Euro Roundup: European Parliament backs temporary suspension of wastewater proposals
The European Parliament has called for the temporary suspension of plans to make drugmakers pay for wastewater treatment.
Under the Urban Wastewater Treatment Directive (UWWTD), pharmaceutical and cosmetics companies would be primarily responsible for covering the costs of removing micropollutants from water. Lawmakers targeted the industries based on evidence that they were responsible for releasing the pollutants. The proposal triggered legal challenges by the pharma industry.
Last week, the Parliament passed a resolution calling for the temporary suspension of the extended producer responsibility (EPR) provision that passes the costs of water cleaning to the two industries. The resolution asks the European Commission to pause the provision while it gathers more evidence.
The European Commission has already assessed the impact of the UWWTD. However, the cost estimates in assessments in Germany and Spain diverged from the Commission’s figures, raising doubts about the legislation's impact. Stakeholders have raised concerns about the Commission’s methodology and differences between the data it used and the evidence submitted to the European Medicines Agency.
The Commission now must produce a new impact assessment by the end of the year. The assessment should include a list of substances present in urban wastewater, verify the costs of quaternary treatment, and assign responsibility to the relevant sectors under the polluter-pays principle.
Other goals include identifying the potential impact on the availability, affordability, and accessibility of medicines, particularly generic and critical medicines and their active substances. The resolution noted that medicine shortages are already a major and growing challenge and highlighted the need to protect the EU’s manufacturing capacity, adding that generic drugs are a “particular case.”
Medicines for Europe, a trade group representing generic drugmakers, called the resolution “a significant milestone for patient access to medicines.” EFPIA, which represents branded drugmakers, welcomed the pause and the reassessment of requirements, warning that they risk “severely impacting supply chains and companies’ ability to manufacture and innovate in Europe.”
The water sector criticized the resolution. EurEau, the European water services association, said it “deeply regrets” a vote that showed a small majority of the Parliament stands “by the side of polluters,” rather than with municipalities and taxpayers. Water Europe said the resolution “sends the wrong signal at the wrong time,” adding that delaying implementation will make acting more expensive.
EDQM publishes guidelines on reporting disappearances of drugs from legal supply chains
The European Directorate for the Quality of Medicines and HealthCare (EDQM) has published guidelines to increase reporting on disappearances of medicinal products from the legal supply chain.
EU law requires most stakeholders in the legal supply chain to report suspected falsifications. Thefts are not explicitly subject to the same requirements. Stakeholders may not consider stolen, lost, or diverted drugs as falsified, leading them to conclude they are under no obligation to report them. Yet stolen drugs can be laundered using fake records to obscure their origins, rendering them falsified under EU law.
An EU committee shared recommendations on reporting disappearances in 2024. The EDQM guidelines expand on the document by explaining what each of the eight recommendations means for stakeholders in the legal supply chain.
The first recommendation is to introduce an obligation for all actors in the legal supply chain to report disappearances of medicinal products to health authorities. Any disappearance of medicines where wrongdoing is proven or suspected needs to be reported, EDQM said. Disappearances that look like isolated incidents involving opportunistic individuals should be recorded to enable trend analysis.
“During regulatory inspections, stakeholders must provide evidence that they are effectively monitoring their stock,” EDQM said. “A threshold can be established for the mandatory reporting of these losses. For example, repeated losses of small quantities of the same medicines over a period of time should trigger the same reporting response as a single loss of a large quantity of medicine.”
The second recommendation is for authorities to create or modify channels to facilitate reporting. EDQM is advising countries to establish a dedicated “pharmacrime” unit or designate a person responsible for handling pharmaceutical crimes. The individual or unit should serve as the central contact point for the reporting of disappearances.
European Commission updates GMP guidelines on taking and holding reference samples
The European Commission has updated good manufacturing practice (GMP) guidance on reference and retention samples for parallel imported products.
Annex 19 of the EU GMP guidelines covers reference and retention samples. Reference samples are batches of starting material, packaging material, or finished product stored for analysis. Retention samples are fully packaged units from a batch of finished product stored for identification purposes. The previous version of annex 19 came into operation in 2006.
The primary change to the new version of the annex, which will come into operation in three months, is a rewritten section on reference and retention samples for parallel imported products. The old annex only required companies to keep a retention sample when the secondary packaging was opened.
Under the new annex, companies should take a retention sample of the re-packaged finished product for each re-packaging operation and retain it for at least one year after the expiry date. The retention sample should represent the re-packaged finished product and include the primary and secondary package. Only the packaging material used needs to be retained if the secondary package is not opened.
Companies can retain a photographic or digital sample if the competent authority agrees that a physical sample cannot reasonably be retained. The photographic or digital sample should be a complete record, allow full visual examination, and permit investigations of the re-packaged product “equivalent to that possible with a physical retention sample.”
MDCG releases position paper on new EUDAMED responsibilities for device manufacturers
The Medical Device Coordination Group (MDCG) has published a position paper on the upcoming shift in responsibilities for adding certain information to the EUDAMED database.
Currently, notified bodies upload the summary of safety and clinical performance (SSCP) and the summary of safety and performance (SSP) while registering certificate information under the medtech regulations. However, responsibility is being transferred to manufacturers, which will need to ensure that uploaded SSCPs and SSPs match those validated by notified bodies during the certification process.
Mandatory use of the first four EUDAMED modules started last month, but manufacturers will only be able to upload the summaries starting in October. A 12-month transition period for notified bodies to upload the certificates ends on 27 May. Manufacturers should upload SSCPs and SSPs as soon as possible, and no later than 27 May, for devices placed on the market before mandatory EUDAMED use.
Other news
A European Parliament committee has proposed removing a planned extension of supplementary protection mechanisms from the Biotech Act. The proposed extension would give some products 12 months of additional patent protection. While the industry is pushing for broadening the extension, the committee ruled that the proposal “lacks a proper econometric impact assessment.” Press Release
The US Trade Representative (USTR) is investigating whether Germany’s “persistent underpayment” for innovative medicines is unreasonable or discriminatory. The investigation “follows months of meaningful discussions with our German partners in an effort to resolve this issue,” USTR said. Germany has proposed healthcare reforms that have received pushback from drugmakers. Press Release
