Contributed By GTG Advocates
Pharmaceuticals are defined as “medicinal products” under Maltese Law, and are primarily regulated under the Medicines Act (Cap 458 of the Laws of Malta) and the subsidiary legislation issued thereunder. Medical devices, on the other hand, are principally regulated under the Product Safety Act (Cap 427 of the Laws of Malta) and, more specifically, 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) issued thereunder. As an EU Member State, all related EU laws also apply in Malta.
The Medicines Authority and the Licensing Authority, constituted from the Superintendent of Public Health, are responsible for overseeing the pharmaceutical sector. Medical devices principally fall under the remit of the Malta Competition and Consumer Affairs Authority (“MCCAA”).
The Medicines Act provides for the constitution of a Medicines Review Board, which has the function of hearing appeals relating to marketing authorisations and matters relating to the safety, quality and efficacy of pharmaceuticals. An appeal before the Medicines Review Board needs to be filed within 14 days of the applicant for a marketing authorisation receiving the relative findings. Conversely, decisions of the Superintendent of Public Health (acting in the capacity of a Licensing Authority) are challenged before the First Hall of the Civil Court in terms of the general court procedures, whilst decisions of the MCCAA are appealed before the Competition and Consumer Appeals Tribunal. Such appeal needs to be filed within ten days.
The Borderline Classification Committee, within the Medicines Authority, is tasked with classifying borderline products into medicinal or non-medicinal products; until the classification has been determined, such products are deemed to be “borderline products”. A case-by-case approach is adopted in such assessments and, as a supplement to the Medicines Act, the Medicines Authority has issued guidelines as well as standard application forms for borderline product classification. In a nutshell, the guidelines outline the information and materials that must be provided for the classification to be undertaken, including dosage form, container type and packaging. Medicinal claims attaching to the product, intended use, mode of action, pharmacological properties as well as other similar authorised medicinal products already on the market are taken into consideration by the Borderline Classification Committee for the purposes of the classification of a borderline product.
It should be noted that cosmetic products are not deemed to be “medicinal products” and, instead, are primarily regulated under the Cosmetic Products Regulations (SL427.58 of the Laws of Malta). Furthermore, functional foods and nutraceuticals are not individually regulated, nor individually defined under Maltese Law, but are nevertheless deemed to be regulated under the Food Safety Act (Cap 449 of the Laws of Malta), specifically under the Food Supplements Regulations (SL 449.36 of the Laws of Malta), the Nutrition and Health Claims Regulations (SL449.53 of the Laws of Malta) and the Addition of Vitamins and Minerals of Certain Other Substances to Foods Regulations (SL 449.54 of the Laws of Malta). Special nutrition products the purpose of which is to supplement a normal diet and which are a concentrated source of nutrients are also primarily regulated under the Food Supplements Regulations (SL 449.36 of the Laws of Malta). The marketing and circulation of such products in Malta falls under the remit of the Food Safety Commission.
Medicinal products are categorised as either “Prescription-Only Medicines” (requiring a qualified doctor’s prescription) or “Over-the-Counter Products” (products that can be simply dispensed by a pharmacist without a prescription). Medicinal devices, on the other hand, are divided into classes in accordance with the risk presented to the consumer. In this respect, the Medical Devices Regulations set out criteria that need to be taken into account for the purposes of classifying a medical device, which mainly revolve around the degree of invasiveness, mode of action, duration of contact and impact on the body of the user. On this front, it should be noted that active implantable devices are classified as high-risk devices, whilst the risk of in vitro diagnostic medical devices is determined on the basis of their use.
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Clinical trials of pharmaceuticals are regulated under the Clinical Trials Regulations (SL 458.43 of the Laws of Malta), which transposes into Maltese Law European Directive 2001/20/EC regulating the conduct of clinical trials on human subjects where such clinical trials involve medicinal products in interventional trials.
The Good Clinical Practice and Requirements Regulations (SL 458.47 of the Laws of Malta) also supplement the aforementioned Clinical Trials Regulations and provide for good practices and procedures that must be adopted and provide for the safety, well-being and rights of the trial subject. Guidelines on the procedures to be implemented when carrying out clinical trials have also been issued by the Medicines Authority.
From a procedural perspective, a clinical trial of pharmaceuticals may be undertaken if its benefits outweigh any foreseeable risks, as determined by the Ethics Committee set up by the Licensing Authority. Authorisation of a “sponsor” is required – namely, authorisation of the person taking responsibility for the initiation, management and financing of the clinical trial. Such authorisation requires a favourable opinion from the Ethics Committee. In addition, the Licensing Authority must not inform the sponsor of any grounds of non-acceptance. In this respect, it should be noted that approvals are conferred for one particular trial at a time; the request for the processing of an approval needs to be determined by the Licensing Authority as rapidly as possible, and may not exceed 60 days.
