Pharmaceutical Companies in Malta amidst Brexit

A Hub for the Biotech Industry in the EU

Dr. Silvana Zammit | 07 Mar 2019

Malta as a Hub for the Pharma  Biotech Industry

The Island’s Malta’s Patent Regime for Pharmaceutical Companies in Malta

Malta’s accession to the European Union (EU) in 2004 and the Eurozone in 2008, together with its geographic position and highly professional and specialised workforce, has undoubtedly boosted Malta’s reputation in becoming a jurisdiction of choice for the establishment of Pharmaceutical & Biotech companies. In this regard, the EU regulatory framework ensures that pharmaceutical products are not only efficacious, but also safe to be used by consumers; thereby providing increased reputability to companies operating from the Maltese jurisdiction.

One of the focal pillars in establishing reputability of pharmaceutical products produced and/or distributed by entities established in Malta is that such products undergo a thorough examination and evaluation prior to being placed on the market. In this respect, the Malta Medicines Authority, in accordance with the provisions of the Medicines Act and the Medicines (Marketing Authorisation) Regulations enacted in Malta, requires medicinal products intended for human use to be granted Marketing Authorisation prior to being placed on the market.

Nevertheless, Malta’s accession to the EU enables pharmaceutical companies established in Malta to benefit from the Mutual Recognition Procedure wherein Marketing Authorisation granted by the competent authority of a Member State within the EU shall be mutually recognised in Malta. It follows that a Marketing Authorisation obtained in Malta may also be used to market medicinal products in other EU Member States, with such distribution being further facilitated by virtue of the principle of freedom of establishment, which is one of the salient principles of the EU internal market.

The Challenges attributed with the Amendment to the UK’s Regulatory Framework

Further to EU laws and regulations, Market Authorisation holders must be located in the European Economic Area (EEA). Regulatory procedures (such as quality control and pharmacovigilance) must be carried out at sites in the EEA.
 
A ‘no-deal’ Brexit vote may result in Marketing Authorisations granted to UK companies being deemed as invalid, thereby precluding Market Authorisation holders from being able to supply medicines into the EU. Similarly, such a negative vote – a scenario that seems increasingly likely – will result in product licenses and sites for testing and certification being moved from the UK to another territory in the EEA.

Accordingly, the UK would potentially need to set up its own separate system for licensing, clinical trials, and drug safety monitoring and pharmacovigilance, albeit posing a number of issues, including additional administrative hurdles for licensing, as well as delays in UK access to new medicines and drug safety updates.

Malta’s Patent Regime

When choosing the most appropriate jurisdiction for which patent protection is sought, the applicant’s primary focus and aim ought to be on the reliability and dependability of that jurisdiction’s patent law system. 

In this respect, Maltese legislation provides effective protection to proprietors of a patent against third parties and grants said proprietors with twenty years of exclusive protection upon the invention as from the date of the filing of the patent application.

Similarly, the relatively low number of patent registrations in Malta provides an array of possibilities for pharmaceutical manufacturers to obtain the registration of patents in the domestic market. The significance of obtaining a national patent is further highlighted in light of Maltese legislation incorporating all obligations arising from the Patent Cooperation Treaty and the European Patent Convention. This implies that the protection of Maltese industrial property rights is not limited to the Malta’s territorial boundaries but automatically extends to other member and signatory countries.

Pharmaceutical Companies in Malta Benefit from Roche Bolar Provision

Furthermore, Malta is one of the few EU Member States to have adopted a very pro-active approach which fully embraces the so-called Bolar Provision. In this regard, the Bolar Provision was implemented into Maltese legislation as early as 2003, hence even before Malta’s accession to the EU.

The Bolar Provision relates to circumstances wherein the proprietors of a patent are precluded from preventing third parties from performing any act in relation to the subject-matter so protected by patent laws. Nevertheless, unlike several other EU Member States, Malta adopts a wider interpretation of this exemption and allows companies to carry out clinical trials and commercial testing for the purposes of obtaining regulatory approval, or other commercial purposes, prior to the expiration of the lifetime of the patent concerned. Accordingly, this exemption does not only permit use for purely experimental purposes and scientific research, but also extends to acts done privately and for non-commercial purposes, as well as acts done for the development and presentation of information as required under Maltese or foreign legislation regulating the production, use or sale of medicinal or phytopharmaceutical product.

It follows that, further to Malta’s interpretation of the Bolar Provision, a pharmaceutical company established in Malta may benefit and gain a competitive edge in this highly competitive market by allowing and permitting the development of generic drugs and the completion of all the necessary preparatory work prior to the expiry term of the competitors’ products’ patent. This allows the pharmaceutical company established in Malta to put their products on the market without undue delay upon the expiration of the patent concerned. 

Pharmaceutical Companies in Malta: A strong Biotech Infrastructure

Malta continuously strives to provide state-of-the-art facilities for pharmaceutical and biotech companies established in its jurisdiction. In this respect, the Malta Life Sciences Park can be identified as one of the main hubs made available to pharmaceutical and biotech companies. The Malta Life Sciences Park is equipped with state-of-the-art laboratories, and a number of shared facilities, such as offices, seminar room and meeting rooms which aim at assisting pharmaceutical and biotech companies conduct research, develop products and maintain a dominant position in the market.

Chetcuti Cauchi Pharmaceutical & Biotech Industry Team

The firm’s Pharmaceuticals & Biotech Industry team is made up of intellectual property, tax and corporate lawyers, as well as advisors that assist companies to set up in Malta and later on comply with all necessary regulatory, accounting and back office procedures. We work hand in hand with our Intellectual Property team in order to assist clients with all aspects related to patent protection, bolar exemption procedures and trademark protection.


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Dr Silvana Zammit

Partner, Global Property, Yachts & Aircraft

+356 22056423

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