On 10 April 2024 the plenary assembly of the European Parliament adopted the results of the negotiations reached with the European Council in January 2024 on revising the EU’s water management and urban wastewater treatment standards. The Council needs to formally approve the agreement before it can enter into force. The new legislation will greatly impact the pharmaceutical and cosmetic sectors, as a result of the introduction of the extended producer responsibility (EPR) for medicinal products for human use and cosmetic products. EPR is intended to cover the costs of quaternary treatm ..read more

The European Commission released in April 2024 its proposals for the European biotechnology and biomanufacturing sectors. Actions are based on the identified barriers and challenges still to be solved, among which are these are research and technology transfer, regulatory complexity, access to finance, skills, value chain obstacles, intellectual property, public acceptance and economic security. Among the more significant measures impacting health biotechs, the Commission should launch a study to investigate the EU’s position compared to other global leaders in emerging biotechnology generat ..read more

The roadmap for the revision of European pharmaceutical legislation saw the EU Parliament, meeting in plenary session on 10 April, approve by a large majority a series of amendments to the Commission’s initial proposal that, in fact, appear to have largely accommodated the demands of the innovator pharmaceutical companies. The proposal for a directive was approved by 495 votes in favour, 57 against and 45 abstentions, the proposal for a regulation by 488 votes in favour, 67 against and 34 abstentions (link to the proposal for a new code for medicinal products for human use and link to the pr ..read more

So-called drug repurposing has taken hold in recent years as a development process aimed at giving new life for new indications to drugs that have been on the market for some time and are often off-patent. On the occasion of the first conference on drug repurposing, held at the beginning of March in Barcelona, EFPIA published a position paper highlighting some important elements, from an innovator industry perspective, to optimise drug repurposing activities. Repurposing activities should be increasingly supported in the future by the ability of new artificial intelligences to select the mos ..read more

The Commission published its proposal for the revision of the Variation regulation for medicines, as a part of the EU’s Pharmaceutical Strategy for Europe. The final objective is to adapt the current system for variations to the evolving reference framework, to make it more efficient, reduce administrative burdens and better respond to scientific and technological advances. MAHs are responsible for ensuring that each medicine remains compliant throughout its lifecycle.  Variations to the initial authorisation can refer to administrative details, such as a change in company address ..read more

The European Parliament adopted on 28 February 2024 in first reading its position about Unitary supplementary certificates (SPCs) for medicinal products and pesticides. The final phase of negotiations with the European Council, representing member states, should occur after the June elections, according to the Parliament. The Unitary SPC should add 5 years to the protection conferred by the original patent, complementing the Unitary patent system. Protection would cover all countries part of the European patent system. Applications for the unitary SPCs should be submitted at the European Uni ..read more

The Data Analysis and Real World Interrogation Network DARWIN EU has reached twenty partners (public or private institutions) from 13 European countries. The Network aims to generate real-world evidence (RWE) from sources such as hospitals, primary care, health insurance, registries and biobanks to support regulatory activities of EMA’s scientific committees and national regulators in the EU. The current capacity of the DARWIN EU network refers to data from approx. 140 million patients across Europe, which are converted into a common data model. Data are stored and analysed locally to ensure ..read more

Data presented by EuropaBio highlight the status of the biotech and biomanufacturing sector in relevant competitor countries (i.e. the US, China, India and Japan). The US has a higher number of biotech companies compared to Europe (8,000 vs 4,500), and a  much greater access to funding (3,557 vs 1,558 companies receiving funding between 2015 and 2021). Targets to five years include the expansion of biomanufacturing capabilities to produce at least the 25% of APIs for small molecule drugs needed in the US. The improved economic prosperity and health consciousness of the Indian population ..read more

EFPIA is among the twenty-six industry associations that have signed a document calling on the European Commission to deepen the EU Single Market. A target deemed fundamental in order to better face competition from countries such as the US and China. According to the document, current actions focused on mapping strategic dependencies, anticipating vulnerabilities, beefing up autonomy, and de-risking should be balanced with the promotion of a frictionless trade within the EU. The goal should be addressed by the systematic enforcement of Single Market rules and the full harmonisation of the r ..read more

The new guide launched by the Association of the British Pharmaceutical Industry (ABPI) highlights the role the pharmaceutical industry plays in setting out the information aimed to provide high-quality healthcare and supporting clinicians dealing with challenging prescribing decisions. According to the guide, resources from the pharmaceutical industry available to help guide appropriate prescribing include the Summary of Product Characteristics (SmPC), medical information and pharmacovigilance expertise, and medical advisers who can provide information and data as needed, including when it ..read more