regulations (SL 528.08). These regulations 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.
v Pre-market clearance
Medicinal products are approved and authorised for commercial distribution in Malta through the legal supply chain as follows:
- marketing authorisation according to Article 20 of the Medicines Act (Chapter 458 of the Laws of Malta) and Legal Notice 387 of 2004 as amended;
- marketing authorisation by centralised procedure (Regulation 726/2004);
- parallel import licence according to Legal Notice 437/2004;
- authorisation on the ground of public health according to Article 4(2) of the Medicines Marketing Authorisation Regulations (Legal Notice 387 of 2004) in accordance with Article 126a of Directive 2001/83/EC of the European Parliament and of the Council of 6 November 2001 on the Community Code relating to medicinal products for human use, as amended by Directive 2004/27/EC of the European Parliament and of the Council of 31 March 2004; and
- Licensing Authority approval of medicine to be put on the market in exceptional cases, subject to such conditions as the Licensing Authority may attach to it (Article 20(1) of the Medicines Act, 2003) on the ground of public health.
In the past seven years, the Licensing Directorate of the Medicines Authority processed 4,400 licensing applications that were granted a marketing authorisation in Malta. By the end of 2020, there were 2,368 medicines in Malta licensed under the Article 126a procedure.19 The Medicines Authority has set eligibility criteria for an Article 126a application, stating that 'this procedure should in no way be considered as an easy way of circumventing the current procedures stipulated by the EU legislation'. However, Malta, because of its small market size and availability challenges, has proven itself to be the biggest user of the Article 126a marketing authorisation. From around 5,400 national authorisations (inclusive of parallel importation licences), more than one-third have been licensed through the Article 126a procedure. A total of 960 national marketing authorisations and licences for new products were issued in 2020. Since 2007, Malta has been a Reference Member State (RMS) or a rapporteur in European registration procedures and has contributed to the authorisation of 557 products. Malta led 40 RMS procedures in the last quarter of 2019 and in the year 2020 resulting in 53 new marketing authorisations for Malta and other EU countries. In 2020, for the first time, Malta carried out an assessment as RMS in the DCP on the legal basis of Article 8(3) of Directive 2001/83/EC. The number of MA applications in the MRP and DCP received in 2020 with Malta as EU Concerned Member State (CMS) resulted in 171 marketing authorisations.20
A study published by senior authorised officers of the Medicines Authority identifying pharmaceutical issues encountered during regulatory review in European marketing authorisation application procedures found that applicants would benefit from following published guidelines to avoid delays in the registration of medicines.21
EU laws apply for the licensing of biologics, biosimilars and generic medicines, and the validity of marketing authorisations. In the case of homeopathic and herbal medicines, the authorisation procedure is simplified and applications are received and reviewed by the Medicines Authority. The quality issues and regulatory challenges the pharmaceutical industry needs to consider when developing and producing biosimilars and in the submission of dossiers for marketing authorisations were studied and published by senior authorised officers of the Medicines Authority.22
The European Medical Device Regulation 2017/745 repealed the directives on medical devices: the European Medical Devices Directive 93/42 and the European Active Implantable Medical Device Directive 90/38. The Medical Device Regulation was published on 5 May 2017 and became applicable on 26 May 2021.23
The following national legislation applies to medical devices:
- the In Vitro Diagnostic Medical Devices (Amendment) Regulations (SL 427.16);
- the Active Implantable Medical Devices (Amendment) Regulations (SL 427.10);
- the Medical Devices Regulations (SL 427.44); and
- the Medical Devices and In-Vitro Diagnostic Medical Devices Provision on the Maltese Market Regulations (SL 458.59).
vi Regulatory incentives
Malta applies European pharmaceutical law, including data and market exclusivity, orphan medicines and paediatric medicines. The EU and the US in particular have adopted regulations, incentives and policies targeted at improving orphan drug access to patients suffering from rare diseases.24 Malta has no additional national regulatory requirements beyond the EU requirements.
The Medicines Act regulates the period of data exclusivity. The Medicines Act data protection and exclusivity provision arises from the derogation of Article 10 of European Council Directive 2004/27.
Generic medicines and Roche Bolar
Malta is one of the few EU Member States that has a broad interpretation of the Roche Bolar provision, which has been incorporated in the Maltese Patents and Designs Act, and fully recognises the research exemption of the Patent Cooperation Treaty and European Patent Convention, by which generic companies can undertake development, but not commercialisation, of drugs prior to patent expiry.25
The Medicines Authority recognises joint or multilingual labelling with other countries to be an incentive for retaining medicinal products on the Maltese market. The Medicines Authority has facilitated joint or multilingual labelling with the UK, Ireland and other markets, and continues to pursue collaboration opportunities with other European competent authorities for multilingual labelling.
Day zero mutual recognition procedure (simplified procedure)
To address medicines availability challenges in Malta, the Medicines Authority accepts the assessment of the RMS or the national competent authority (where the product had been authorised nationally), without any comments or questions. The approved product information will also be accepted without any comments. The Medicines Authority does not request any update of the assessment report or the dossier, nor are there any changes related to such procedure, except that in this simple way Malta joins a mutual recognition procedure (MRP). These procedures are finalised once the application has been accepted by the RMS and the Medicines Authority, known as an 'MRP day zero procedure'. Day zero licensing procedures have already been executed successfully with various RMS countries.