Trials of medical devices are catered for under the Medical Devices Regulations, which provide that a mark of conformity (the CE mark) is required for the placement of a medical device in the market. This requires that a notified body must have carried out a conformity assessment procedure depending on the class of medical device. From a procedural aspect, a technical file needs to be submitted and is to include documentation intended to demonstrate the medical device’s conformity. As Malta is an EU Member State, the EU’s Clinical Trials Regulation (536/2014) will have direct effect in Malta when it becomes applicable.
Information regarding clinical trials of pharmaceuticals is available within the European Clinical Trials (“Eudra CT”) database, which sponsors of clinical trials are able to access, subject to registration. A similar database is not yet present for medical devices, although a publicly accessible database is expected to come into being in Malta when the EU’s Medical Devices Regulations (2017/745) come into effect.
There are no specific restrictions against using online tools to support clinical trials. Naturally, generic laws still apply when the use of online tools is made in support of clinical trials, and the use thereof must be undertaken in line with all laws of generic application. The data resulting from clinical trials would be deemed personal or sensitive data, depending on the nature of the resulting data itself, and the relevant determination is carried out in a manner in line with relevant EU data privacy laws in this respect – primarily, the EU General Data Protection Regulation (2016/679) (“GDPR”), which has direct effect in Malta as an EU jurisdiction. In this respect, it should also be noted that there are no restrictions against the transfer of such resulting data to third parties or affiliates, insofar as the transfer is carried out in compliance with the GDPR, the Data Protection Act, Cap. 586 of the Laws of Malta (“DPA”) and any generic laws that might be applicable. Naturally, the creation of databases containing personal or sensitive personal data would be subject to all applicable data protection laws insofar as the data can render a natural person identifiable.
The assessment process involved in obtaining a marketing authorisation (“MA”) and related criteria depend on the nature of the product, as set out under 1 Regulatory Framework, above. In this respect, there are three types of systems for obtaining an MA: the national, the European and the centralised MA system.
National MA procedures are regulated under the Medicines (Marketing Authorisation) Regulations (SL 458.34 of the Laws of Malta), and the relative authorisation is issued by the Licensing Authority.
The concept of European and centralised procedures in Malta is equivalent to that in other EU jurisdictions. Accordingly, the European procedures cover the mutual recognition of MAs, whilst the decentralised procedure covers MAs granted by the EU Commission.
To obtain a national MA, an application must be submitted to the Licensing Authority and must be accompanied by all information required under the Medicines (Marketing Authorisation) Regulations, including but not limited to a written confirmation that the manufacturer of the product has verified that the active substance complies with the principles of good manufacturing practices, a summary of the applicant’s pharmacovigilance system, a risk-management plan and a statement of the effect of the clinical trial held.
MAs are conferred for a five-year period, after which the MA can be renewed following a re-evaluation of the risk-benefit balance. To this end, a file on the quality, safety and efficacy, including evaluation data, is to be submitted at least nine months prior to the expiration of the MA for the purposes of its renewal. Upon successful renewal, the MA is valid for an unlimited period of time. However, the authority may raise grounds relating to pharmacovigilance, in which case renewal would instead be granted for one additional five-year term. In this regard, it should also be noted that an MA is not deemed to remain valid in Malta if the product is not placed in the market within three years of the MA being granted. Likewise, an MA ceases to have effect in respect of products that do not remain on the market for three consecutive years.
The MA holder may vary the MA through an application process with the Medicines Authority. There are four types of permissible variation, as follows:
As such, the process for varying an MA depends on the type of variation sought. From a procedural aspect, the electronic submission of documents is required, and a summary of the variation sought and appropriate application form and relevant information must be included, amongst other requirements.
Transfers of an MA are permitted, subject to the conditions required by the Medicines Authority, and are effected by notifying the Medicines Authority through specific forms for this purpose.
The Medicines (Marketing Authorisations) Regulations also provide that the Licensing Authority may, in exceptional circumstances, permit that a medicinal product is circulated in Malta without an adequate MA. Likewise, the distribution of unauthorised medicinal products may be permitted temporarily in response to a suspected or confirmed spread of pathogenic or chemical agents, toxins or nuclear radiation.
MA holders are subject to pharmacovigilance obligations. In this regard, a pharmacovigilance system must be in place and a regular audit thereof must be carried out. An obligation to operate risk-management systems may also be imposed on MA holders in cases where there are risks that might affect the risk-benefit balance. In this respect, the Pharmacovigilance Regulations (SL 485.35 of the Laws of Malta) provide that the Medicines Authority may not impose further obligations on this front unless there are justifiable grounds emerging from the specific pharmacovigilance activities. Additional obligations based on the reporting of suspected adverse reactions cannot be imposed.
