Regulatory Focus™ > News Articles > 2020 > 2 > EU Regulatory Roundup: US Embassy Sounds Alarm About Dutch Compounding of Patented Drugs

EU Regulatory Roundup: US Embassy Sounds Alarm About Dutch Compounding of Patented Drugs

Posted 06 February 2020 | By Nick Paul Taylor 

EU Regulatory Roundup: US Embassy Sounds Alarm About Dutch Compounding of Patented Drugs

Welcome to our European Regulatory Roundup, our weekly overview of the top EU regulatory news.
US Embassy Sounds Alarm About Dutch Compounding of Patented Drugs
The US Embassy in the Netherlands has warned the Dutch government’s policies may “undermine” intellectual property rights for medicines.
Last year, the Netherlands passed legislation to permit pharmacists to prepare patented medicines despite the presence of intellectual property that otherwise grants a monopoly to one organization. Attempts to take advantage of that option have run into difficulties, with one hospital temporarily stopping making a drug amid quality concerns, but the desire to circumnavigate high prices remains.
That desire extends to the Dutch government, according to the US Embassy in the Netherlands. The US Embassy said it understands the government “plans to implement policies to expand compulsory licensing and compounding of pharmaceuticals.” Those plans have not been well received by the US Embassy.
“Such policies send a clear message to companies that IPR in the Netherlands can be undermined or circumvented for short-term financial benefits,” the embassy wrote. “Such regulatory change could allow patented medicines to simply be replaced by a cheaper, non-patented copy.”
The embassy went on to outline the potential consequences of the Netherlands diverging from global patent norms, specifically as it relates to the country’s ambition to build a life sciences hub around EMA’s new headquarters in Amsterdam. In closing, the embassy encouraged the Dutch government to “work collaboratively to address these concerns in a way that does not harm pharmaceutical IPR and the Dutch investment climate.”
Embassy Statement
Spain Creates Guide to Sharing Information About Nitrosamine Testing
The Spanish Agency of Medicines and Medical Devices (AEMPS) has created a guide for companies affected by a request to test products for nitrosamines. AEMPS’ guide walks manufacturers through the steps they need to take, starting with analyses of the risk of their products being contaminated.
Faced with evidence that a rising number of drugs are contaminated with carcinogenic nitrosamine impurities such as N-nitrosodimethylamine, the European Medicines Agency (EMA) asked companies to assess whether their products are at risk late last year. This week, AEMPS followed up on EMA’s request by setting out what companies need to do to comply with the regulatory requirement.
The first step is to analyze the risk of nitrosamine contamination in finished products. AEMPS wants manufacturers to perform those analyses and report the results as soon as possible. The deadline for sharing the results is 27 March.
EMA previously said manufacturers that discover their products are at risk of contamination must do further confirmatory testing. AEMPS lists those tests as the next step in its guide to how to respond to the contamination risk, although it will permit manufacturers to submit the results of confirmatory tests at the same time as they share the findings of their risk analyses.
AEMPS wants manufacturers to share data from confirmatory tests as soon as possible. At this stage, there is no mandatory deadline for sharing test results, but AEMPS is advising manufacturers that it is possible authorities will impose specific delivery times in the future.
The final step in AEMPS’ guide applies to manufacturers that need to take action in light of the risk of nitrosamine contamination. Manufacturers in that situation will receive additional information from authorities about how to implement the required changes to their marketing authorizations. In all cases, the manufacturers will need to implement the changes by September 2022.
AEMPS Guide (Spanish)
Belgium Posts Law on Drug Shortages Ahead of Mid-February Start Date
Belgium is set to bring new rules on drug shortages into force later this month. The law imposes new reporting requirements on organizations facing temporary supply disruptions and grants substitution powers to pharmacists.
Lawmakers in Belgium adopted the bill in December, at the back end of a year in which pharmacists across the European Union felt shortages got worse. The vote on the bill set Belgium up to gain new powers to prevent and manage shortages. Now, with the publication of the law in the Belgian Official Journal, the changes described by the text are set to come into force.
Key changes enacted by the law include the strengthening of the notification requirements covering temporary supply disruptions, according to law firm Van Bael & Bellis. That change is intended to ensure stakeholders are better informed about supply disruptions.
Other changes affect what stakeholders can do with that information. One new option available to authorities is to impose a temporary ban or restriction on the exportation of a drug that is in short supply. Another new power enables pharmacists to dispense a different product with the same active ingredient if the prescribed medication is unavailable.
The law is due to come into force on 13 February. However, royal decrees covering the details of how aspects of the law, including the export bans, will work in practice remain in development.
Belgian Journal, Van Bael Post, More
Work at Dutch MEB Disrupted Again by Technology Problems
The Dutch Medicines Evaluation Board (MEB) has suffered another technology problem that has disrupted its work. MEB’s latest problem stems from technical issues with its communications and internet provider.
Last month, MEB employees were rendered unable to work by the agency’s decision to shut down some systems in response to a cybersecurity vulnerability. Those systems later came back online, but MEB ran into new difficulties this week.
The technical issues mean MEB cannot be reached by telephone or email. The problem extends to MEB’s general telephone number. One line remains available, but MEB only wants people to call it if they have an urgent matter.
MEB Notice
MHRA Keeps Fees at Same Level for Another Year
The United Kingdom’s Medicines and Healthcare products Regulatory Agency (MHRA) has kept its fees at the same level for another year. MHRA last changed the fees it charges for regulatory services in 2016.
Since resetting its fees, MHRA has made some small additions to its list of charges. For example, the current fee schedule features a £207 ($267) charge for notifying MHRA of an amendment to a clinical trial of a Class I, IIa or IIb medical device that is neither implantable nor a long-term invasive product. MHRA also added a fee for notifications related to implantable and long-term invasive products.
However, all the fees that MHRA set in 2016 will remain at the same level in the agency’s 2020-2021 financial year. Despite keeping fees flat, MHRA has continued to turn a profit. Last year, MHRA had a surplus of £25.8 million, as compared to a surplus of £13.8 million in the year it last increased its fees.
MHRA’s financial figures last year benefited from £6 million in support payments related to Brexit. The additional support more than offset the negative effect of MHRA’s reduced role in EMA work.
MHRA Update
Other News:
EMA has raised the flags of the EU and its member states at its new headquarters in Amsterdam. The agency moved into the building at the start of 2020, having spent most of last year in temporary accommodation. However, EMA held off on raising the flags until this week, around one year after it lowered the flags at its former home in London. EMA Notice
The Finnish Medicines Agency (Fimea) has switched to electronic signatures. Fimea Notice (Finnish)


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