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The case arose from the reimbursement by the Italian authorities of medicinal products used for an indication for which they are not authorised, in circumstances where there is an alternative authorised product available. Italian law permits the reimbursement of such products “provided that the [unlicensed] indication is known and is in line with research conducted by the national and international medical-scientific community on the basis of economic and suitability considerations”. In these cases the Italian Medicines Agency (AIFA) puts in place monitoring arrangements intended to protect patient safety.

Avastin® (bevacizumab), which is licensed for administration by intravenous infusion for various oncology indications, was added to the Italian reimbursement list in 2014, for intravitreal injection in the eye for the treatment of ophthalmology conditions, on the following conditions:

  • To ensure sterility, packaging of bevacizumab in single dose syringes must be carried out solely by hospital pharmacies satisfying defined requirements and following rules to ensure the doses are properly prepared.
  • The product can be administered only by highly specialised ophthalmological departments in designated public hospitals.
  • Administration may take place only once the patient has signed an informed consent, including the scientific reasons, accompanied by adequate information about the existence of approved alternative therapies at higher cost to the Italian health service.
  • A monitoring record must be created with an adverse reactions declaration form.

Novartis Farma challenged the inclusion of Avastin® in the reimbursement list on the basis that this was incompatible with EU pharmaceutical law. In particular: (i) the general use of medicinal products “off-label”, for financial reasons, in circumstances where the suitability of the licensed product for such use has not been tested, breaches the mandatory character of a marketing authorisation (MA) under Art 6 of Directive 2001/83/EC and is incompatible with Directive 89/105/EEC (the Transparency Directive); (ii) by allowing AIFA to establish monitoring mechanisms to safeguard patient safety, Italian law permits AIFA to encroach on the role of the EMA as established by Regulation No 726/2004; and, (iii) the repackaging of Avastin® does not comply with the conditions required for the exemption under Art 3.1 of Directive 2001/83/EC to apply.

The Italian Court referred four questions to the CJEU.Continue Reading Novartis Farma SpA v AIFA

On 25 October 2018, the Court of Justice of the EU (CJEU) held in Case C-527/17 Boston Scientific that, where a medical device incorporates an ancillary drug substance, that substance will not be entitled to supplementary protection certificate (SPC) protection. That is the case even if the drug substance has been subjected to an evaluation of its safety, quality and efficacy that is analogous to the authorisation procedure for medicinal products, which are entitled to SPC protection.
Continue Reading European Court ruling on SPCs for medical devices

Last week, the CJEU gave its decision in another procurement case in the healthcare area, Case C‑413/17 Roche Lietuva UAB. The case concerned the scope of technical specifications included as part of a tender by the Polyclinic for the Dainava District of Kaunas in Lithuania. The tender set out details of the medical diagnostic equipment and materials the authority wished to procure. Roche claimed that the specifications unreasonably restricted competition among suppliers due to their high specificity, and that in reality, the specifications corresponded to the products of certain manufacturers and excluded others.

The question referred to the Court concerned the limits to the margin of appreciation of a contracting authority to set out specifications in the tender, based on the quality of testing and the value of healthcare that it needs. The Court set out a useful summary of when technical specifications can be included in a tender and the principles for applying such specifications.Continue Reading European Court clarifies use of technical specifications in healthcare tenders

Last week, the European Court of Justice gave its judgment on certain procurement questions relating to the supply of a radiopharmaceutical product, referred by the Italian Court in Case C-606/17, IBA Molecular Italy Srl. An Italian regional health authority and a public hospital were seeking to award a substantial contract to a private hospital, without conducting a public tender. They argued that as no direct consideration was provided to the hospital, and as the hospital was “classified” as part of the public healthcare system, any award constituted an agreement between public authorities to which EU law on public procurement does not apply. The European Court disagreed, and concluded that (i) public authorities cannot circumvent the EU procurement rules by awarding “funding” to an organisation in return for the provision of free products, and (ii) it was not possible to treat a “private” hospital as a public hospital in order to award contracts to them outside the EU procurement rules.