Article 126a authorisations
One-third of all medicine registrations in Malta are authorised through Article 126a. The Public Contracts Review Board (PCRB or the Board) decision of 18 February 2020 ushered in a reviewed and improved Article 126a marketing authorisation (MA) process that same year, starting on 1 October 2020.
The PCRB's Case 1412 regarding the Tender CT2340/2018 for the Supply of Human Biosynthetic Insulin Preparations for Injection in Cartridges decided on the objections against the Central Procurement and Supplies Unit (CPSU or Contracting Authority).
The appellants contested the safety and quality of gensulin, particularly because of the importance and wide use of insulin in Malta. The appellants claimed gensulin did not ensure patients' safety; and the product is not bio-equivalent to the original product but is bio-similar.
The Board ruled that:
- the chosen bidder's offer for the procurement of gensulin was the cheapest offer and complied with the technical specifications;
- the evaluation committee, comprising qualified professionals in pharmacology, carried out the evaluation process in a fair and transparent manner;
- the product gensulin is registered in Malta by the Medicines Authority through an Article 126a Marketing Authorisation, which allows a EU member state (Malta) to recognise a product registered in another EU member state (Poland);
- no negative results have been reported since the product's authorisation in Poland;
- the appellants did not present any evidence to demonstrate that gensulin did not satisfy the tender's technical specifications; and
- the appellants could have taken remedial action before submitting their tender offer by disputing the tender specifications.
From 1 October 2020, the new Article 126a application process asks the applicant to provide detailed public health justifications for choosing this route. The Medicines Authority now states that 'if a product is eligible to be authorised through the established legal routes for marketing authorisation, the Medicines Authority has the right to refuse the application under the Article 126(a) legal basis'. Applicants are asked to consider all other possible routes for registration, effectively leaving Article 126a as a last resort. Article 126a authorisations are now valid for three years, and validity can only be extended if the product has been procured by a government tender beyond the validity of the authorisation, to ensure that the public procurement obligation is fulfilled. The Medicines Authority has established an Advisory Committee with the purpose of discussing Article 126a applications. The Medicines Authority is expected to accept less Article 126a authorisations for each product on the market, with the effect of reducing the number of Article 126a authorisations.26
vii Post-approval controls
Pharmaceutical companies and regulatory authorities must honour their pharmacovigilance obligations according to EU law. The Medicines Act (Chapter 458 of the laws of Malta), and its subsidiary legislation namely the Pharmacovigilance Regulations SL 459.35, transpose the European Council Directive 2001/83 (as amended). The Medicines Authority has also published Guidance Notes for Pharmaceutical Companies on Pharmacovigilance Obligations and Adverse Drug Reaction (ADR) Reporting Requirements for Medicinal Products for Human Use (last amended in December 2019). There are no significant country-specific obligations provided for by Maltese law.
The Medicines Authority ensures patient safety by communicating with healthcare professionals, evaluating safety reports and conducting pharmacovigilance inspections to assess marketing authorisation holders' (MAH) compliance with pharmacovigilance obligations. MAHs must comply with their pharmacovigilance obligations to maintain the marketing authorisation of a medicines product.27
If there are concerns affecting the risk-benefit balance of an authorised medicinal product, the Medicines Authority may impose an obligation on a MAH to operate a risk management system and to submit a detailed description of the risk-management system that the MAH intends to introduce for the medicinal product concerned. The imposition of such obligations shall be duly justified, notified in writing and shall include the time frame for submission of the detailed description of the risk management system.28
Staffing requirements for MAHs – the QPPV
MAHs in Malta must appoint a qualified person for pharmacovigilance (QPPV). The MAH shall submit the name and contact details of the QPPV to the Medicines Authority and the European Medicines Agency. The Medicines Authority may request the nomination of a contact person for pharmacovigilance issues in Malta (at national level) who reports to the QP responsible for pharmacovigilance activities.
Variations and transfer of ownership of product approvals
Post-authorisation procedures are handled by the Medicines Authority and include variations, notifications, renewals and withdrawals. Variations of marketing authorisations are governed by European Variation Regulation 1234/2008, amended by European Regulation 712/2012, which introduced work-sharing of different types of procedures, timelines, and takes into account the new European pharmacovigilance regulations. European Council Directive 2009/53 applies to variations submitted for nationally authorised medicines. The transfer of ownership of the marketing authorisation is made by filing the relevant request forms to the Medicines Authority depending on whether the marketing authorisation has already been issued or not.
The Medical Devices Regulations impose post-market surveillance obligations. Medical devices that compromise the health and safety of patients may be withdrawn from the market or prohibited or restricted by the Director of Market Surveillance after interim measures are taken. The Market Surveillance Directorate may carry out inspections, including the technical documentation and the CE conformity declaration. The Medical Devices Regulations specify that regulatory data must be uploaded to the European databank and made accessible to the national competent authorities.
viii Manufacturing controls
The main applicable legal instruments are (1) the Manufacture and Importation of Medicinal Products for Human Use Regulations (SL 458.36); (2) the Good Manufacturing Practice in Respect of Medicinal and Investigational Medicinal Products for Human Use Regulations (SL 458.42); and (3) the Good Clinical Practice and Requirements for Manufacturing or Import Authorisation of Investigational Medicinal Products (Human Use) Regulations (SL 458.47).
The manufacture of any dosage form of a medicinal product must be in conformity with EU good manufacturing practice (GMP) throughout the entire manufacturing process until its release on the market. The applicant must hire qualified staff, particularly the qualified person (QP) responsible for manufacturing. The Medicines Authority Inspectorate and Enforcement Directorate carries out inspections to verify that the technical facilities and equipment is in place and that the manufacturing site fulfils all legal and EU GMP requirements.