It should be noted that legislation against falsified medicines is in place beyond the traditional intellectual property legislation. The Medicines Act has provisions against the adulteration of medicinal products, including that no person can add or abstract any substance that affects the composition of a product in an injurious manner. Persons cannot sell or supply products that have been deliberately and fraudulently mislabelled. Moreover, the Wholesale Distribution and Brokering of Medicinal Products and Active Substances Regulations (SL 458.37 of the Laws of Malta) implement EU Directive 2011/62/EU, which amended Directive 2001/83/EC on the Community code relating to medicinal products for human use, as regards the prevention of the entry into the legal supply chain of falsified medicinal products. Amongst other provisions, the Wholesale Distribution and Brokering of Medicinal Products and Active Substances Regulations provide that wholesale distributors shall verify that medicinal products received for distribution are not falsified products. The Licensing Authority may also take other necessary measures to prevent products suspected of being falsified from entering into the EU market for circulation, despite the fact that the products may not necessarily be intended for placement in the EU market. On this front, it should be noted that the Maltese legislation captures persons who knowingly or unknowingly supply such products, meaning that one cannot claim that they were not aware of the nature of such products as a defence.
MAs that are being processed by the authority cannot be accessed by the public, but the public can access a database of medicines that have been conferred an MA. A database of medicines that previously required a prescription but no longer do so is also publicly accessible.
The Medicines Authority may order a medicinal product to be recalled from the market in the interest of public safety. The Licensing Authority may also suspend, revoke, withdraw or vary an MA if the product is deemed harmful, if there is lack of therapeutic effect, if the risk-benefit balance is not favourable, if the qualitative and quantitative composition of the product is not declared, or if the necessary controls have not been properly carried out at the manufacturing stage. Suspension, revocation, withdrawal or variation may also be ordered where particulars supporting an application are incorrect or amended without authorisation, or when the packaging and labelling are not in accordance with the Medicines Act. Furthermore, the MA holder is not restricted from withdrawing a medicinal product from circulation.
With respect to medical devices, the authorisation procedure requires CE Marking, as noted above. The Technical Regulations Division within the MCCAA is the department primarily responsible on this front. The CE Marking may be retracted in cases where the standard utilised to give a product a CE Marking has changed, or where there has been other regulatory changes.
It should be noted, however, that not all medical devices require CE Marking. For instance, custom-made devices do not require CE Marking unless they are mass-produced. Additionally, even when CE Marking is an obligation, it is possible for a medical device to be authorised to be placed on the market without the prior obtainment of the CE Marking and relative undertaking of conformity assessment procedures if doing so is in the interest of the protection of public health.
From an ongoing obligations perspective, the Medical Devices Regulations also provide for post-market surveillance obligations, which are aimed at ensuring the safety of the medical device throughout its entire lifetime. Medical devices that are installed, maintained and used for their intended purpose yet compromise the health and safety of patients may be withdrawn from the market or prohibited or restricted by the Director of Market Surveillance (following interim measures).
If a device that is not in conformity with the relevant requirements bears the CE Marking, all appropriate measures shall be taken with regard to those responsible for affixing the CE Marking. The Market Surveillance Directorate can also carry out inspections whereby the manufacturer must make technical documentation available, including the CE declaration of conformity.
In accordance with the Medical Devices Regulations, regulatory data is to be stored and made accessible in a European databank that is accessible to the competent authorities. Furthermore, the staff of notified bodies must observe professional secrecy for all information gained throughout the course of their duties. Persons involved in applying the regulations pertaining to medical devices must also observe confidentiality with regards to the information collected throughout carrying out their tasks.
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Border measures against counterfeit pharmaceuticals and medical devices is in place under the purview of the Customs Authority.
There are currently no specific Maltese Laws that regulate the pricing of pharmaceutical products and medical devices. However, in practical terms, negotiations are undertaken between the MCCAA, the Medicines Authority and importers with respect to pricing. Participation by the private sector in such negotiations is voluntary. Where such negotiations are undertaken, an external reference procedure is in place, which is used to determine pricing on the basis of the relative price in other EU/EEA Member States.
In the context of government-dispensed medicinal products, it should be noted that the Directorate for Pharmaceutical Affairs is tasked with contributing to the fair pricing of medicines, which is based on the moment of procurement, maximum reference price, external reference price and guidance reference price. The Government Health Services Regulations (SL458.31 of the Laws of Malta) regulate the pricing for MA holders who wish to place their products within the Government’s Health Services. External reference pricing is utilised when it comes to the reimbursement of medicines in the Government Health Services sector.