From the information available about the case, the answers to the questions referred seem straightforward and may be limited to the Italian system. However, it is nonetheless useful to have confirmation from the Court on the extent to which the provision of healthcare falls within the EU procurement regime.Continue Reading European Court clarifies the application of procurement rules to healthcare

The next Future Pharma Forum will be on 27 September: Implications of Recent EU and UK Court Decisions in the Pharmaceutical Sector

Emily MacKenzie, Barrister at Brick Court Chambers, will join us to recap on how challenges to pharmaceutical decisions may be brought to the European and domestic courts. Emily will provide a summary…

On the morning of 25 July 2018, the Court of Justice of the European Union (the CJEU) handed down judgment in Case C-121/17 Teva UK and Others v Gilead concerning the validity of Supplementary Protection Certificate (SPC) protection for Gilead’s combination HIV treatment TRUVADA (tenofovir disoproxil and emtricitabine). The CJEU held that an SPC can only be granted for a product if, in the basic patent on which the SPC is sought, that product “is either expressly mentioned in the claims of that patent or those claims relate to that product necessarily and specifically.” It is for the English High Court, as the referring court, to determine whether that test is met by Gilead’s patent in this case; however, the CJEU stated (on the basis of the information provided by the referring court) that it does not seem possible that the combination of tenofovir disoproxil and emtricitabine necessarily falls under the invention covered by Gilead’s patent.
Continue Reading CJEU rules on SPCs for combination products

Software can be considered a medical device under EU law. Although guidance has been issued by the European Commission and national authorities to assist in legal classification, factors or criteria that are considered as relevant in such guidance have not been validated by European or national courts. The recent decision of the Court of Justice of the European Union (CJEU) on legal classification of software medical device is therefore instructive.

The European Court’s first decision on the classification of software in the context of medical devices legislation

On 7 December 2017, the CJEU issued its judgment in Case C-329/16. The CJEU agreed with the Advocate General’s opinion (discussed in our previous Advisory), and held that software can be classified as a medical device under EU law if the software has at least one functionality that allows the use of patient-specific data to assist the physician in prescribing or calculating the dosage for treating the underlying condition. It does not matter whether the software acts directly or indirectly on the human body. The decisive factor is whether the software is specifically intended by the manufacturer to be used for one or more medical objectives specified in Article 1(2) of Directive 93/42/EEC (the Medical Devices Directive), including the diagnosis, prevention, monitoring, treatment or alleviation of disease.Continue Reading Classification of software as a medical device

On 20 December 2017, the Court of Justice of the European Union (CJEU) confirmed that the term of a supplementary protection certificate (SPC) can be corrected to bring it into line with CJEU case law at any time before expiry of the SPC.

Following on from the decision in Seattle Genetics (C‑471/14) in 2015, which provided welcome clarity on which date should be used as the date of the first marketing authorisation (MA) for the purposes of calculating the duration of an SPC, this week’s decision should drive consistency in the application of Seattle Genetics by national patent offices across the EU. In Incyte (C‑492/16), the CJEU has ruled that an SPC holder can apply to rectify the duration of an SPC to bring it into line with Seattle Genetics at any time before expiry of the SPC, even if the period for appealing the decision under national legislation has passed.Continue Reading CJEU confirms that SPC term calculated using “incorrect” MA date can be rectified at any time before expiry

In October, we reported that the oral hearing before the Court of Justice of the European Union (CJEU) took place in Case C-557/16 relating to the role of the Concerned Member States (CMS) in the Decentralised Procedure (DCP).

The Opinion of Advocate General Bobek has now been handed down. Although the AG takes no position on whether Ribomustin or Levact should have been used as the reference medicinal product, or when the applicable regulatory data protection (RDP) period started running, he opines that the CMS may raise issues as to RDP during the assessment phase and are co-responsible for the documents approved in that procedure. However, once agreement has been reached, CMSs cannot unilaterally revisit that decision. After authorisation, the courts of CMSs are competent to review the determination of the national competent authority.Continue Reading AG opines that CMSs are co-responsible for MAs granted under the DCP