The authorisation timeline is as follows: the application is vetted within 10 days of being submitted by the applicant; the assessment is then expected to take six months (unless further information or clarifications are needed); and the approval is issued within five days of conclusion of the assessment. The decision is then delivered within the following two days.
The list of licensed manufacturers is published on the Medicines Authority website.29
Inspections and enforcement
The Inspectorate and Enforcement Directorate of the Medicines Authority is responsible for carrying out inspections of wholesalers and manufacturers or importers, and issuing licences, licence renewals, and variations. The Directorate enforces the Medicines Act (Chapter 458 of the Laws of Malta) and its subsidiary legislation, EU GMP and EU good distribution practice (GDP). The Directorate regulates 70 licensed or certified entities, in Malta and in third countries, involved in the manufacturing, importation or other GMP-related activities of medicinal products for human use. In 2020 the Directorate carried out eight national GMP inspections including inspections for (1) cannabis for medicinal or research purposes; (2) full line non-sterile solid dosage manufacturers; (3) MAs for repackaging and re-labelling or partial manufacturing operations; (4) repackaging and re-labelling or partial manufacturing operations; and (5) import activities. The Directorate regulates 90 licensed or certified local entities involved in wholesale dealing and brokering activities of medicinal products for human use, and of active pharmaceutical ingredients distribution and importation. During 2020, the Directorate fulfilled its GDP inspection plan and carried out 25 GDP inspections. In regard to EU and third country inspections, the Directorate carried out only four EU GMP inspections in India in the first months of 2020 as third country GMP inspections were interrupted as a result of the covid-19 travel restrictions. Applications were validated to be processed, and inspections carried out when travel restrictions were lifted.30
The same national legal framework protecting the safety, efficacy and quality of medicines includes medical devices.
ix Advertising and promotion
The advertising of medicinal products is governed by the Medicinal Products (Advertising) Regulations (SL 458.32), which transpose European Directive 2004/27 into Maltese law and regulate advertising to the general public and to healthcare professionals. The Medicines Authority has also issued guidelines, last updated in February 2020. The system of medicines advertising is based on self-regulation as the Medicines Authority does not review advertising prior to its publication but offers guidance and monitors advertisements.
It is unlawful to advertise medicinal products that have not been granted marketing authorisation. No medicinal products may be distributed directly to the public by the industry for promotional purposes. There are exceptions to the advertising criteria/requirements with respect to vaccination campaigns carried out by industry after having obtained the approval of the Licensing Authority.31
Compliance orders issued by 'qualified entities' as defined by law, administrative penalties, and other administrative sanctions are made under the Medicines Products (Injunction to Advertising) Regulations (SL 458.51), which transpose European Directive 92/28 implementing it into Maltese law.
EU laws apply.
The Broadcasting Act (Chapter 350 of the Laws of Malta) includes rules on the broadcasting of medicinal products advertising. The Commercial Code (Chapter 13 of the Laws of Malta) applies to all advertising in Malta.
x Distributors and wholesalers
The applicable legal instrument is the Wholesale Distribution and Brokering of Medicinal Products and Active Substances Regulations (SL 458.37). These Regulations also apply to homeopathic medicinal products. The Medicines Act (Chapter 458 of the Laws of Malta) defines 'wholesale distribution'. The Medicines Authority publishes a list of licensed wholesale dealers in Malta, last updated in December 2019.32
The national competent authority (the Licensing Authority) shall grant the applicant a wholesale distribution licence (WDL) within 90 days of the date of receipt of the application provided the requirements listed in Article 8 of SL458.37 are met. This timeline is suspended if the applicant is asked to provide additional information. The application must also include the pharmaceutical forms of the medicinal products to be distributed, in particular whether they are sterile, require storage below 8ºC, details on whether they are narcotic or psychotropic substances, blood, immunological medicinal products or radiopharmaceuticals.
One of the requirements is that the applicant must engage a responsible person (RP). The RP is a registered pharmacist with the Malta Pharmacy Council and recognised as suitable by the national competent authority. The RP must be knowledgeable of proper conditions for the storage and distribution of medicinal products and have an understanding of GDP and must comply with the duties assigned to the RP as described in the Regulations. The RP can be a full-time employee, a part-time employee or work on a contract basis for the wholesale dealer. The Medicines Authority publishes a list of pharmacists accepted by the Medicines Authority to act as RPs.
Marketing authorisation holder letter of access
For each medicinal product distributed in Malta, the wholesale dealer must provide the Licensing Authority with an authenticated copy of the marketing authorisation together with a letter of access issued by the MAH granting the wholesale dealer the use of such marketing authorisation. The only exception is if the wholesale dealer is in possession of a valid parallel import licence.
Patients' needs and medicines supply obligations
The Regulations also require every wholesale dealer, within the limits of their responsibilities, to ensure that 'an appropriate and continuous supply of medicinal products is provided to pharmacies and persons authorised to supply medicinal products' to satisfy patients' needs.
Good distribution practice
The Licensing Authority requires full traceability of product quality throughout the entire supply chain and the wholesale dealer's conformity with the EU Good Distribution Practice (EU GDP) standards. The Medicines Authority carries out EU GDP inspections. The licensed entity is given a list of findings after the Medicines Authority inspection, which they are required to respond to with proposals for corrective action within 28 days. Once all findings have been addressed with a satisfactory corrective action plan and measures, the renewal of the wholesale dealer's licence is recommended to the Licensing Authority. Site re-inspection is performed at a frequency determined by the Medicines Authority by a systematic risk-based assessment.