The prescription and dispensing of medicinal products by pharmacies is regulated under the Prescription and Dispensing Requirements Rules (SL 458.49 of the Laws of Malta), which provide for the form in which a prescription is to be written and its content. Only pharmacists licensed to practise in Malta can dispense medicinal products against a prescription. The prescription itself cannot be older than six months, unless it is for antibiotics, in which case the prescription cannot be older than ten days. Prescription forms for free medical products are regulated under the Prescription Forms for Free Medicinal Rules (SL 458.24 of the Laws of Malta), which cover both medical and dental practitioners, and apply irrespective of the form that the prescription may take, insofar as the dispensing falls within the remit of the Social Security Act (Cap 318 of the Laws of Malta).
The advertising of medicinal products is primarily regulated by the Medicinal Products (Advertising) Regulations (SL 458.32 of the Laws of Malta), which transpose EU Directive 2004/27 EC into Maltese law. Guidance notes regarding the advertising of medicinal products intended for human use have also been issued by the Medicines Authority.
From a broadcasting perspective, it should be noted that the Broadcasting Act (Cap 350 of the Laws of Malta) contains rules on the broadcasting of adverts relating to medicinal products.
The Product Safety Act also contains rules addressing the advertising of medical devices. In all cases, the generic rules on comparative and misleading advertising under the Commercial Code (Cap 13 of the Laws of Malta) are also applicable.
An MA is required in order for a medicinal product to be lawfully advertised in Malta. However, advertising cannot be undertaken with respect to products that require a prescription, or that fall under the First Schedule to the Dangerous Drugs Ordinance (Cap 101 of the Laws of Malta) or the Third Schedule to the Medical and Kindred Professions Ordinance (Cap 31 of the Laws of Malta).
The advertising of medical devices cannot be prevented insofar as the medical device has acquired CE Marking and can thus be placed on the market.
The promotion of medical devices falls under the remit of the Advertising Committee within the Medicines Authority. This Committee is responsible for offering advice and information on advertising issues, for issuing conditions and guidelines on advertising, for monitoring the advertising of medicinal products, and for carrying out investigations of cases suspected to breach Maltese Law, including complaints in relation to the same.
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It should be noted that the Director General (Technical Regulations) has the power to impose (via an order in writing) conditions on product marketing, advertising and labelling requirements.
Enforcement of advertising regulations is carried out by the respective relevant authorities. Competitors and third parties with a legitimate interest can also make an application requesting the issuance of a compliance order.
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In promoting medical products to qualified persons who can prescribe or supply them, it is unlawful to offer gifts, pecuniary advantages or other benefits in kind (unless the gifts are inexpensive and immaterial). However, providing hospitality at professional or scientific events is permissible, insofar as the event is strictly for such purposes.
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The advertising of pharmaceuticals and medical devices is subject to the general principles of lawful advertising, as contained in consumer legislation and the Commercial Code. Amongst others, the advertising of pharmaceuticals and medical devices must encourage their proper and rational use, and the public must be informed to read the instructions. Advertising suggesting that one product is more effective than another is prohibited. Furthermore, all advertising must be in the Maltese or English language (with some limited exceptions that admit the use of the Italian language).
The Medicines Products (Injunction to Advertising) Regulations (SL 458.51 of the Laws of Malta) provide for compliance orders that may be issued by the Medicines Authority against an MA holder in the interest of consumer safety. A person in breach of advertising rules can be ordered to cease advertisements and to take any necessary measures. The authority may also impose administrative measures, or penalties.
There are no specific laws applicable to the advertisement of Medical Devices. Naturally, generic laws on advertisements still apply.
Whether to be used alone or in combination with other products, software falls within the definition of “medical device” for the purposes of the Medical Devices Regulations, including software intended by its manufacturer to be used specifically for diagnostic and/or therapeutic purposes. In turn, software for medical purposes must be validated against the state of the art, taking into account the principles relating to the development life cycle, risk management, validation and verification. However, no official direction has yet been provided in respect of medical apps.
Telecare is permissible under Maltese Law and, in terms of the Cross-Border Healthcare Regulations (SL 528.03 of the Laws of Malta), is considered to be provided from the Member State wherein the healthcare provider is established.
To date, there are no ad hoc social media or internet promotion rules applicable to medicines or medical devices, although the generic rules still apply. However, advertising through television or radio is regulated via its own ad hoc rules.
