What does France’s new adverse event reporting portal mean for cosmetics companies?
The opening of France’s portal for adverse event reporting in March 2017 by the country’s Ministry of Affairs and Social Health is a milestone in the progression of life sciences ‘vigilance’.
Whether the product is a licensed drug, medical device or cosmetics/beauty care item, manufacturers have a duty of care to monitor how this is being experienced in the market, and for reacting swiftly to ill effects in the interest of consumer safety – not just because it is the law, but because it is the right thing for a responsible company to do.
For cosmetics manufacturers, which have some catching up to do with post-marketing safety monitoring, the existence of the new portal is a reminder that they themselves are under surveillance.
Any adverse event reports coming in via the central portal will be forwarded to the relevant product company by the health authority, which will be building up a picture not only of issues that are arising, but how they are dealt with.
This means that cosmetics companies need to be more proactive in their cosmetovigilance practices, ensuring that they have the right teams, systems and processes in place to respond to reported issues and, ideally, get ahead of them so that they can reduce their risk exposure over time.
The world is watching
Although the central, authority-managed portal is a French initiative, France is recognised as a leader in vigilance in Europe (it was one of the first countries to introduce a process for cosmetovigilance), and other markets will be watching closely to see how effective it is and what impact it has. There is every chance that the centralised approach to adverse event reporting will catch on, and that other countries will adopt a similar strategy.
One of the main objectives of the central portal is to make adverse event reporting much easier for the general public and for clinicians, by giving them a single, consolidated place to direct their experiences and findings.
This is likely to increase the volume of reports, by overcoming patient inertia (or the tendency for them to tell their friends and family, rather than the real influencers, about any bad reactions to products).
Whether France’s central health authority decides to introduce formal consequences for poor response times to problems logged via the portal remains to be seen, but the very fact that this official organisation will see the reports coming in will give them more visibility of how frequently issues are cropping up.
This could encourage closer inspection and proactive follow-ups, increasing the pressure on companies to have tight processes in place that bear up to scrutiny. And this applies as much to cosmetics companies as it does to their counterparts in adjacent life sciences sectors.
Given all of this, there is a surprising lack of awareness of the increased measures. Although there has been some communication about the portal since it went live a couple of months ago, consciousness remains fairly limited which could result in companies being caught on the back foot – and being made to look bad.
For cosmetics firms, which remain behind the curve compared to pharma and medical device manufacturers when it comes to post-marketing vigilance, the need to act is fairly acute. If they haven’t made much progress to date with cosmetovigilance systems and processes, now is that the time to do something about it – for instance by introducing capabilities for complaints recording, assessment and response management.
The longer term opportunity is to be more proactive still, using web and social listening tools to complement vigilance systems with proactive signal detection out in the market (across special interest groups and social networks, for example).
Artificial intelligence and machine learning technologies are significantly improving the effectiveness and efficiency of such tools - learning to recognise the sort of mentions to look for, and in what context. This offers companies a real chance to get ahead of adverse events – ultimately by designing better trials, and safer products.
Dr Caroline Cardoso is head of cosmetics at ProductLife Group