The Medicines Act (Chapter 458 of the Laws of Malta) regulates the wholesale dealing of medical devices.
xi Classification of products
The Borderline Classification Committee classifies borderline products into medicinal or non-medicinal products in line with the EU pharmaceutical law definition of medicinal product.
In Malta, medicines can only be dispensed to a patient from a licensed pharmacy. Medicinal products are either prescription-only medicines (POM) (dispensed by a pharmacist to the patient under a physician's prescription) or over-the-counter products (OTC) (dispensed by a pharmacist to the patient without a prescription).
Classifying medicines as prescription-only or over-the-counter is part of the Marketing Authorisation process that licenses and ensures the quality, safety and efficacy of the medicinal product. The Medicines (Marketing Authorisation) Regulations (SL 458.34) specify the POM classification criteria. The Prescription and Dispensing Requirements Rules (SL 458.49) stipulate the content of the prescription and the dispensing regulations.
The Prescription Forms for Free Medicinals Rules (SL 458.24) govern the provision and prescription of medicinal products and medical aids to the patients at no cost to the end-user through the national health service (NHS) under the Social Security Act (Chapter 318 of the Laws of Malta).
Medical devices are classified in line with European law, on the basis of their risk to patients.
xii Imports and exports
Maltese legislation governing the import and export of medicinal products and medical devices generally reflects EU rules. Import regulations are enforced by the Customs Authority, and the Commissioner for Revenue also plays a part. Import tariff regulations are established by the Import Duties Act (Chapter 337 of the Laws of Malta). Product classification in Malta is made under the Harmonised Standard (the HS code number). The Dual-Use Items (Export Control) Regulations (SL 365.12) control dual-use export goods. European Council Regulation 428/2009, which governs the EU's export control regime, applies to Malta.
The main applicable legal instrument is the Manufacture and Importation of Medicinal Products for Human Use Regulations (SL 458.36). In Malta, an importer's licence (IL) is required for the importation of medicinal products.33 'Imported medicinal products' means medicinal products obtained from a source outside the EU or the EEA.34
All medicinal products for human use imported into Malta and the EU from a non-EU or non-EEA country, including medicinal products intended for export outside the EU and not intended for the Maltese market, are to be manufactured in accordance with the principles and guidelines of EU GMP.35 It is the importer's duty to ensure that medicinal products imported from third countries have been manufactured in accordance with standards equivalent to the EU GMP standards by authorised manufacturers.36
In Malta, any licence holder (whether the holder of a manufacturing or importation licence, a wholesale dealing licence) must be a natural person or a legal person. 'Licensee' means any person who is the holder of a licence for a particular activity granted under the Medicines Act.37 Whichever entity within the EU or EEA first physically receives medicinal products entering the EU or EEA market from a non-EU or non-EEA country must be in possession of an IL.
The IL is issued by the national competent authority following verification of the contents of the application, but no later than 90 days from the date of receipt of the application. This time period is suspended when additional information is requested from the applicant. The national competent authority may grant a conditional licence subject to the applicant's fulfilment of the legal requirements. The IL shall only apply to the premises, medicinal products and pharmaceutical forms specified in the application.38
There must be a QP approved by the Maltese national competent authority for batch release, who ensures that each batch complies with the law, the GMP, the importer's or manufacturer's authorisation and the marketing authorisation.39
The Wholesale Distribution and Brokering of Medicinal Products and Active Substances Regulations (SL 458.37) state that wholesale distributors of active substances must comply with EU GDP, including active substances intended for export.
The Licensing Authority is responsible for taking the necessary measures to prevent medicinal products that are brought to the EU, but are not intended to be placed on the EU market, from entering into circulation if there are sufficient grounds to suspect that those products are falsified. These measures include applying the SL 458.37 regulations to warehouses in the free trade zones and customs bonded warehouses used to store medicinal products.40 Licensed entities are obliged to implement the Falsified Medicines Directive (2011/62/EU) and the Delegated Regulation on Safety Features (2016/161).
The Falsified Medicines Directive (Directive 2011/62/EU) established the need for a safety feature that enables authenticity to be verified and to identify individual packs. The Delegate Regulation on Safety Features (2016/161) imposes the following measures:
- a requirement for medicine packs to carry special safety features in the form of an anti-tamper device (e.g., foil seal, breakable cap) and a two-dimensional barcode containing 'unique identifiers' (including a serial number) to enable the authenticity of the pack to be checked before dispensing; and
- a common, EU-wide logo to identify legal online medicines suppliers, making it easier to distinguish them from illegal operators.41
The Malta Medicines Verification Organization (MaMVO) was established in 2018 as a not-for-profit entity. The MaMVO is authorised to establish, administer, operate and monitor the Malta Medicines Verification System (MaMVS) to support all the licensed entities that are obliged to implement the Falsified Medicines Directive. The MaMVO's objective is to permit the verification of the authenticity of medicines dispensed in Malta throughout the pharmaceutical supply chain, and to permit the identification of potential incidents of falsification.42
The import and export of medical devices is regulated by the Medicines Act (Chapter 458 of the Laws of Malta) and by the applicable European regulations.
xiii Controlled substances
Malta ratified the Single Convention on Narcotic Drugs on 22 February 1990.43 The Single Convention has 186 state parties.
