The Commission’s Proposal on Health Technology Assessment – Will the EU Member States Accept its Mandatory Provisions?

By Lucas Falco on Posted in Food & Drug Regulatory, Medical Devices, Medicinal Products

This article was originally posted on our sister blog Global Policy Watch

Introduction

Health technology assessment (“HTA”) is a multidisciplinary assessment process that seeks to evaluate the added therapeutic value of health technologies (i.e., drugs, certain medical devices, medical treatments including surgical procedures, and measures for disease prevention and diagnosis) based on both clinical and non-clinical elements.  Until now, HTA has strictly fallen in the purview of EU Member States; they have cooperated among themselves in this field for more than 20 years on a purely voluntary basis.  This has led to initiatives such as EUnetHTA, which is a network of national HTA bodies, and its various Joint Actions.  Article 15 of the Cross-Border Healthcare Directive (Directive 2011/24) also provides for that national bodies responsible for HTA should cooperate on a voluntary basis.  Gradually, these various actions have developed common criteria for the performance of HTA at national level.  For example, the last “Joint Action 3” of EUnetHTA seeks to define common assessment methodologies, develop common ICT tools, and conduct and produce joint clinical assessments and HTA reports.

EU Member States have acknowledged the significant role that HTA plays and called on the European Commission to continue to support such initiatives (see, e.g., Council conclusions of December 6, 2014, on innovation for the benefit of patients).  However, in a resolution of March 2, 2017, the European Parliament went a step further and called on the Commission to propose legislation on health technology assessment at the EU level to provide transparent and harmonized criteria to evaluate the added therapeutic value of drugs and other health technologies. Continue Reading

German government has started enforcement of the Nagoya Protocol and reviews compliance of pharmaceutical companies

By Dr. Dr. Adem Koyuncu and Bart Van Vooren on Posted in Food & Beverage, Food & Drug Regulatory, Medicinal Products, Pharmaceutical companies

The “Nagoya Protocol on Access to Genetic Resources and the Fair and Equitable Sharing of Benefits Arising from their Utilization to the Convention on Biological Diversity” is an international agreement which aims at sharing the benefits arising from the utilization of genetic resources in a fair and equitable way. It entered into force on 12 October 2014.

The Nagoya Protocol imposes a complex set of multi-jurisdictional compliance obligations on businesses active in the pharmaceutical, food, cosmetics and other life science sectors. It now has more than 100 contracting parties, including the EU. The key legal source in the EU is Regulation (EU) No. 511/2014 on compliance measures for users from the Nagoya Protocol on Access to Genetic Resources and the Fair and Equitable Sharing of Benefits Arising from their Utilization in the Union. Continue Reading

German court allows pharma company public promotional statements about Rx-drug to counter a “shitstorm” – a trend also for the rest of the EU?

By Dr. Dr. Adem Koyuncu on Posted in Competition, Food & Drug Regulatory, Medical Devices, Medicinal Products

By Dr. Dr. Adem Koyuncu, Covington & Burling LLP

In the EU, drug companies are not allowed to publicly promote prescription-only medicines. As courts also apply a broad interpretation of the term “promotional”, nearly all public statements that mention a prescription drug are likely to be qualified as illegal advertising. In certain circumstances, this may be the case even if no drug is mentioned.

But what should a drug company do if false statements about its product are distributed? What is allowed in case of a so-called shitstorm? What can the company do to counter negative public statements about its drugs by HTA bodies or other institutions of the healthcare system?

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Commission publishes draft rules on country of origin/place of provenance indications for primary ingredients

By Lucie Klabackova and Brian Kelly on Posted in Food & Beverage, Food & Drug Regulatory

On 4 January 2018, the European Commission published a draft implementing regulation laying down rules for the application of Article 26(3) of Regulation (EU) N° 1169/2011 of the European Parliament and of the Council on the provision of food information to consumers (“FIC”), as regards the rules for indicating the country of origin or place of provenance of the primary ingredient of a food where different to that given for that food (hereafter “Draft Implementing Regulation”).

Permitted Indications

Article 2 of the Draft Implementing Regulation supplements Article 26(3) of the FIC and sets out different options of indicating the country of origin or the place of provenance of a primary ingredient which is not the same as the given country of origin or the given place of provenance of the food. The options include:

  • A simple indication of “EU”, “non-EU” or “EU and non-EU”;
  • Member State(s) or third country(ies);
  • The country of origin or place of provenance in accordance with specific Union
  • provisions applicable for the primary ingredient(s) as such;
  • Regions or any other geographical area within Member State(s)/third country(ies);
  • FAO fishing areas, sea or freshwater body.

In relation to the last two options, these need to be either defined as such under public international law or well understood by normally informed average consumers. Food business operators (FBOs) also have the option to inform consumers by using the following or similar statement: “(name of the primary ingredient) do/does not originate from (the country of origin or the place of provenance of the food)”.

Presentation Requirements

Additionally, Article 3 lays down presentation requirements for the country of origin or the place of provenance indications and provides that the font size shall not be smaller than the minimum font size under FIC (currently 1.2 mm x-height or 0.9 mm x-height for small packages with the largest surface area of less than 80 cm2). Furthermore, if FBOs choose to provide this indication in words, then the font size needs to be at least 75% of the x-height of the indication of the country of origin or the place of provenance of the food. Indications given in a non-scriptural form shall appear in the same field of vision as the indication of the country of origin or the place of provenance of the food.

Scope and Date of Application

The Draft Implementing Regulation does not apply to protected geographical indications and registered trademarks. Stakeholders have four weeks to provide their views on the Draft Implementing Regulation and the feedback period ends on 1 February 2018. The Draft Implementing Regulation shall apply from 1 April 2019 and the transitional measures allow for foods placed on the market or labelled prior to 1 April 2019 to be marketed until the stocks are exhausted.

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

By Jennifer Boudet and Miranda Cole on Posted in Competition, Medicinal Products, Pharmaceutical companies

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

By Charlotte Ryckman on Posted in Food & Drug Regulatory, Medical Devices, Medicinal Products

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

By Peter Bogaert, Kristof Van Quathem and Lucinda Osborne on Posted in Food & Drug Regulatory, Healthcare system, Privacy & Data Security

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?

By Charlotte Ryckman on Posted in Medical Devices

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

By Luca Tosoni on Posted in Food & Drug Regulatory, Medicinal Products

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

By Bart Van Vooren on Posted in Food & Drug Regulatory, Medical Devices

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

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