Pharmaceutical law in Malta
Malta is the European Union’s smallest Member State and has implemented the EU medicines and medical devices regimes. 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.
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 pharmaceutical activities, as well as establishing licensing and marketing procedures.
The Medicines Authority is headed by a Chief Executive Officer. 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 several directorates and appoints its own officers and employees.
In Malta, to date, medical devices are regulated and authorised by the Malta Competition and Consumer Affairs Authority (MCCAA), although medical devices are planned to be regulated by the Licensing Authority and Medicines Authority in the future.
Legislation–medicines and medical devices
‘Medicinal products are defined and regulated by the Medicines Act (Chapter 458 of the Laws of Malta) and its subsidiary legislation. Medical devices are regulated by the Product Safety Act (Chapter 427 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).
Malta’s pharmaceutical industry
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. More than 30 established international pharmaceutical brand names operate in Malta, including several US mega-cap corporations.
In terms of the latest industry developments, in 2019, Aurobindo Pharma (Malta) Limited announced the company will invest in oncology research and set up a highly specialised new oncology laboratory in Malta to test oncology medicines destined for the EU and African markets. Aurobindo Pharma, the tenth-largest generic company by sales globally, has been established in Malta for the past 13 years and now employs 150 people.
Companies must adhere to EU requirements in manufacturing, licensing and distribution of pharmaceuticals, active pharmaceutical ingredients and medical devices, and most companies also receive US Food and Drug Administration (USFDA) accreditation.
The pharmaceutical industry has evolved considerably 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, 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 Chamber of Commerce members include active pharmaceutical ingredient (API) manufacturers, finished dosage form manufacturers, repackaging and labelling companies, wholesale dealers, brokers, and pharmacists.
AnthiaZammit Legal is a member of the Chamber of Commerce, Enterprise, and Industry and formerly served as Legal Counsel to the Healthcare Business Section.
- Handling of policy and regulatory matters before the European Commission, European agencies and national regulatory authorities.
- Advice on regulatory compliance with Pharmaceutical Law (medicines legislation) requirements, including product liability, importer and wholesale dealer’s licenses, issues raised by regulations on orphan medicines, paediatrics medicines and advanced therapies, pharmacy licenses (human and veterinary), pharmacy management, internet pharmacies, parallel importation, parallel distribution, packaging and labelling, as well as manufacture (GMP) and distribution (GDP) certification.
- Advice and assistance in the process of attaining marketing authorisations of medicinal products for human use in European Member States (through national, decentralised or mutual recognition procedures) and from the European Medicines Agency and European Commission through the centralised procedure.
- Advice on post-market obligations including pharmacovigilance, advertising of medicinal products, information to patients, data protection and classification of medicines.
- Advice on pharmaceutical pricing issues
- Advice on the application of the Roche-Bolar exemption in generic drug development
- Advice on legal, regulatory and public policy issues concerning nanotechnology
- Counsel on development of personalised medicine therapies and assessment of the legal implications of pharmacogenomics and pharmacogenetics
- Advice regarding the regulatory framework for medical devices
- Advice on compliance with the European chemicals law regime (REACH)
- Advice on European Intellectual Property Rights enforcement and Customs regulation
- Assistance in patent registration, trademark registration, the European Community Trademark, designs and copyright
- Counsel on hospital and clinic licensure and certification, healthcare services quality-control, resource-allocation and patients’ rights
- Assistance in fulfilment of obligations under Occupational Health and Safety law, including the drafting of health and safety policies, advice on compliance with legislation and judicial representation.
- Assistance in public procurement of medical supplies including advice on European Procurement law and the handling of public contract and tender processes through pre-qualification, selection, negotiation and award
- Risk Management and Policy Impact Assessment including review of promotional and marketing materials and sales practices, product development strategy and review of regulatory compliance operations to assess compliance to the regulatory authority’s standards
- Dispute resolution and judicial representation in medical negligence and medical malpractice claims
- Negotiation and drafting of corporate and commercial agreements
- Tax consultancy
Strong industry presence
As a member state of the European Union and the euro zone, Malta demonstrates its commitment in providing tailor-made support to its pharmaceutical and life sciences industries – comprising licensed wholesale distributors, importers, re-packagers and manufacturers of finished dosage forms, including non sterile solid dosage forms (tablets and capsules), active pharmaceutical ingredients (APIs), medical gases and medical devices. The total value of Malta’s pharmaceutical exports in 2010 exceeded €208 million ($275 million).
The presence of renowned corporations such as Actavis, Watson, Siegfried, Medichem and Baxter are a testament to Malta’s success in providing the ideal business environment for the launch of pharmaceuticals and medical devices into the European, U.S., North African and Middle Eastern markets. Operating in an increasingly globalised industry, these companies benefit from the fact that English is an official language of Malta
Advantageous tax credits that are deductible from tax due on profits from “qualifying activities” are offered to companies engaged in such qualifying activities which include:
- Production, manufacturing and processing of pharmaceuticals
- Research &Development (R&D) activities and related services
- Intellectual Property (tax exemption on royalties)
- investment in healthcare services and medical equipment
The supply of pharmaceutical goods qualifies for an exemption with credit for Value Added Tax (“zero-rated”).
– custom-built industrial premises at low rates of rent
– preferential loan financing
– loan guarantees
– assistance in employee training.
The BioMalta Campus, an investment of €30 million ($40 million) co-financed by the European Union to be overseen by the BioMalta Foundation, is expected to further augment Malta’s R&D infrastructure and long-standing tradition in the healthcare, pharmaceutical and biotech industries.
The European Union also offers funding to collaborative research projects in order to support R&D and innovation which improves human health e.g. the Innovative Medicines Initiative (IMI) which is a public-private partnership between the European Commission, and the European Federation of Pharmaceutical Industries and Associations (EFPIA) having a total budget of €2 billion.
Malta’s national competent authority engages in harmonisation of medicines regulation via the International Conference on Harmonisation of Technical Requirements for Registration of Pharmaceuticals for Human Use (ICH), and joined the Pharmaceutical Inspection Cooperation/Scheme (PIC/S) which is an international organisation of pharmaceutical manufacturing inspectorates from 39 countries.
Malta’s national competent authority accepts applications as Reference Member State in the Decentralised Procedure in accordance with Article 10 of Directive 2001/83/EC, as amended.
A business operating as a virtual wholesale dealer or virtual importer is required to hold a valid wholesale dealers license or importer’s license issued by Malta’s national competent authority and comply with good distribution practice (GDP) or good manufacturing practice (GMP) standards under EU law.