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Pharmaceutical Law.

Project Description

 

  • 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

 

 Why Malta?

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

Tax benefits
Companies registered or resident in Malta are subject to income tax on chargeable income at a standard rate of 35%. Malta’s full imputation system ensures that resident and non-resident shareholders are entitled to claim and receive a tax credit equivalent to 2/3rds or 5/7ths or 6/7ths or 100% of the income tax paid by the Malta company upon the distribution of a dividend.  This effectively results in net tax payment of 6.25% or 10% or 5% respectively.

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
  • Biotechnology
  • 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”).

Industry support and R&D funding
Beneficial incentives available to pharmaceutical and biotech companies operating in Malta include the provision of:

–        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.

Global product safety and quality through EU regulation
The laws regulating medicinal products for human use, medical devices and chemicals in Malta are fully harmonised with the relevant European Union law regime. Malta grants Good Manufacturing Practice (EU GMP) and Good Distribution Practice (EU GDP) certification through its regulatory authorities.  As an EU member state, Malta is a party to Mutual Recognition Agreements (MRAs) for Good Manufacturing Practice (GMP) with Switzerland, Australia, New Zealand, Canada and Japan.Several manufacturing plants and facilities in Malta successfully undergo U.S. Food and Drug Administration (FDA) inspections.  In December 2011, the U.S. Food and Drug Administration (FDA), and the European Medicines Agency (EMA), committed to further collaboration in Good Manufacturing Practice (GMP) inspection programs for human and veterinary pharmaceutical products.

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.

Virtual Wholesale Dealing and Virtual Importation – an opportunity for tax optimisation
A company registered in Malta for the carrying out of the sale, purchase and distribution of medicinal products within the EU, or the importation of medicinal products from a non-EU member state into the EU, may contract out all physical handling activity to a European licensed wholesale dealer or importer while fully benefiting from Malta’s attractive tax regime.

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.

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