Abstract
In Malta, anti-competitive conduct is regulated by the Competition Act and also the Treaty provisions. The law is applied across the board in the pharmaceuticals industry, but there are no specific guidelines issued by the Malta National Competition Authority. From a regulatory perspective, Malta has a flexible approach to generics at all stages. Malta applies the Roche Bolar exemption to manufacturers based in Malta. In distribution and supply, the regulators issue licences for parallel importing and also allow pharmacists to dispense generics (despite references to originators). The government also actively pursues the purchase of generics and insists on the indication of the active ingredient in its procurement processes. Malta also applies de facto price control in the private sector through a voluntary price referencing agreement beween governement and stakeholders in the industry.
This is a preview of subscription content, log in via an institution to check access.
Access this chapter
Tax calculation will be finalised at checkout
Purchases are for personal use only
Notes
- 1.
Competition Act, Chapter 379 of the Laws of Malta.
- 2.
Competition Act, Article 5(1), which reads as follows: ‘Subject to the provisions of this Act, the following is prohibited, that is to say any agreement between undertakings, any decision by an association of undertakings and any concerted practice between undertakings having the object or effect of preventing, restricting or distorting competition within Malta or any part of Malta and in particular, but without prejudice to the generality of this sub-article, any agreement, decision or practice which:
-
(a)
directly or indirectly fixes the purchase or selling price or other trading conditions; or
-
(b)
limits or controls production, markets, technical development or investment; or
-
(c)
shares markets or sources of supply; or
-
(d)
imposes the application of dissimilar conditions to equivalent transactions with other parties outside such agreement, thereby placing them at a competitive disadvantage; or
-
(e)
makes the conclusion of contracts subject to the acceptance by the other parties of supplementary obligations which, by their nature or according to commercial usage, have no connection with the subject of such contracts’.
-
(a)
- 3.
Consolidated version of the Treaty on the Functioning of the European Union [2012] OJ C326/47.
- 4.
Competition Act, Article 9(1), which reads as follows: ‘Any abuse by one or more undertakings of a dominant position within Malta or any part of Malta is prohibited’.
- 5.
Competition Act, Article 2.
- 6.
Subsidiary Legislation 379.08 of the Laws of Malta.
- 7.
The only reported merger control decision by the Malta NCA related to the pharmaceutical industry is Acquisition by BC Partners of Pharmathen SA [COMP-MCCAA/10/2015] (1 July 2015) which cleared the acquisition by a private equity firm (which indirectly held shares in a pharmaceutical contract development manufacturing organisation) of a pharmaceutical company focused on developing, manufacturing and out-licensing of complex generic drugs mainly operating in the CDMO market.
- 8.
In Police v Brady Abela, Court of Magistrates (Malta), Criminal Jurisdiction [1231/2008] (7 April 2010) the respondent was accused by the Police, on behalf of the Medicines Authority, of selling medicines in Malta without market authorisation, without a wholesale licence and from a place which was not an authorised pharmacy as if he were a pharmacist. The Court of Magistrates did not find the respondent to be guilty since the Medicines Authority failed to put him in default by means of a notice. It did, however, order the confiscation and destruction of the medicinal products being sold by the respondent and also order the respondent to pay €23,000 in fines in relation to breaches of intellectual property law (the medicinal products were counterfeit). Interestingly in Police v Tarek Abd Suliman, Court of Magistrates (Malta), Criminal Jurisdiction [710/2007] (4 September 2007) the public enforcement was pursued by the Police, on behalf of the customs authorities in Malta, against the respondent for bringing over 1000 Anabol tablets without any authorisation under the Medicines Act. It appeared that there was an exception which was customarily accepted that a person travelling to Malta could bring an amount for ‘personal use’. The Court of Magistrates held that it was not convinced beyond reasonable doubt (the relevant test under Maltese criminal law) that the amount of 1000 tablets was not for personal use. Therefore, it held that the respondent was not guilty.
- 9.
Examples include: Joanne Cini v Superintendent of Public Health, Court of Magistrates (Gozo) Superior Jurisdiction (14 April 2011) [17/2011]; Joseph Spiteri et v Director General of the Department of Public Health, First Hall Civil Court (23 February 2012) [933/2006]; Chemimart Limited v Superintendent of Public Health, First Hall Civil Court (17 February 2014) [73/2011].