The Prescription and Dispensing Requirement Rules regulate both electronic and manual prescriptions. When electronically generated prescriptions are drawn up, they must include the same details as are applicable for manual prescriptions, and must also be signed; a digital signature is allowed.
In the case of prescriptions for free medicines, the Prescription Forms for Free Medicinals Rules regulate manual prescriptions, computer-generated prescriptions and e-prescriptions for products dispensed in terms of the Social Security Act. The Pharmacy of Your Choice (POYC) programme, a service offered by the Maltese Government, utilises computer-generated prescriptions, which can be used by medical practitioners to select medicines to which their patients are entitled.
The online sale of medicines or medical devices and the operation of online pharmacies in general are not directly regulated under Maltese Law, nor is the licensing thereof permissible under the Pharmacy Licence Regulations (SL 458.16 of the Laws of Malta). Nevertheless, guidelines with respect to the purchasing of medicines online have been issued by the Medicines Authority and provide that buying medicines online is permissible as long as the medicinal products are meant for personal use and do not otherwise breach Maltese Law. Medicinal products requiring prescriptions can only be lawfully obtained against a prescription and, accordingly, the suppliers of medicinal products are permitted to supply medicinal products requiring a prescription only if the prescription is indeed in place.
When it comes to the regulation of electronic health records, it should be noted that the Health Act (Cap 528 of the Laws of Malta) makes no distinction between medical records in electronic or physical format, nor is any such distinction made under the DPA. Accordingly, electronic health records are regulated in Malta in the same manner as any other records are regulated.
Manufacturing plants require authorisation and, amongst others, a Category E – Industrial Use permit. Furthermore, manufacturers of medicinal products require a licence in order to be able to operate. This licence is issued by the Licensing Authority for the manufacture, assembly or modification of a medicinal product. Manufacturers are also required to act in accordance with the Good Manufacturing Practice (GMP) guidelines. The licence is granted for a period determined by the Licensing Authority.
The application submitted to acquire such a manufacturing licence must indicate, among other things, the name of the medicinal product and pharmaceutical form or forms, evidence that the manufacturing place is suitable for its intended activity and sufficient for its purpose, the equipment to be used, and the control facilities.
However, adherence to conformity procedures is necessary with respect to medical device manufacturers.
Wholesale dealing in medicinal products requires a licence for the purposes of engaging in such activity, which is issued by the Licensing Authority. The procedure involves the submission of supporting documentation as well as site plans covering the storage areas. Wholesale dealers must also appoint a responsible person to represent them, who must be a registered pharmacist with the Pharmacy Council and is responsible for ensuring the security of the medicinal products and avoiding false and counterfeit products from entering the supply chain.
The scope of authorisation granted covers both the importation and exportation of medicinal products.
Distributors must communicate an inventory of changes to the Licensing Authority on an annual basis. Changes that affect the quality and safety of active substances need to be immediately notified. A breach of conditions related to the premises may lead to the revocation or suspension of the licence.
Wholesale dealing in medical devices is primarily regulated under the Product Safety Act. Wholesale dealers are under an obligation to assist in monitoring the safety of products placed on the market, and knowingly distributing unsafe products is deemed to be an offence. The Director General (Technical Regulations) may impose further restrictions on the placing of medical devices on the market.
As provided under 1.6 Intermediate Categories, medicinal products are classified as Prescription Only Medicines or Over the Counter Products.
The primary law of relevance with respect to the importation and exportation of pharmaceuticals is the Manufacture and Importation of Medicinal Products for Human Use Regulations (SL 458.36), whereas the importation of medical devices is primarily regulated as per the Product Safety Act.
Import regulations are primarily enforced via the Customs Authority, although the Commissioner for Revenue and the Licensing Authority also play a role.
Import tariff regulations are set out under the Import Duties Act (Cap 337 of the Laws of Malta). Product classification in Malta is carried out in terms of the Harmonised Standard – namely, the HS Code Number.
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An importer of record is necessary and can be any company set up in terms of Maltese law. In order to import medicinal products, the importer requires a licence; moreover, a registration form is to be submitted to the Licensing Authority at least 60 days prior to the intended importation. Certain medicinal products – such as but not limited to those prepared in a pharmacy in accordance with a medical prescription, those intended for development trials, and intermediate products intended for further processing by an authorised manufacturer – are not subject to the Manufacture and Importation of Medicinal Products for Human Use Regulations.
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The exportation of intangibles from Malta is generally not subject to control restrictions. However, control on dual-use export items is in place under the Dual-Use Items (Export Control) Regulations (SL 365.12 of the Laws of Malta), and such control restrictions also cover intangibles such as software and technology, as well as other items that can be used for both civil and military purposes. In this regard, it should be noted that the controls in place under the Dual-Use Items (Export Regulations) incorporate by reference the controls under Council Regulation No 428/2009. As a result, the controls in place also cover, amongst others, exports relating to biological materials, toxins, genetically modified organisms, pathogens and chemicals.
