by Dr Anthia A Zammit

Article 126a of Directive 2001/83 states that “In the absence of a marketing authorisation or of a pending application for a medical product authorised in another Member State in accordance with this Directive, a Member State may for justified public health reasons authorise the placing on the market of the said medicinal product.”. One third of all medicines registrations in Malta are authorised through Article 126a. However, the Public Contracts Review Board (PCRB or the Board) decision of 18 February 2020 has ushered in a reviewed and improved Article 126a marketing authorsation (MA) process this same year, starting on 1 October 2020.  

The PCRB’s Case 1412 regarding the Tender CT2340/2018 for the Supply of Human Biosynthetic Insulin Preparations for Injection in Cartridges  decided on the objections against the Central Procurement and Supplies Unit (CPSU or Contracting Authority) filed by the appellants who argued that the tender awarded to VJ Salomone Pharma Limited for the procurement of Gensulin was illegally awarded. Arguments about patient safety centered around the bio-similarity of the insulin (Gensulin) to be procured under this tender, and the fact that the authorisation to place the product on the Maltese market was based on Article 126a and the product was not authorised by either the European Medicines Agency (EMA) through a centralised procedure or by the US Food and Drug Administration (USFDA).

The appellants, Charles de Giorgio Limited, claimed that: the product offered by the preferred bidder is only approved on a national basis in Poland and is not approved by the European Medicines Agency (EMA), the CPSU did not carry out the necessary research and receive advice from specialists to ensure patients’ safety, and the product is not bio-equivalent to the original product and the product currently prescribed through the Maltese public healthcare service, but is bio-similar. 

The CPSU maintained that the preferred bidder’s product met all the requirements stipulated in the tender document and is the cheapest. In its testimony, the Medicines Authority explained that the smallest EU member states tend to have the most Article 126a authorisations due to medicines availability issues. Products authorised using the provisions of Article 126a are placed on the market on the basis of the same laws, guidelines, and rules as any other authorisation and on this basis the Board was “comfortably satisfied” that the product Gensulin was “properly registered and can be placed on the market in Malta”.

This Board stated that its remit is assessment of whether the product conforms with all the regulatory requirements and safeguards patients’ safety. In assessing whether the evaluation process was fair and transparent, the Board noted that the appellants did not dispute the technical specifications of the tender. The Board, relying on expert witness testimony, was “comfortably assured” that the product ‘Gensulin’ is safe, and that no negative results had been reported about the product since its authorisation in Poland. In upholding the Contracting Authority’s decision, the Board stated that the “safety factor is inbuilt” in the tender’s technical specifications and that Gensulin is compliant with those specifications. The Board confirmed that the Article 126a authorisation allows a EU member state such as Malta to base its licence (marketing authorisation) to place the product on the Maltese market on the marketing authorisation granted by another EU member state.

The medicines marketing authorisation landscape in Malta might see some significant change in the future.  From 1 October 2020, the new Article 126a application process asks the applicant to provide detailed public health justifications for choosing this route.  The Medicines Authority now states that “if a product is eligible to be authorised through the established legal routes for marketing authorisation, the Medicines Authority has the right to refuse the application under the Article 126(a) legal basis”. Applicants are asked to consider all other possible routes for registration, effectively leaving Article 126a as a last resort. Article 126a authorisations are now valid for three years, and validity can only be extended if the product has been procured by a government tender beyond the validity of the authorisation, to ensure that the public procurement obligation is fulfilled.

The Medicines Authority has established an Advisory Committee with the purpose of discussing Article 126a applications. The Committee discusses the public health reason provided by the applicant and/or reasons provided “for not applying for a marketing authorisation through the established registration routes”. The list of pending Article 126a authorisations are now published on a regular basis. Third parties with a direct interest in a product assessed for an Article 126a authorisation may direct their concerns to the Medicines Authority to be discussed at the Committee.  

Following the recent change in policy, many medicinal products will find their cost-benefit analysis completely re-dimensioned once their original Article 126a authorisations expire as they will not be easily renewed. Article 126a applications can be based on a simple national procedure in a country of source. A “day zero” procedure would require changing to an MRP in the source country, and the cost of that in the source country could be significantly higher. Article 126a authorised products do not have to upload pack data in the Malta Medicines Verification System (MaMVS). A MRP authorised medicinal product would have to upload numbers so that will increase data upload costs, and cause other logistical issues.  

The CPSU in Malta purchases Article 126a authorised medicinal products and has a wholesale dealer’s license. Following the appeal to tender CT2340/2018, companies may well challenge the Article 126a authorisations directly.  Whether or not Article 126a authorisations survive long term depends on whether MAHs of competing medicinal products are prepared to challenge national competent authorities on the concept of public health need.  With limited and overstretched public health budgets and heavy public health needs and entitlements to cover, public procurement is designed to obtain the most volume for the expenditure.  This was an important criterion when Article 126a of Directive 2001/83 was drafted. The far greater costs of meeting the needs of patients in an EU member state if an unreliable Article 126a authorisation holder is unable to comply with its obligations under Article 81 of Directive 2001/83/EC and its responsibilities under Delegated Regulation 2016/161 (as the legal entity responsible for placing the product on the market) could tip the balance.  

Dr Anthia A Zammit is an advocate admitted to the practice of law in Malta (EU) and a licensed legal consultant in the State of New York (US).  Dr Zammit has extensive experience in European law concerning the regulation of medicinal products (pharmaceuticals and biologics) and medical devices.  www.anthiazammit.com

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