The importation, manufacture, exportation, purchasing and selling of any controlled drug is subject to the Drugs (Control) Regulations (SL 31.18). These activities need to be authorised by the Superintendent of Public Health and registered and reported to the Superintendent at specified time frames. Importation and exportation procedures including details to be submitted and labelling requirements are at the Superintendent's discretion. Dispensing controlled medicines must follow the applicable protocols.
According to the Medical and Kindred Professions Ordinance, the Health Minister, after consultation with the Council of Health, can amend, add to, revoke or substitute the list of psychotropic drugs. The Health Minister can also make regulations for controlling the manufacture, exportation, importation, possession, distribution and sale of psychotropic drugs, in the public interest.
The Licensing Authority has delegated its enforcement powers to the Medicines Authority. A dedicated Inspectorate and Enforcement Directorate within the Medicines Authority is tasked with enforcement and market surveillance. Article 101 and 101A of the Medicines Act (Chapter 458 of the Laws of Malta) establishes broad enforcement powers including right of entry, inspection, taking of samples, and seizure of goods and documents of any person duly authorised in writing by the national competent authority.
On production of his or her authorisation or credentials, such authorised person shall have a right to enter and carry out repeated and unannounced inspections at any premises (including any building, place or means of transport) at any reasonable time for the purposes of ascertaining whether there is, has been or is likely to be any breach of the provisions of the Medicines Act and its subsidiary legislation.
An authorised officer shall, on the production of his or her authorisation, have a right to board any ship or aircraft at any reasonable time to ensure that no substance or article is imported in contravention of the Medicines Act and its subsidiary legislation.
Offences and penalties
Article 99 of the Medicines Act establishes the penalties, in the form of fines and terms of imprisonment, in the event of conviction for failure to comply with any of the provisions of the Medicines Act or any regulations or rules made thereunder.
Pricing and reimbursement
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.45
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.46
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. A Maltese pharmaceutical expert, former Medicines Authority CEO Dr Patricia Vella Bonanno, spearheaded and significantly contributed to a paper that presents the consolidated views and considerations of policymakers, payers, pricing and reimbursement authorities, and academics on the original European Commission proposal.47
Administrative and judicial remedies
The matter of legal interest is of paramount importance in litigation and judicial remedies. In Malta, legal standing is apportioned based on legal interest (i.e., the test for being an interest party). Interest must be direct and personal, meaning that the right claimed or alleged should belong directly to the patrimony of a person. Interest has to be legal, meaning it must find a legal basis and be qualified as being based and founded on a legal principle or legal provision. Interest must be actual, meaning that the party must demonstrate some actual benefit from the proceedings. This need not be economic benefit, but it could be intangible such as reputation.
The Medicines Review Board hears appeals submitted by the applicant of a marketing authorisation on any recommendation of the Medicines Authority in relation to the safety, quality and efficacy of a medicinal product and to provide advice and make its recommendations to the Licensing Authority in this regard. An appeal may be filed with the Medicines Review Board within 14 days of receipt of a copy of the Medicines Authority's recommendations and findings. The timelines and stages of the process are established by the Medicines Act. The Medicines Review Board appoints the matter for public hearing within 30 days of the day of filing the appeal or review request and shall decide the matter as expeditiously as possible. It is possible to file a warrant of prohibitory injunction as an interim measure provided certain conditions are met. It is also possible to file other civil law proceedings on the basis of unlawful government action; for example, under the Administrative Justice Act (Chapter 490 of the Laws of Malta) or the judicial review of administrative action under Article 469A of the Code of Organisation and Civil Procedure (Chapter 12 of the Laws of Malta).
Financial relationships with prescribers and payers
The Medicinal Products (Advertising) Regulations (SL 458.32), which transpose European Council Directive 24/2007, lay down a regulatory framework for the promotion of medicinal products and gift provisions to healthcare professional (HCP) prescribers.
Gifts to HCPs must be inexpensive and related to the practice of medicine or pharmacy. Hosting HCPs is restricted to events organised around a scientific theme and the same invitation should not be extended to non-HCPs. The provision of free samples to medical prescribers needs to be documented and is conditional to a number of provisos, such as having to be in their smallest presentation on the market and prohibiting the prescriber from using the free samples in any commercial transactions.
According to the Ethics of the Medical Profession Regulations (SL 464.17), practitioners cannot publicly endorse any particular commercial product or service.48 Moreover, conducting commercial enterprise of medicines can result in erasure from professional registers.49 SL 464.17 stipulates that doctors ensure their professional independence and must not accept conditions that could jeopardise it.50
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 HCP Code of Practice.
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).