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Sanctions issued by the United Nations Security Council as well as sanctions imposed by the Council of the European Union are directly applicable into Maltese Law under the National Interest (Enabling Powers) Act (Cap 365 of the Laws of Malta). To date, there are no known embargoes affecting the Maltese pharmaceutical or medical device industry.
Furthermore, it should be noted that Malta is an EU Member State and thus benefits from the free movement of goods and services within the EU. Malta is also a member of the World Trade Organization and the General Agreement on Tariffs and Trade.
The Patents and Designs Act (Cap 417 of the Laws of Malta) and its subsidiary legislation regulate patents in Malta. Furthermore, it should be noted that Malta has acceded to the European Patent Convention, the Patent Co-operation Treaty and the Agreement on Trade-Related Aspects of Intellectual Property Rights (TRIPS). Ratification of the Unitary Patent Package has also been made by Malta.
When it comes to patentability, Malta’s Industrial Property Registrations Directorate (“Malta IPRD”) – commonly known as the Maltese “IP Office” – primarily acts as a receiving office for patent applications, carrying out only a formal examination of patent registration requirements. A substantive or scientific examination of the claims is not carried out in practice by the Malta IP Office. However, if patentability were to be challenged in the courts, it would be expected that the Maltese courts would primarily rely on case law at EPO level and on English case law, as the original source of Maltese patent laws.
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The term of protection conferred on inventions covering pharmaceuticals can be extended in the field of medicinal products through supplementary protection certificates (“SPCs”) for a period of up to five years from the expiry of the term of the basic patent. From a procedural aspect, SPCs can be applied for by filing the relative forms with the Malta IPRD before the basic patent expires and, in turn, the SPCs’ protection would start from the end of the 20th anniversary from the filing date.
To date, there is no known local precedent in relation to the infringement of second and subsequent patents of pharmaceutical products. Indeed, patent litigation remains uncommon in Malta, with only a handful of cases being determined by the Maltese courts.
Patent infringement in Malta covers (in brief) the following actions when they are carried out without proper authorisation from the right-holder concerned:
However, due to Malta’s broad interpretation of the Roche Bolar Exemption, applying for a marketing authorisation throughout the validity of another patent is not deemed to infringe patent rights.
Private and non-commercial use, experimental and scientific research, extemporaneous preparations, development and information presentation and passage in transit are defences that can be raised against a patent infringement, or, more accurately, are acts that are exempt from patent infringement. In this respect, it should be noted that Malta applies a very extensive interpretation of the Roche Bolar Exemption, which has resulted in a flourishing generic drug industry in Malta.
Proceedings for patent infringement can be brought by the proprietor of a patent, as well as in certain cases by licensees. Destruction of the infringing goods, forfeiture, seizure, fines, damages (including moral damages) and criminal repercussions may be incurred as a result of patent infringement. Furthermore, non-infringement declarations are possible before the Patents Tribunal.
Patent litigation is somewhat uncommon in Malta. That said, it would be expected that a typical patent infringement would involve the institution of two concurrent actions to revoke or invalidate a patent, make civil claims for infringement and to apply for declarations of non-infringement require procedures before the Patents Tribunal, whereas a claim for damages arising from an infringement falls within the remit of the First Hall of Civil Court. Criminal procedures are then held before the criminal courts. In infringement-related proceedings, invalidity is an available defence and may be invoked both in proceedings before the Patents Tribunal and in proceedings before the Civil Court. Other defences of a generic legal nature such as prescription are also available.
A request for revocation of a patent can be filed either with the Malta IP Office, or with the newly established Patents Tribunal. Furthermore, the Patents Tribunal has jurisdiction to hear and determine civil claims for infringement, claims for declarations of non-infringement and precautionary actions. On the other hand, recourse for damages arising out of patent infringement is to be made in the Civil Court, First Hall. Thus, two separate proceedings would be expected in patent infringement.
There are no clearing-the-way requirements for generic market entry imposed under Maltese Laws. However, patent searches and clearance opinions as a privately pursued compliance process for ensuring lawful generic market entrance and for ensuring that patents are not infringed is common practice in Malta. As noted above, the Patent and Designs Act also provides for declarations of non-infringement although it is understood that such declarations have rarely been used in Malta, if ever.
