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Posted 31 March 2022 | By Nick Paul Taylor 

Euro Roundup: MedTech Europe updates ethical code

3018 MedTech Europe has updated its Code of Ethical Business Practice considering the evolution in standards since it last revised the document in 2015. The updated text features additional information on topics including collaborative research and third-party intermediaries, plus a new annex about calculating the value of in-kind educational grants.
 
The trade group revised the Q&A associated with the 2015 code last year but otherwise left the content unchanged. Recognizing that standards and best business practices have evolved over the last couple of years, MedTech Europe has now returned to the guide and overhauled several sections.
 
“This revision, which also enhances usability and reader-friendliness, shows our industry’s continued commitment to ethics, integrity and transparency. By clarifying existing provisions, adding new sections to address additional types of [healthcare professional] interactions, and further developing the Code’s underlying values, the updates further support industry’s strong compliance principles,” MedTech Europe CEO Serge Bernasconi said.
 
A new section on collaborative research notes that medtech companies can collaborate with non-industry partners on scientific research if the work has a “legitimate purpose” and the roles and responsibilities are defined in writing. Each partner must actively contribute “significant skills, experience and/or resource complementary to the collaboration,” according to the code.
 
Two new questions in the Q&A address the differences between company-initiated research, third-party initiated research and collaborative research, and the definition of the term “legitimate purpose” in the context of collaborative research. A project “must enhance patient care or be for the benefit of patients, or alternatively benefit the [healthcare organization] and, as a minimum, maintain patient care” to qualify as legitimate.
 
The revised code also features a new chapter on third-party intermediaries. The code states that medtech companies “must be mindful of the fact that they may be liable for the activities of third-party intermediaries who interact with healthcare professionals or healthcare organizations in connection with the sale, promotion or other activity involving member companies’ products and/or services.” When local laws permit, that means contracts should impose obligations on intermediaries.
 
Companies are advised to perform risk assessments of arrangements with intermediaries, assessing the local laws, sources of information on risks associated with the intermediaries and other factors to gauge the potential for harm. The code also advises companies to establish “a risk-based pre-engagement and renewal due diligence program to identify, prevent and mitigate risks.”
 
 
The code also features a new annex on calculating the value of in-kind educational grants, which are defined as non-cash contributions to a healthcare organization to support an event or educational program. Examples of non-cash contributions include electronic equipment, meeting space, expertise and re-usable training products. The value of the contributions is based on the cost to the company, including logistics, documentation and training when possible and relevant.
 
The revisions will take effect on 1 January to “ensure ample time for implementation and transposition.”
 
2022 Code, 2015 Code, Press Release
 
EMA starts rolling review of HIPRA Human Health’s COVID vaccine booster
 
The European Medicines Agency (EMA) has begun a rolling review of HIPRA Human Health’s COVID-19 vaccine as a booster for adults who have been fully vaccinated with a different product.
 
Spain-based HIPRA moved its recombinant protein vaccine into a Phase 3 clinical trial at the start of March, putting it in a position to provide the preliminary results needed to trigger the start of a rolling review.
 
EMA started the review after seeing data from a clinical trial that compared the candidate to Comirnaty from Pfizer/BioNTech. The preliminary results persuaded EMA that “the immune response with COVID-19 Vaccine HIPRA may be effective against SARS-CoV-2, including variants of concern such as omicron.”
 
HIPRA will submit additional information to EMA as it is generated to inform the review of the vaccine. The centerpiece of the development program is a 3,000-subject Phase 3 clinical trial that recently got underway to evaluate the effect of giving the vaccine to people previously vaccinated with Comirnaty, Moderna’s Spikevax, AstraZeneca’s Vaxzevria or the Johnson & Johnson vaccine.
 
EMA Notice
 
Dutch MEB allows use of 4 pictograms on the packaging of medicines
 
The Dutch Medicines Evaluation Board (MEB) has cleared manufacturers to use four pictograms on their drug packaging to indicate warnings about the risks of the products in a visual format.
 
The pictograms depict pregnancy, breastfeeding, driving and alcohol. Each pictogram comes in two versions: a red version with a cross to indicate not to take the product in a particular circumstance, and a yellow version with an exclamation mark to advise the patient to seek advice from their doctor or pharmacist. MEB has provided a short explanatory text for each pictogram.
 
The pictogram are intended to improve the communication of key warnings about products, such as the fact they should not be used while pregnant or operating machinery. The were developed following a consultation last year.
 
MEB Notice (Dutch)
 
Pfizer pulls batch of blood pressure medicine from UK over nitrosamine risk
 
Pfizer has recalled a batch of its blood pressure drug Accuretic from the UK after finding it contained a nitrosamine at a level above the acceptable limit.
 
The recall, details of which were published by the UK Medicines and Healthcare products Regulatory Agency, covers a single batch of Accuretic that was first distributed almost two years ago. While exposure to nitrosamines above the acceptable levels for long periods of time may raise the risk of cancer, the risk of suddenly stopping treatment is greater than the threat posed by the impurity.
 
Pfizer is asking healthcare professionals to quarantine all remaining stock of the batch in question. Pfizer is yet to provide information on when Accuretic will be available again.
 
MHRA Notice, Pfizer Letter
 
Clinical trials, orphan drugs top agenda at Fimea’s patient board meeting
 
The first meeting of the Finnish Medicines Agency’s (Fimea) patient advisory board since the spring of 2020 discussed clinical trials and orphan drugs, while also approving its action plan for 2022 to 2023.
 
Fimea established the board to help incorporate the patient perspective into its activities and to create a direct line of communication with disability and patient organizations. One of the key goals of the board is to enable Fimea to communicate openly about what it does and why. The board is made up of 17 member organizations and representatives of Fimea.
 
The plan is to meet twice a year, with Fimea and the member organizations planning the themes for each event together. The latest meeting addressed topics such as where to find information on clinical trials and the reimbursement process for orphan drugs. The board is next scheduled to meet in the fall of 2022.
 
Fimea Notice (Finnish)

 

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