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Regulatory News | 17 June 2016 | By Zachary Brennan
The European Commission’s Scientific Committee on Health, Environmental and Emerging Risks (SCHEER) on Friday announced that it’s seeking more information to update its scientific opinions on the need for non-human primate research, production and testing of drugs and devices, and whether to update its opinion on the safety of PIP breast implants and the possible link between breast implants and a rare cancer.
The review of using primates for biomedical research comes as the region has seen a marked decrease in the use of such animals from 2008 to 2011 (about 11 million animals were used in scientific procedures in the EU in 2011, including little more than 6,000 non-human primates, compared to almost 10,000 in 2008). The decrease followed the committee’s 2009 opinion on the use of primates, which concurred with the EC's view that there were “no scientific reasons to support a discontinuation of the use of non-human primates in basic and applied research, or in the development and testing of new drugs.”
The decrease also follows the adoption in 2010 of Directive 2010/63/EU on the protection of animals used for scientific purposes, which “restricts the purposes for which non-human primates can be used, requires scientific justification that no other species can be used and requires more stringent inspections of establishment keeping or using non-human primates.”
As part of its regular review of that revised directive, the EC is calling for an updated opinion from the one issued in 2009 on areas of research and testing where non-human primates continue to be used, possibilities to replace their use, and the potential implications for biomedical research “should the use of non-human primates be banned in the EU.”
By 3 July, all information should be submitted in electronic form to SANTE-C2-SCHEER@ec.europa.eu, specifying “Call for Information - Non-human primates testing” in the subject line of the email. All information is considered public and available to be used by the committee unless otherwise stated by the provider.
Less than three years after another EC committee cleared the now-defunct Poly Implant Prothese (PIP) breast implants from any major safety concerns (following a scandal where the French manufacturer ignited a firestorm of controversy over the safety of medical devices in general in the EU), and SCHEER is looking to update those recommendations with any new information.
“Over many years PIP manufacturer fraudulently made use of industrial silicone instead of the approved medical grade silicone in many of the breast implants produced. Investigations were triggered by an unusually high short-term breast implant rupture,” the committee says. “The product was thereafter withdrawn from the EU market…Given the importance of the matter, DG GROW is committed to monitor the publication of possible new and valid scientific information and allow for the update of the previous opinion on the PIP silicone breast implants in the light of such new scientific data.”
The committee is also seeking information on the possible association between breast implants in general and the rare cancer known as anaplastic large cell lymphoma (ALCL).
“The information to date suggests that women with breast implants may have a very low but increased risk of developing ALCL while the rarity of the disease makes it difficult to establish a definite causal relationship,” the committee says.
The deadline for submitting information is 4 September 2016, and SCHEER has a deadline of 31 January 2017 to offer its updated scientific opinion on PIP breast implants and the state of scientific knowledge regarding a possible connection between breast implants and ALCL.
Request for an update to the scientific opinion on the need for non-human primates in biomedical research, production and testing of products and devices
Call for experts
Request for a call for data and a literature review on the safety of PIP silicone breast implants and on a possible association between breast implants and anaplastic large cell lymphoma
Call for Information
Tags: EC's SCHEER, non-human primate biomedical research, PIP breast implants, breast implants and cancer