The legislation that governs anti-counterfeiting in Malta from an intellectual property perspective is primarily the Intellectual Property Rights (Cross-Border Measures) Act (Cap 414 of the Laws of Malta) together with Customs Regulation 1383/2003 concerning customs actions against goods suspected of infringing certain intellectual property rights and the measures to be taken against goods found to have infringed such rights. The Patents and Designs Act together with the Enforcement of Intellectual Property Rights (Regulation) Act (Cap 488 of the Laws of Malta) and the Criminal Code (Cap 9 of the Laws of Malta) are also typically relevant.
The Maltese customs procedure requires a separate application with the Comptroller of Customs wherein a detailed description of the goods in question is provided to the Comptroller together with proof that one is the holder of the rights in question and prima facie evidence that goods infringe the rights of the right-holder.
The Trademarks Act (Cap 416 of the Laws of Malta) does not any contain specific restrictions on trade marks that can be used for pharmaceuticals or medical devices. Naturally, however, restrictions of a generic nature are in place, such as restrictions on trade marks bearing national emblems. That said, it should be noted that Maltese trade mark law does not restrict, in any way, the lawful importation or distribution of genuine pharmaceutical products and medical devices from other markets, although unregistered trade marks would need to be taken into consideration as well, as they are recognised separately by way of use under the Commercial Code.
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IP protection for the trade dress or design of a pharmaceutical or a medical device is available in Malta, and is generally sought under a registered design or a trade mark. Copyright and unregistered design rights may also apply. Crucially, it should be noted that if protection is sought under a registered design right for a medical device, the protection conferred under the Patents and Designs Act would only extend to its aesthetic elements. Functional elements would not be captured within the scope of registered design protection.
It should be noted that data exclusivity as a concept is present under Maltese Law with respect to medicinal products and, in this regard, a six-year data exclusivity period is applicable under the Medicines Act.
The Competition Act (Cap 379 of the Laws of Malta) applies in a generic nature and addresses competition issues specifically in the context of pharmaceuticals or medical devices. Proceedings under the Competition Act can be brought forward by any “injured person” – ie, any person who has suffered harm caused by an infringement of competition law. Such court proceedings are brought before the civil courts in accordance with the procedures applicable to civil cases under the Code of Organisation and Civil Procedure (Cap 12 of the Laws of Malta). Decisions of the MCCAA (the authority tasked with oversight of competition matters in Malta) can be appealed before the Competition and Consumer Appeals Tribunal.
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It should be noted that local litigation on competition matters is somewhat rare in Malta, and to date there is no known precedent case law specifically relating to competition matters in the pharmaceutical or medical device industry. There is also limited commentary on how agreements, arrangements and concerted business practices that appreciably prevent, restrict or distort competition as well as abuse of dominant positions and concentrations run against Malta’s competition laws specifically in said industries.
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Various legal provisions may need to be considered in share deals, asset deals, joint ventures, licence agreements and other commercial agreements related to the pharmaceutical or medical device industry. Typically, the most relevant legal provisions are contained within the Commercial Code, the Civil Code, the Companies Act, the Data Protection Act, the Patents and Designs Act, the Trademarks Act, the Copyright Act, the Competition Act, the Product Safety Act and the Medicines Act.
Earn-out clauses, contingent value rights and go-shopping are not uncommon in the context of M&A transactions generally. It is also customary for the purchase price in an M&A deal to be subject to conditions precedent, and a traditional completion accounts approach is probably the most typical price adjustment utilised in Malta.
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Deal-protection agreements are also used in Malta, with the most customary deal-protection agreements most likely to be escrow agreements and non-disclosure agreements.
It should be noted that local competition laws require the notification and approval of concentrations between undertakings. In this regard, in terms of the Control of Concentrations Regulations (SL 379.08 of the Laws of Malta), such a concentration notification requirement applies when the aggregate turnover in Malta of the undertakings concerned exceeded EUR2,329,373.40 in the preceding financial year, and each of the undertakings concerned had a turnover in Malta equivalent to at least 10% of the combined aggregate turnover of the undertakings concerned.
Generally speaking, in the tax treatment of asset deals that do not result in the transfer of the going concern of the business, a calculation needs to be made on whether there is a tax gain on that transfer – if there is, then the gain is subject to tax. On the other hand, the taxation of share deals depends, amongst other factors, on whether the transfer involves a seller that is resident or domiciled in Malta and whether the company owns immovable property. If both requirements do not apply, then the share deal may be exempt from capital gains tax.
Prudent licensees typically protect their position against the insolvency of licensors through contractual terms, escrows and sometimes the taking-out of security over IP assets.
Aiding and abetting money laundering and terrorism is the most likely form of white-collar crime focused on by prosecutors and authorities in Malta, together with fraud, bribery and tax evasion.
