Following the UK’s departure from the EU, the UK Government has been exploring ways to leverage its new regulatory freedoms. In particular, the life sciences sector has been a key Government priority. As early as January 2021, for example, the Government granted the MHRA powers to fast-track approvals for innovative medicines. More recently, two reports
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?
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 EU Vote on First Borderline Decision Confirms: Cranberry Products Are Not Medical Devices
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). 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 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 Another round of upcoming amendments to the medicines laws in Germany – Clinical Trials, Advertising, Biologics and more…
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;
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 Medicines Agency (EMA) has recently published for public consultation its draft guideline on clinical development of fixed combination medicinal products (Draft Guideline), which is intended to replace CHMP/EWP/240/95 Rev. 1 (Existing Guideline). The Draft Guideline applies to fixed combination medicinal products containing two or more active substances within a single pharmaceutical form. The active substances may be known active substances or substances that have yet to be authorised in the EU.…
Continue Reading New Draft EMA-Guideline On Clinical Development Of Fixed Combination Medicines