Special liability or compensation systems
The European Council Product Liability Directive was transposed into Maltese law by introducing the principle of strict liability to the Consumer Affairs Act (Chapter 378 of the Laws of Malta), enabling consumers to claim compensation when a product causes death, personal injury, loss, damage or destruction of any item of property. The producer is also able to raise defences under the provisions of the Act.51 Under Maltese law, liability may arise either in contract or in tort. Private actions for damages suffered as a result of a breach of competition law would usually be founded on tort. Tort is based on fault. The Maltese Civil Code (Chapter 16 of the Laws of Malta) states that every person shall be liable for the damage that occurs through his or her fault.52 A person shall be deemed to be at fault if in his or her own acts he or she does not use prudence, diligence and attention of a bonus paterfamilias.53 Any person who, with or without intent to injure, voluntarily or through negligence, imprudence or want of attention, is guilty of an act or omission constituting a breach of duty imposed by law, shall be liable for any resulting damage.54
Transactional and competition issues
i Competition law
The Competition Act (Chapter 379 of the Laws of Malta) governs competition law in Malta. As an EU Member State, Malta subscribes to the EU competition law regime. National antitrust or competition law litigation in Malta of special relevance to the life sciences sector in Malta is not commonplace.
ii Transactional issues
Transactional issues in the pharmaceutical and medical device sectors, including mergers and acquisitions, joint ventures and licensing and strategic collaborations, inevitably have a regulatory impact, especially in the transfer of marketing authorisations and meeting pharmacovigilance requirements. The complex interplay of provisions of Maltese codified legislation, including but not limited to the the Medicines Act, the Commercial Code, the Civil Code, the Companies Act, the Competition Act, the Data Protection Act, the Patents and Designs Act, the Trademarks Act and the Copyright Act, would feature prominently in any transaction.
Since 1 February 2020, the United Kingdom has withdrawn from the EU and has become a 'third country'. As a small island EU Member State, Malta has experienced medicines access and availability challenges in its national healthcare service.55 Malta's national market is also expected to be affected by Brexit.56 The Medicines Authority has also seen a recent surge in applications to act as the RMS in medicines authorisation applications, partly because of the UK's impending exit from the EU as Malta takes over as RMS in applications where it is the only CMS. In 2019, MAH transfers were processed by the Medicines Authority as companies made arrangements to relocate from the UK and 455 product authorisations were withdrawn. By the end of 2019, 104 RMS procedures were transferred from the UK to Malta.
On 29 December 2021, the European Commission published an updated Notice: Application of the Union's Pharmaceutical Acquis in Markets Historically Dependent on Medicines Supply from or through Parts of the United Kingdom other than Northern Ireland. The Commission Notice permits temporary exemptions in case of justified need until the end of 2022. Until further information is made available on the implementation of the Notice, any exemptions from the requirement of batch release and batch testing from being carried out in the EU/EEA granted in 2021 will be automatically extended until further notice.
Under certain circumstances, Malta will be able to authorise the placing on the national market of a medicine authorised in the UK. On public health grounds, in the case of products for which there are no alternatives and that are required by patients, an authorisation for a UK product on the basis of the Commission Notice may be considered with Article 126(a) as legal basis, after discussion with the Advisory Committee. Authorisations on the basis of UK MAs that are currently invalid can be re-validated in case of need only (e.g., in the case of public tender where there are no alternative bidders or where there are availability issues). Invalid licences will not be automatically re-validated.57
On 13 October 2021, the non-paper on medicines regarding the Protocol on Ireland/Northern Ireland was published to address the adaptation of supply chains to the new situation created by the UK's withdrawal from the EU and the application of the Protocol on Ireland/Northern Ireland ('the Protocol') and the remaining challenging in the pharmaceutical sector, in particular for suppliers of generics and OTC medicines covered by national authorisations issued by the UK in respect of Northern Ireland.58
As of 1 January 2021, marketing authorisations in accordance with Article 126(a) and parallel import licences granted to Article 126(a) authorisations and parallel importers in the United Kingdom are no longer valid in Malta. Parallel import licences granted on the basis of products authorised in the UK are no longer valid irrespective of the country of the parallel import licence holder.
ii EU–US FDA mutual recognition of inspections of medicines manufacturers
On 1 November 2017, Malta became one of the first of eight EU Member States to begin mutual recognition of inspections of manufacturing sites for human medicines between the United States and the EU.
iii Medical cannabis
The Production of Cannabis for Medicinal and Research Purposes Act (Chapter 578 of the Laws of Malta) and its subsidiary legislation were enacted in 2018, legalising the production of cannabis for medicinal and research purposes. This initiative was led by the Medicines Authority's Advanced Scientific Initiatives Directorate.59
Licensed medical practitioners are able to prescribe cannabis-based medicinal products with a valid marketing authorisation, and other cannabis products for medicinal use that are manufactured under EU GMP. The Medicines Authority reviews applications for the importation or wholesale distribution of such products. The first licence was granted by the Medicines Authority in 2020.
The Inspectorate and Enforcement Directorate of the Medicines Authority carries out medical cannabis GMP inspections of the finished product to be placed on the Maltese market, and product that is manufactured in Malta or imported to Malta for further processing and export.
iv Medicines 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.