When it comes to the most important dos in the context of investigations of white-collar crimes, it is typically suggested that policies and a documentary trail of evidence should be in place, as investigators in Malta tend to give importance to written procedures.
No response provided.
Investigations related to white-collar crimes in the context of the pharmaceutical and medical device industries would not be expected to be particularly dissimilar to investigations into companies operating in other industries locally.
A specific product liability regime is in place in Malta, with the main difference from other liability regimes under Maltese law being that concepts of strict liability also apply. However, it should be noted that a pharmaceutical may be excluded from the definition of “product” as provided under the Product Safety Act and thus product liability is typically mostly relevant in the context of medical devices.
A product is deemed defective if it fails to provide the safety a person is entitled to expect, taking all circumstances into account, including the presentation of the product, how it was marketed and any directions and warning provided, the use to which it could reasonably be expected that the product would be put, and the time when the product was put into circulation.
Regarding the standard of proof for causation, it should be noted that the principles adopted in civil cases apply – ie, whoever alleges must prove, and liability is determined in the context of a balance of probabilities. Furthermore, under the Consumer Affairs Act, whilst the injured party bears the burden of proving the damage, the defect and the causal nexus between the two, said party does not bear the burden of proving fault.
In terms of the Consumer Affairs Act, it is not possible to find in favour of product liability if the producer did not put the product into circulation, if the defect causing the damage did not exist when the product was first put into circulation, if the product was not manufactured to be sold to consumers or if the defect could not be discovered due to the scientific and technical knowledge at the time that the product was produced. Naturally, defences on the merit of claims and other generic defences such as prescription are also possible.
Potentially, both producers and distributors could be liable for product liability claims. Furthermore, a “regulatory compliance defence” is available under Maltese law, and requires proof that the defect in question is due to compliance with a mandatory requirement imposed by law or by a public authority.
The concept of “market-share liability” is, as yet, alien to Maltese Law, but collective actions are possible (although rare).
The prescriptive period applicable for injured parties to institute proceedings under the Consumer Affairs Act is typically three years from the date when the injured party became aware of the damage, the defect and the identity of the producer. However, irrespective of this period of prescription, it should be noted that proceedings against producers are generally prescribed upon the lapse of ten years from the date on which the product was put into circulation.
Consumers are entitled to have adequate information about goods or services, and this information should be clear, correct, and not misleading. Furthermore, the Director General within the MCCAA has the power to obtain information from any persons, in any manner, including orally or via the production of documents, as he or she may consider necessary (although a person is exempt from replying if their answer may incriminate themselves).
When it comes to the forms of damages available in Malta, actual material damages (pecuniary) are typically granted. However, moral damages are increasingly being recognised, particularly in the context of intellectual property cases.
The damages that can be granted are not capped.
Cases relating to the unlawful importation, sale or possession of drugs tend to be the most common in Malta.
Within the Maltese court system, a trial-by-jury process is only available in the criminal courts. Opting to have the case heard by a judge instead of a jury is sometimes possible.
In general terms, there are no disclosure obligations for documents or other evidence, although similar obligations do exist under intellectual property laws.
There are no known ongoing discussions regarding material changes to the national legal regimes for pharmaceuticals. However, it should be noted that medical cannabis has recently been legalised, and there are increasing ongoing discussions relating to the legalisation of recreational cannabis. As an EU Member State, discussions and changes at the EU level would affect Maltese Law.
The legislation governing privacy and data protection in Malta is the Data Protection Act, Cap. 586 of the Laws of Malta (“DPA”), together with the subsidiary legislation issued thereunder. As an EU Member State, EU legislation in relation to the data protection also applies in Malta, including the GDPR.
The Office of the Information and Data Protection Commissioner (“IDPC”) is the regulatory body responsible for enforcing the privacy and data protection framework in Malta.
In terms of the DPA and the GDPR, health-related information is deemed a “special category of data” and, as such, the processing thereof is generally prohibited, unless a derogation permitting the processing of such data applies. Where the processing of health-related information is permitted, that processing is subject to the same stricter conditions as required in this regard by the GDPR.
Breaches of privacy and data protection legislation are subject to the same fines as provided under the GDPR. However, it should be noted that the fine applicable to public bodies and public authorities is capped at a maximum of EUR50,000.
There are no special requirements applicable in relation to cloud platforms; the general data protection rules apply. In this context, it should be noted that the GDPR’s rules in respect of third-country data transfers have direct effect in Malta. However, on a general basis, it is not unlawful to transfer patient data to the cloud or to any other technology, insofar as this is undertaken in compliance with data protection laws, and with appropriate technical and organisational security measures.