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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 Italian Council of State Improves Access to Investigational Medicines

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;


Continue Reading Upcoming Changes to Italy’s Biosimilar Landscape

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.


Continue Reading 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

Recently, the Italian Medicines Agency (AIFA) has published a new Concept Paper on Biosimilars.  The Concept Paper outlines the regulatory status of biosimilars in Italy as well as their importance for the Italian healthcare sector.

The new Concept Paper constitutes a revision of AIFA’s Position Paper on Biosimilars of 13 May 2013.  Overall, the Concept Paper does not differ significantly from the Position Paper of 2013.  In fact, both Papers indicate that it is for the physician to decide on a case-by-case basis whether to treat a patient with a biosimilar or with the innovative biologic.  They also exclude the automatic substitution between biosimilars and their originators.
Continue Reading Italian Medicines Agency Publishes New Concept Paper on Biosimilars

On 30 June 2016, the TAR Lazio, a lower Italian administrative court, found that all non-prescription medicines may be advertised to the public.  This ruling is of particular importance as until now the Italian Ministry of Health has interpreted the Italian medicines legislation as allowing the advertising to the public only of Over-the-Counter (OTC) products.

The Italian Medicines Agency (AIFA) has announced that, as of 22 July 2015, it makes available on its website the Public Assessment Reports (PARs) of medicinal products authorised in Italy through the national procedure.

For the medicines authorised from 2015 onwards, AIFA will publish the full PARs together with a summary understandable to a lay person.  While for the medicines authorised before 2015, AIFA will only publish a summary of the PARs.  All PARs will be published after redacting all commercially confidential information.
Continue Reading Italian Medicines Agency Publishes Public Assessment Reports of Medicines Authorised Through the National Procedure

The European Commission has launched a public consultation on possible EU measures to increase the transparency of nanomaterials on the European market.  The consultation is the first step of a Commission drafting procedure that is likely to end in a proposal for a Regulation on an EU Nano-Registry that the Commission could formally present by Spring 2015.

The Commission’s consultation aims at gathering the views of the public on the currently available information on nanomaterials on the market, whether the information available is sufficient to guarantee the safe use of nanomaterials and products containing them and informed consumer choice, and the different options to address any lack of information.  The consultation will contribute to the preparation of an impact assessment of a possible future Commission proposal.
Continue Reading The European Commission Launches a Public Consultation on a EU Nano-Registry

In a move that illustrates a continued political will to step up its enforcement powers, the European Chemicals Agency recently sent out REACH Article 36 letters to 46 companies that according to ECHA failed to correct their registration dossiers of intermediate substances.  Under the EU REACH Regulation, intermediates are subject to less burdensome registration substances than regular substances.  In its letters, ECHA requests registrants to provide information on the volumes of their substances covered by uses that ECHA considers are inconsistent with the REACH Regulation’s definition of “intermediate” or its strict conditions of use.

By requesting the information on volume of the substances, the letters intend to force registrants to update their registration dossiers. This can be done either by  registering the substances in full, amending their reported uses or submitting the requested information on volume.  Where the company provides the requested volume information, ECHA will start a compliance check against them for those volumes.  The letters also warn that ECHA will invite national enforcement authorities to take follow up actions against those companies that fail to act in response to ECHA’s Article 36 letters.
Continue Reading ECHA Steps Up its Enforcement Powers Under the REACH Regime

The Spanish Ministry of Health has published a draft Royal Decree on Clinical Trials, which the Spanish government is expected to adopt by the end of this year.  Once adopted, the new Royal Decree will replace Royal Decree 223/2004 on Clinical Trials and will regulate all clinical trials with medicines and medical devices in Spain.

Among other changes, the draft Royal Decree would introduce the following:

EMA has published a draft guideline on the use of phthalates as excipients in human medicinal products. The guideline establishes new Permitted Daily Exposure (“PDE”) values for the following phthalates that are among the most commonly used as excipients in medicinal products:

  • dibutyl phthalate: 0.01 mg/kg/day
  • diethyl phthalate: 4 mg/kg/day
  • polyvinyl acetate phthalate: 2 mg/kg/day

The guideline also concludes that data currently available for cellulose acetate phthalate and hydroxypropyl methylcellulose acetate phthalate do not indicate that their presence in human medicinal products constitutes a potential risk for human safety.
Continue Reading EMA Publishes Draft Guideline on the Use of Phthalates in Medicines