v The Pharmaceutical Strategy for Europe
Adopted on 25 November 2020, the Pharmaceutical Strategy will bring significant change to the regulatory framework to enhance support to the industry in promoting research and technologies to fulfil therapeutic needs and address market challenges. It will also take into account the weaknesses exposed by the coronavirus pandemic. The strategy is based on four pillars, which include legislative and non-legislative action:
- ensuring access to affordable medicines for patients, and addressing unmet medical needs (e.g., antimicrobial resistance and rare diseases);
- supporting competitiveness, innovation and sustainability of the EU's pharmaceutical industry and the development of high quality, safe, effective and 'greener' medicines;
- enhancing crisis preparedness and response mechanisms, diversified and secure supply chains to address medicines shortages; and
- ensuring a strong EU voice in the world, by promoting a high level of quality, efficacy and safety standards.60
vi Covid-19 vaccine
The European Commission granted a conditional marketing authorisation for the m-RNA vaccine Comirnaty developed by Pfizer and BioNTech on 21 December 2020 and Moderna's covid-19 m-RNA vaccine on 6 January 2021. On 29 January 2021, the EMA recommended granting a conditional marketing authorisation for covid-19 vaccine AstraZeneca.61 On 20 December 2021, the EMA recommended granting a conditional marketing authorisation for Novavax's covid-19 vaccine Nuvaxovid (also known as NVX-CoV2373) to prevent covid-19 in people from 18 years of age. Nuvaxovid, a protein-based vaccine, is the fifth vaccine recommended in the EU for preventing covid-19.62
Vaccine development and authorisation in the EU launched an ambitious and coordinated plan by EU Member States that sets the stage for a potential revolution in medicines procurement. Malta had encouraged the European Commission to prepare all the groundwork to launch a joint procurement process to purchase a covid-19 vaccine as soon as the vaccine is authorised.63 Malta participated in the EU joint procurement of the vaccine and is rolling out its national covid-19 vaccination programme through its national health service.64 In May 2021 it was reported that Malta had spent close to €100 million on covid-19 with most of this cost subsidised by the EU, and that Malta purchased vaccine doses for 2022 and 2023.65
Malta did not grant national emergency authorisation of covid-19 vaccinations. Malta relies on the final assessments made by the EMA.
vii European regulatory expectations and medicines shortages during the covid-19 pandemic
The European Commission, the EMA, and the national competent authorities have agreed on measures to mitigate the impact of disruptions caused by covid-19 on the conduct of inspections of manufacturing facilities or other sites relevant for medicinal products in the EU. For sites in and outside the EEA, GMP certificates and time-limited manufacturing and import authorisations are automatically extended until the end of 2022. This does not waive manufacturers' and importers' obligations to comply with GMP standards. If needed, inspections will be carried out remotely to support such extensions, with on-site inspections carried out as soon as feasible.66
Article 81 of Directive 2001/83/EC, 'The holder of a marketing authorisation for a medicinal product and the distributors of the said medicinal product actually placed on the market in a Member State shall, within the limits of their responsibilities, ensure appropriate and continued supplies of that medicinal product to pharmacies and persons authorised to supply medicinal products so that the needs of patients in the Member State in question are covered. The arrangements for implementing this Article should, moreover, be justified on grounds of public health protection and be proportionate in relation to the objective of such protection, in compliance with the Treaty rules, particularly those concerning the free movement of goods and competition'. Therefore, marketing authorisation holders are responsible for the continued supply of medicinal products. The EU Executive Steering Group on Shortages of Medicines Caused by Major Events published a reflection paper in June 2021 to provide a set of recommendations that can support demand forecasting at national level.67
1 Anthia A Zammit is an advocate at AnthiaZammit Legal.
2 Malta Pharma Exports and Trade Snapshot, Pharma Boardroom, 11 July 2018 (accessible at https://pharmaboardroom.com/facts/malta-pharma-exports-and-trade-snapshot/).
3 The Life Sciences Sector in Malta: An Overview, Malta Enterprise (accessible at www.maltaenterprise.com/sites/default/files/The%20Life%20Sciences%20Sector%20in%20Malta.pdf).
4 Aurobindo Pharma Investor Presentation, September 2021 (accessible at https://www.aurobindo.com/wp-content/uploads/2021/09/Aurobindo_Pharma_Investor_Presentation_INR_September_2021.pdf).
6 The Medicines Act (Chapter 458 of the Laws of Malta), Article 3.
7 The Medicines Act (Chapter 458 of the Laws of Malta), Articles 4–8. Professor Anthony Serracino Inglott has served as Chief Executive Officer of the Medicines Authority since 2013.
9 'Medicinal product' means any substance or combination of substances (1) presented as having properties for treating or preventing disease in human beings; or (2) which may be used in or administered to human beings either with a view to restoring, correcting or modifying physiological functions by exerting a pharmacological, immunological or metabolic action, or to making a medical diagnosis.
10 Progressive roll-out of the In Vitro Diagnostic Medical Devices Regulation, press release, https://ec.europa.eu/commission/presscorner/detail/en/ip_21_6965.
11 The Medicines Authority Terms of Reference state that the Borderline Classification Committee is composed of the Licensing Director who chairs the group; a quorum of six members representing the Licensing Directorate, the Inspectorate and Enforcement Directorate and the Advertising Committee; a member of the Committee on Herbal Medicinal Products and Homeopathic Medicinal Products Working Party; a physician (when necessary); and a secretary, to take minutes, list actions taken and to manage the administrative duties of the committee.
12 The Medicines Authority has issued guidelines on what constitutes a medicinal product, which appears on the Authority's website at www.medicinesauthority.gov.mt/classificationborderlineproducts.
13 Good Laboratory Practice Regulations (SL 427.56) Article 5.
14 Good Laboratory Practice Regulations (SL 427.56) Article 3.
15 Animal Welfare Act (Chapter 439 of the Laws of Malta) Article 32.
16 The Clinical Trial Regulations (SL 458.43) define an 'investigational medicinal product' to be 'a pharmaceutical form of an active substance or placebo being tested or used as a reference in a clinical trial, including products already with a marketing authorisation but used or assembled (formulated or packaged) in a way different from the authorised form, or when used for an unauthorised indication, or when used to gain further information about the authorised form'.
