AG’s Opinion – Licensed and Unlicensed Medicines May Fall Within the Same Relevant Product Market

Yesterday’s Opinion from Advocate General Saugmandsgaard Øe (AG) in Hoffmann-La Roche vs Autorità Garante della Concurrenza e del Mercato takes the position that licensed and unlicensed pharmaceutical products used for the same indication may fall within the same relevant product market. The Italian Council of State (ICS) referred a number of questions to the EU Court of Justice (CJEU) in March 2016 in the context of the appeal against the Italian Competition Authority’s (ICA) decision that Roche and Novartis reached an illegal market sharing agreement in the market for ophthalmic drugs for serious vascular eyesight conditions.

Background

Avastin (Genentech’s drug licensed to Roche) was approved for certain oncology indications. However, doctors started prescribing unlicensed Avastin to treat vascular eye conditions. Genentech’s Lucentis (licensed to Novartis), indicated for the treatment of certain vascular eye conditions, used a very similar active ingredient.

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EU Vote on First Borderline Decision Confirms: Cranberry Products Are Not Medical Devices

This article was originally posted on our sister blog Inside Medical Devices

The EU Regulatory Committee on Medical Devices recently voted in favor of the European Commission’s draft decision on the classification of cranberry products (the “Cranberry Decision”).  In essence, the Cranberry Decision provides that cranberry products intended to prevent or treat cystitis and that have a principal intended action based on proanthocyanidins (“PACs”) do not fall within the definition of medical devices.  The European Commission adopted its draft decision based on Article 13(1)(d) of Directive 93/42/EEC (the “Medical Devices Directive”).

The vote comes more than one year after the Commission prepared a draft decision, in February 2016 (see our analysis of that draft decision here).  The formal adoption and publication of the Cranberry Decision are expected later this summer.  This article first briefly summarizes the regulatory context of EU borderline issues.  It then explains what triggered the decision, analyzes its content, and provides a brief outlook on what is coming next. Continue Reading

Exploring the EU Horizon for Pharma

The EU pharmaceutical industry landscape is in significant flux. There are many pressures to provide new therapies and to make them available more early and for as many qualifying patients as possible. In that context, the industry model and the role of exclusivity rights as a tool to stimulate innovation are being discussed. At the same time, discovering and developing new products is more complex and requires a collaborative effort. This happens against the background of new rules on medical devices and the protection of personal data, which are, for instance, relevant in assessing clinical effectiveness and relying on real world evidence.

Three members of the Covington European Life Sciences team will be speaking on these topics at the EU Pharmaceutical Law Forum being held in Brussels on 16-18th May. Continue Reading

EU Medical Devices Regulation Series: Potential for Easing Borderline Determinations?

This article was originally posted on our sister blog Inside Medical Devices

Earlier this week, in a plenary vote, the EU Parliament endorsed the texts of the Regulation on Medical Devices (the “Regulation”—latest version available here) and the parallel Regulation on In-Vitro Diagnostic Medical Devices (the “IVD Regulation”—latest version available here).  This presents a good opportunity to have a closer look at one of the essential questions of the revision of the medical device rules, namely, whether the scope of the Regulation changes in comparison to that of the main Medical Devices Directive 93/42/EEC (the “Directive”).  We examine below the changes to the definition of a medical device and whether the Regulation affects borderline determinations.

As discussed in our earlier post, the borderline between medical devices, medicinal products, cosmetics and foods or food supplements is often blurred.  The Regulation sheds some additional light on the definition of a medical device and strengthens the Commission’s power in relation to the borderline issues.  Nevertheless, important questions continue to exist, for instance in relation to the pharmacological versus physical (or purely chemical) mode of action of a product. Continue Reading

Italian Council of State Improves Access to Investigational Medicines

Recently, the Council of State (i.e., the Italian supreme administrative court and consultative body) adopted an important advisory opinion, which allows for improved access to investigational medicines by patients in Italy.  In particular, the Council of State found that patients may be enrolled in compassionate use programmes or supplied with a medicine listed in the so-called 648 List after the product has obtained a marketing authorization, at least until the company starts to commercialize it in Italy.  The latter normally presupposes that the product is classified as subject to reimbursement.

Access to Medicines Not Authorized in Italy

There are de facto two regimes allowing patients to access investigational medicines (i.e., medicines that are not yet authorized in Italy).[1]  The first, applied in most cases, is the compassionate use regime.  The second, used in more exceptional cases, is the so-called 648 regime.  The two regimes may not be applied simultaneously.  Continue Reading

EU Medical Devices Regulation Series: Interpreting the “Industrial Scale” Concept

This article was originally posted on our sister blog Inside Medical Devices

The term “industrial scale” appears twice in the draft EU Medical Devices Regulation (“MD Regulation”) in relation to so-called “in-house devices.” The term equally appears in the draft in-vitro diagnostic medical devices (“IVD”) Regulation.