- 10.
Code of Organisation and Civil Procedure, Chapter 12 of the Laws of Malta, Article 469A.
- 11.
This is in turn based on a combination of the following factors: the number of pharmacies within the statutory boundaries of any town or village, the geographical equidistance based on walking distance from one another and a ratio per pharmacy according to the number of inhabitants. See Pharmacy Licence Regulations (Subsidiary Legislation 458.16 of the Laws of Malta), Regulation 4. Interestingly, Pharmacies (Opening Hours) Regulations (Subsidiary Legislation 458.28 of the Laws of Malta) in certain instances provides that pharmacies may not be open on Saturday afternoons or Sundays unless allowed to do so by a roster issued by the Superintendent of Public Health.
- 12.
An example is Malta Communications Authority, Decision on the provision of dedicated capacity over leased lines in Malta: Market definition, the state of competition & the setting of remedies (12 December 2012) [MCA/D/12-1441].
- 13.
An example is Malta Resources Authority, Decision on the complaint of Shell, as represented in Malta by Attard Services Limited, against Enemalta Corporation with regard to providing of fuel and oil handling services (9 June 2005) [Reference 02/ED]. This decision was subsequently overturned at appeal, but competition law analysis remained central to the analysis. See Attard Services Limited noe v Malta Resources Authority, Court of Appeal (9 January 2008) [Appeal Number 6/2007].
- 14.
Chapter 378 of the Laws of Malta, Article 51B et sequitur. These provisions transpose Directive 2005/29/EC concerning unfair business-to-consumer commercial practices in the internal market.
- 15.
Ibid., Article 51B(2). Articles 51B(3) provides that a commercial practice shall be unfair if it is misleading in terms of Articles 51C and 51D or if it is aggressive in terms of Article 51E.
- 16.
This refers to pre-litigation judicial notices, such as judicial protests and judicial letters, intend mostly to interrupt the period of prescription and to notify the opposing party.
- 17.
Chapter 520 of the Laws of Malta.
- 18.
We report that there were a handful of cases where a class action was filed on the back of the Collective Proceedings Act, but these were exclusively related to breaches of the Malta consumer protection law and specifically within the travel booking sector.
- 19.
Chapter 417 of the Laws of Malta.
- 20.
Roche Products v Bolar Pharamaceuticals, United States Court of Appeals, Federal Circuit (23 April 1984) 21 USPQ 937 (Fed. Cir. 1984). This is enshrined (to a certain extent) by Article 10(6) of the so-called EU Bolar Directive (Directive 2001/83/EC on the Community code relating to medicinal products for human use, as amended). This provision of the EU Bolar Directive has been transposed word for word by the Medicines (Marketing Authorisation) Regulations (Subsidiary Legislation 458.34 of the Laws of Malta). The EU Bolar Directive is somewhat more limited than the exemption under the Patents and Designs Act (Chapter 417 of the Laws of Malta). It is still not clear to what extent Malta’s ratification of the Unified Patent Court Agreement has affected this regime.
- 21.
Chapter 417 of the Laws of Malta, Article 27(6).
- 22.
Some of the major players have production plants in Malta. Examples are Actavis (even Watsons had a plant prior to the acquisition), Baxter, Cardinal Health and Siegfried. The manufacture of originator or generic medicinal products in Malta requires a licence in terms of the Manufacture and Importation of Medicinal Products for Human Use Regulations (Subsidiary Legislation 458.36 of the Laws of Malta).
- 23.
Melita Marine Limited et v Darmanin Kissaun, First Hall Civil Court (8 July 2009) [Application No. 639/05JRM] related to maritime; Mifsud v Dalli et, First Hall Civil Court (23 June 2009) [Application No. 942/2008] related to construction; Melita Marine Limited et v S&D Yachts Limited, Court of Appeal (24 February 2012) [Appeal Application No. 1224/2005/1] related to maritime.
- 24.
Melita Marine Limited et v Darmanin Kissaun, First Hall Civil Court (8 July 2009) [Application 639/05JRM].
- 25.
See http://health.gov.mt/en/pharmaceutical/Pages/formulary/formulary.aspx. Accessed 23 September 2016.
- 26.