18 Form I: request for the use of an unlicensed medicinal product on a named patient basis, for a specific patient (applies to both the government health services and the private sector); Form II: request for the use of an unlicensed medicinal product by a hospital department within the government health services; Form III: request for the use of an unlicensed medicinal product by a hospital or clinic in private practice.
19 Article 126a of Directive 2001/83 states that 'In the absence of a marketing authorisation or of a pending application for a medical product authorised in another Member State in accordance with this Directive, a Member State may for justified public health reasons authorise the placing on the market of the said medicinal product'.
20 The Medicines Authority Annual Reports, 2020.
21 Chetcuti M et al. (2018) Pharmaceutical issues during the review of European Marketing Authorisation Applications in Malta. Pharmaceutical Development and Technology, 23:6, 561–572.
22 Cilia M et al. (2018) Quality Issues Identified During the Evaluation of Biosimilars by the European Medicines Agency's Committee for Medicinal Products for Human Use. AAPS PharmSciTech, 19, 489.
24 In a University of Malta (Pharmacy Department, Faculty of Medicine and Surgery) study published as a research paper, out of 24 countries only 16 countries were found to have a national orphan drug (OD) or rare disease (RD) policy. Malta was found to have no national OD or RD plan, financial incentives or non-financial incentives. Malta's pricing of OD is 'free' 'upon passing HTA through therapeutic programme scheme'. Abbas, Amar & Vella, Janis & Azzopardi, Lilian & Serracino-Inglott, Anthony (2019) Orphan drug policies in different countries. Journal of Pharmaceutical Health Services Research, 10.1111/jphs.12305.
25 The Patents and Designs Act (Chapter 417 of the Laws of Malta), Article 27.
26 Developments in Article 126a authorisations in Malta, European Industrial Pharmacists Group newsletter November 2020.
28 The Pharmacovigilance Regulations, Article 8.
29 List of licensed pharmaceutical activities, Medicines Authority website www.medicinesauthority.gov.mt/licensed-pharmaceutical-activities.
30 The Medicines Authority Annual Report, 2020.
31 SL 458.32 Article 5(3).
32 List of licensed pharmaceutical activities, Medicines Authority website www.medicinesauthority.gov.mt/licensed-pharmaceutical-activities.
33 SL 458.36, Article 3(3).
34 SL 458.36, Article 2.
35 'Good practice' in relation to manufacturing practice, laboratory practice, distribution practice, clinical practice and dispensing practice means the standards for the proper execution of the relative activity as established by or under the Medicines Act, Chapter 458 of the Laws of Malta, Article 2.
36 SL 458.36, Article 7(5)(a)&(b).
37 The Medicines Act, Chapter 458 of the Laws of Malta, Article 2.
38 SL 458.36, Article 5.
39 The qualifications for designation of a QP are outlined in SL 458.36 Articles 9 and 10. The QP's responsibilities are listed in SL 458.36 Articles 11 and 12. The requirements of Directive 2001/83/EC as transposed into national legislation (the Medicines Act, Chapter 458 of the Laws of Malta, Article 38(1e) and SL 458.36, Article 9) must be fully complied with.
40 SL 458.37, Article 12.
41 Farrugia, C: Verification of Medicinal Products in Europe: An EIPG Perspective (Implementation of the new Delegated Act on Falsified Medicines, VAPI-UPIP seminar, Limelette, 2016).
44 State of Health in the EU, Malta, Country Health Profile 2021, European Observatory on Health Systems and Policies.
46 State of Health in the EU, Malta, Country Health Profile 2021, European Observatory on Health Systems and Policies.
47 Vella Bonanno P, et al. (2019) Proposal for a regulation on health technology assessment in Europe–opinions of policy makers, payers and academics from the field of HTA, Expert Review of Pharmacoeconomics & Outcomes Research, 19:3, 251–261.
48 SL 464.17, Paragraph 7(a).
49 SL 464.17, Paragraph 4(f).
50 SL 464.17, Paragraph 8.
51 Consumer Affairs Act, Chapter 378 of the Laws of Malta, Article 62 and 'Pharmaceutical Law in the EU and USA: The impact on Public Health and the Pharmaceutical Industry', University of Malta, Faculty of Laws, 2010.
52 Civil Code (Chapter 16 of the Laws of Malta), Section 1031.
53 Civil Code (Chapter 16 of the Laws of Malta), Section 1032.
54 Civil Code (Chapter 16 of the Laws of Malta), Section 1033.
55 P Vella Bonanno, International Conference, Competition and Pharmaceutical Policy in European Law, 'Availability of Medicines: A Case Study for Malta' (Iceland, 12 September 2008).
59 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: 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.
63 Government of Malta Press Release, February 2020, www.gov.mt/en/Government/DOI/Press%20Releases/Pages/2020/February/28/pr200338.aspx.
64 Through Advance Purchase Agreements with individual vaccine producers, the Commission secured the right to buy a specified number of vaccine doses in a given time frame and at a given price. In return, the Commission financed a part of the upfront costs from the €2.7 billion Emergency Support Instrument. This funding was considered a down-payment on the vaccines that Member States purchase. On 11 October 2021, the European Commission proposed to amend the EU Budget for 2021. It will provide an additional €450 million to reach the €1.3 billion which is needed to secure an additional 200 million doses of vaccines against covid-19 for low and middle-income countries through COVAX, as announced by President von der Leyen in her State of the Union speech, https://ec.europa.eu/info/live-work-travel-eu/coronavirus-response/public-health/eu-vaccines-strategy_en.