Following the federal election in September 2021, Germany will soon be led by a new three-party coalition, the so-called “traffic light coalition”, composed of the Social Democratic Party (SPD), the Liberal Democrats (FDP) and the Green Party (Die Grünen). This new federal government led by the new chancellor Olaf
On 6 May 2021, the European Commission published its “EU Strategy on COVID-19 Therapeutics” (the “Strategy”). With the vaccination programme now under way, the EU is shifting focus towards the development, approval and procurement of COVID-19 therapeutic products. The Commission intends to build on the experience from the EU vaccines strategy. In particular, the aim is to have three new therapeutics available by October 2021 and possibly two further products by the end of the year.
The Strategy touches on a number of key areas for both biotechnology and pharmaceutical companies operating in the space:…
Continue Reading European Commission outlines Strategy on COVID-19 Therapeutics
On 20 March 2020, the European Medicines Agency (EMA) published Guidance on the Management of Clinical Trials during the COVID-19 (Coronavirus) pandemic (the Guidance). The EMA jointly developed the Guidance with working groups from the European Commission and the national Heads of Medicines Agency (HMA).
The Guidance provides information on changes and protocol deviations that…
This article was originally posted on our sister blog Global Policy Watch
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 The Commission’s Proposal on Health Technology Assessment – Will the EU Member States Accept its Mandatory Provisions?
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 government has started enforcement of the Nagoya Protocol and reviews compliance of pharmaceutical companies
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?
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.…