Conditional approvals are valid for one year and can be renewed annually. On 21 July 2022, the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) adopted a positive opinion recommending the granting of a conditional marketing authorisation for teclistamab (Tecvayli) for the treatment of adult patients with relapsed and refractory multiple myeloma who have received at least three prior therapies. As with any medicine, if new evidence shows that the benefits of the medicine no longer outweigh its risks, the EMA may take regulatory action, such as suspending or withdrawing the marketing authorisation. Tecvayli has been supported by the EMA`s PRIority Medicines (PRIME) programme, which provides early and improved scientific and regulatory support for medicines that have particular potential to address patients` unmet medical needs. The EMA`s CHMP reviewed the marketing authorisation application on an accelerated schedule to allow patients faster access to this medicine. In Europe, the authorisation of orphan medicinal products is centralised by the European Medicines Agency (EMA). There are different types of marketing authorisations that give access to EU marketing and are available to companies or universities developing new medicines to apply. Full marketing authorisation is the standard type that requires a full amount of information on the clinical benefit and safety of the medicinal product in question. For rare diseases, it can be difficult to obtain the “standard amount” of data due to the limited number of patients. Typically, this approval pathway does not lead to standard approval. This document does not contain a value judgment on the effectiveness of the Covid-19 vaccine, nor should it be interpreted as discrediting the important role of vaccine manufacturers, the European Medicines Agency (EMA) and the European Commission in the vaccination campaign. It focuses solely on an assessment of the legal implications of the Commission`s decision to grant conditional marketing authorisation (CMA) for Covid-19 vaccines and aims to promote a legal debate on the conditions and impacts of public health interventions in an atmosphere of risk and uncertainty. It applies legislation, case law and science on the precautionary principle to assess the granting of AMC for Covid-19 vaccines.
(1) www.ema.europa.eu/en/human-regulatory/marketing-authorisation/conditional-marketing-authorisation The EMA report also shows that it takes an average of four years to generate the additional data needed to convert an AMC into a standard authorisation. Building on 10 years of experience with the CMA Regulation, the EMA report also identifies a number of potential areas for improvement, including forward planning of MACs and early dialogue with the EMA to support the generation of high-quality data and the timely discussion of additional post-approval studies and their feasibility. The CHMP opinion is an intermediate step on Tecvayli`s path to patient access. The opinion will now be forwarded to the European Commission for a decision on an EU-wide authorisation. Once the marketing authorisation has been granted, decisions on price and reimbursement are taken at the level of each EU Member State, taking into account the potential role or use of that medicine in that country`s national healthcare system. “In the biggest global health crisis in a century, we decided to work together to ensure that every region in Europe has equal access to a life-saving vaccine.” 67 With these words from the 2021 State of the Union address, the President of the European Commission, Ursula von der Leyen, highlighted the significant efforts made by the EU institutions and Member States to ensure the European Union`s access to COVID-19 vaccines. Population. However, she acknowledged that “the speed of events and the scale of the challenges are sometimes difficult to grasp”.68 One of the main challenges is the trade-off between the need to deliver vaccines quickly by accelerating their development and approval, and the obligation to ensure their quality, safety and efficacy in accordance with EU law. In response to this compromise, the European Commission – on the positive recommendation of the EMA – granted an AMC for Covid-19 vaccines that meet the criteria of the current regulation. Detailed recommendations for the use of this medicinal product are described in the summary of product characteristics published in the European public assessment report and made available in all official languages of the European Union after the granting of the marketing authorisation by the European Commission.