Availability of Medicinal Products within the Government Health Services Regulations (Subsidiary Legislation 458.31 of the Laws of Malta), Regulation 5(2).
- 27.
V. Bugeja, ‘Medicines: mere generic facts’ in Journal of the Malta College of Pharmacy Practice 13 2007, 42. http://www.mcppnet.org/publications/ISSUE13-9.pdf. Accessed 23 September 2016.
- 28.
As has been noted elsewhere, parallel importation of centrally authorised products tends to impose high expenses for small operators.
- 29.
Medicines Act, Article 80(2).
- 30.
Novartis AG v Immobilier France Ltd, First Hall Civil Court (2 October 2012) [Application No. 488/2010].
- 31.
King.com Limited v TeamLava LLC, First Hall Civil Court (30 March 2015) [Warrant no. 224/2015].
- 32.
ibid.
- 33.
Within the context of the discussion in Sect. 10.3 above, the List contains a description of the active ingredient of the medicinal product rather than its proprietary name, unless exceptional circumstances required otherwise where patient safety is compromised. See Article 5 (2) of the Availability of Medicinal Products within the Government Health Services Regulations, Subsidiary Legislation 458.31 of the Laws of Malta.
- 34.
Article 2 (1) of the Availability of Medicinal Products within the Government Health Services Regulations, Subsidiary Legislation 458.31 of the Laws of Malta.
- 35.
https://health.gov.mt/en/cpsu/Pages/Home.aspx. Accessed 23 September 2016.
- 36.
See Case C-205/03 P Fenin (11 July 2006) ECLI:EU:C:2006:453, pts 25-26 a contrario sensu.
- 37.
P. Aquilina, ‘The Malta Commission for Fair Trading upheld as abusive the commercial practices of a private hospital and quashes subsidiary legislation stipulating prices of blood products supplied to private medical undertakings (Malta’s National Blood Transfusion Service)’ e-Competitions N° 16288 October 2006. http://www.concurrences.com/IMG/_article_PDF/article_16288.pdf. Accessed 23 September 2016.
- 38.
Case C-138/11 Compass-Datenbank (12 July 2012) ECLI:EU:C:2012:449.
- 39.
Wholesale Distribution and Brokering of Medicinal Products and Active Substances Regulations, Subsidiary Legislation 458.37 of the Laws of Malta.
- 40.
Parallel Importation of Medicinal Products Regulations, Subsidiary Legislation 458.40 of the Laws of Malta.
- 41.
It is assumed that these medicinal products are already covered by a marketing authorisation obtained in Malta or in another EU Member State.
- 42.
Although it was reported that price monitoring exercises are conducted in C. Farrugia & K. Savvas, ‘Pricing of Medicinal Products: Considerations in a Small Member State’ in Journal of the Malta College of Pharmacy Practice (Issue 15, 2009), 30. More recently,
- 43.
O. Vella, ‘Reductions in medicine prices’ in Times of Malta (12 April 2015). http://www.mccaa.org.mt/loadfile/947ee785-bb87-4c5c-b6a3-909a0bfa96ef. Accessed 23 September 2016.
- 44.
Specifically, its Health Care Business and Pharmaceuticals Manufacturers Business Sections. See http://www.maltachamber.org.mt/. Accessed 23 September 2016.
- 45.
See http://www.mccaa.org.mt/loadfile/22fa2286-add2-479a-aaa2-125d6a485c7a. Accessed 23 September 2016.
Author information
Authors and Affiliations
Corresponding author
Editor information
Editors and Affiliations
Rights and permissions
Copyright information
© 2017 Springer International Publishing AG
About this chapter
Cite this chapter
Mifsud-Bonnici, C. (2017). Malta. In: Kobel, P., Këllezi, P., Kilpatrick, B. (eds) Antitrust in Pharmaceutical Markets & Geographical Rules of Origin. LIDC Contributions on Antitrust Law, Intellectual Property and Unfair Competition. Springer, Cham. https://doi.org/10.1007/978-3-319-55813-4_10
Download citation
DOI: https://doi.org/10.1007/978-3-319-55813-4_10
Published:
Publisher Name: Springer, Cham
Print ISBN: 978-3-319-55812-7
Online ISBN: 978-3-319-55813-4
eBook Packages: Law and CriminologyLaw and Criminology (R0)