To provide perspective on the meaning of “industrial scale” and how the draft MD Regulation’s use of the term may be interpreted, this post looks at two recent judgments pertaining to medicinal products before the EU Court of Justice: Joined Cases C-544/13 and C-545/13 Abcur (link here) and Case C-276/15 Hecht-Pharma (link here). Although there are evidently major differences between the medical device and medicines regulatory regimes, these judgments nevertheless provide useful guidance to interpret the notion “(non-)industrial scale” under the draft MD Regulation. Continue Reading

UK CMA Imposes Record Fine on Pfizer

The UK’s Competition and Markets Authority (the “CMA”) imposed a £84.2 million (€99.7 million) fine on Pfizer yesterday. In addition, the CMA also fined distributor Flynn Pharma £5.2 million (€6.1 million).  The CMA found that Pfizer and Flynn Pharma abused their dominant positions by charging excessive and unfair prices for phenytoin sodium capsules, drugs used to treat epilepsy, in the UK.  In addition to the fines, the CMA ordered both entities to reduce their respective prices within timeframes of between 30 working days and 4 months.

In September 2012, Pfizer sold the UK distribution rights for the phenytoin sodium capsules (sold until then under the brand name Epanutin) to Flynn Pharma. Flynn Pharma subsequently de-branded the drug, effectively taking it outside the price regulatory regime.  Pfizer continued to manufacture the drugs.  The CMA found that, after September 2012, Pfizer supplied the capsules to Flynn Pharma at wholesale prices that were between 780% and 1,600% higher than its previous prices to wholesalers and pharmacies.  It also found that Flynn Pharma’s prices to wholesalers and pharmacies were between 2,300% and 2,600% higher than the prices previously paid to Pfizer.  Flynn Pharma’s prices also significantly exceeded the prices charged by Pfizer (after September 2012) for the same products in other European countries. Continue Reading

Another round of upcoming amendments to the medicines laws in Germany – Clinical Trials, Advertising, Biologics and more…

On 11 November 2016, the German Parliament passed another new law amending different parts of the German Medicines Act (Arzneimittelgesetz) and the Act on Advertising for Healthcare Products (Heilmittelwerbegesetz). The law is titled “Viertes Gesetz zur Änderung arzneimittelrechtlicher und anderer Vorschriften“. The draft was deliberated in the health committee of the Federal Council (Bundesrat) on 30 November 2016 and it has become clear that the Federal Council will not object to it in its final deliberations later this month. Therefore, the new law will likely become effective at the beginning of 2017.

The new law especially amends the existing clinical trial rules so that German law will comply with the new Clinical Trials Regulation (EU) No 536/2014. The amendments  particularly affect the approval procedure for new studies and the competencies of the ethics committees and regulatory authorities. While currently, two full stand-alone approvals for a study are required (i.e., from the ethics committee and the competent authority), under the new law, certain parts of the ethics committee’s opinion may be overruled by the authority. In addition, a new federal ethics committee can be established by the regulatory authorities which would additionally lead to significant changes in the procedure. Continue Reading

Upcoming Changes to Italy’s Biosimilar Landscape

On 28 November 2016, the Italian Chamber of Deputies approved the Draft Budgetary Law of 2017.  Among other things, the Draft Law introduces new rules on the substitutability of biologics and the procurement of biosimilars.

In particular, Article 59(11) of the Draft Law provides that:

  • two products enjoy a biosimilarity relationship only where this has been established by the European Medicines Agency (EMA) or the Italian Medicines Agency (AIFA);
  • the automatic substitution of an originator biologic with its biosimilars (and between biosimilars) is not allowed;

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The Court of Justice of the EU Adopts a Broad Interpretation of the Information on Emissions into the Environment that Authorities Must Disclose to the Public

Last week the Court of Justice of the European Union (“CJEU”) upheld a broad interpretation of the concept of “information that relates to emissions into the environment” that EU and Member State authorities (e.g., ECHA, EFSA, Commission, national environmental agencies) must disclose to the public.  According to the CJEU, the information that must be disclosed does not only relate to emissions from industrial installations, and must also include data allowing the public to: (i) know what is, or may be foreseen to be, released into the environment under normal or reasonable conditions of use of a product or substance; (ii) check the correctness of the assessment of the actual or foreseeable emissions on the basis of which product or substance is authorized; and (iii) understand the effect of those emissions on the environment.   This information must be disclosed to the public, upon request, even if it may affect the commercial interests of companies.

The CJEU’s decisions will have a significant impact on all companies that are required to submit regulatory filings to access the EU market under different EU legislation (e.g., REACH, Biocides, Plant Protection Products, Fertilizers, GMOs).  These companies must now assume that much of the data they submit may not be kept confidential.

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