We wish all our clients, colleagues and friends a very Happy New Year. May 2016 bring you health, happiness and peace!
With developments in data privacy, new regulations for medical devices, and publication dates looming for the first EFPIA transparency disclosures, this promises to be a very interesting year for life sciences companies, whether in pharmaceuticals, medical devices, or biosimilars.
It was with great sadness and shock that we learned of the terrible events that took place in Paris on the evening of Friday 13 November 2015. There can be no justification for the taking of so many innocent lives. Our thoughts are with those who have been affected by these events, and their families and friends.
“Bon courage tout le monde!” To all our friends and colleagues in France – we feel your pain; stay safe and well.
As autumn fades towards winter, it is time to reflect on annual objectives and re-energise to ensure they will be achieved by the end of the year.
I am looking forward to presenting at the Seton Hall Law School and Sciences Po Healthcare Compliance Programme in Paris this month, and to attending the ETHICS Society General Assembly the following week.
The ETHICS General Assembly is their showcase event for members and invited guests, and is being held in Paris again this year. ETHICS is a society for ethics and compliance professionals working in the life science and healthcare industries, including industry associations. If you are not familiar with what they do, take a look at their website for more information: www.ethicspros.com.
As summer begins its slide into autumn, I like to reflect on the highlights of the season. For me, summer is a great time to catch up on all those things that are important, but not really at the top of my priority list. As most of my clients take time off in July and August, this gives me time to clean up my paper and electronic files, and to think ahead to the next year.
If you have also been thinking ahead, you might be interested in joining the ETHICS Society in advance of their Annual General Assembly in Paris on 24 November. The agenda looks really good!
The Ninth International Pharmaceutical Compliance Congress and Best Practices Forum to be held in Brussels on Monday 11 to Wednesday 13 May has a good mix of speakers from industry, industry associations, payers, law firms and consultants, and organisations such as Transparency International.
The subjects to be discussed are as varied as the speakers, and should provide attendees with a good all-round view of compliance in the pharmaceutical and medical device industries. I will be presenting a session on Basic Compliance Concepts and Skills on Tuesday 12 May.
Having been involved in all nine of these conferences, I believe that this conference offers a great opportunity to network with peers as well as gaining greater compliance insights.
For more information, see the conference website.
As we approach the deadline for pharmaceutical companies to begin capturing information regarding their “Transfers of Value” to Healthcare Professionals and Healthcare Organisations, some companies are struggling to implement consistent data capture processes across their European affiliates.
The EFPIA Disclosure Code has now been transposed into national industry body codes in most countries within EFPIA’s scope. However, a few countries have yet to fully embrace the EFPIA Disclosure Code, leaving Compliance & Ethics Officers in those countries, and their European leaders, with a difficult dilemma regarding how to comply with both the EFPIA requirements and local requirements.
Some countries (e.g. France, Portugal) already have onerous disclosure requirements that are enshrined in national laws rather than industry body codes, meaning that they apply to all companies regardless of whether or not they have joined their national industry association. Reporting is already underway in most of these countries with potential criminal sanctions for those companies that get it wrong.
In contrast, those countries that do not have national laws to comply with need to begin data collection from 1st January 2015 for reporting by end June 2016. If your company has not yet begun to put processes and tools in place to capture these “Transfers of Value”, time is running out for proactive data collection (which will be much easier than retrospective data collection). Contact us if you need help to get you started.
Happy New Year to all our readers and may you all be healthy, wealthy and wise in 2014!
Looking back on 2013 it is clear that many companies and individuals have encountered significant difficulties with their compliance programmes. Some of these difficulties have led to large fines for companies and individuals and also to imprisonment for a few executives of both large and small companies. Regulators and other authorities around the world are no longer focused just on the “big boys”; smaller companies have also felt the full force of the regulators in recent months.
In just the first two weeks of 2014, one company has entered into a deferred prosecution agreement with the US government; another has agreed to pay a fine of around $40m to settle kickback allegations; Japan has filed a criminal complaint against another pharmaceutical company; China has detained a former executive of a pharmaceutical company; and an Indian manufacturing plant has been issued with an FDA notice of potential failures of Good Manufacturing Practices. It is, therefore, our prediction that global regulators will continue to pursue companies and individuals who fail to comply, with potentially serious consequences throughout 2014.
Given this context, is your compliance programme robust enough? Are you managing your risks effectively? If you’re not sure whether or not you are doing enough of the right things, get in touch with us for practical help to get you on the right track.
The first batch of articles from S.E.A.L. Publishing are now available to download from our shop; just follow the links to find them. There are four Compliance Basics pieces, seven conference reviews, and an article on the use of social media by life science companies in this first batch. We hope you enjoy the articles and we welcome your feedback.
At a time when global enforcers are focusing their attention on both organisations and individuals, there has never been a better time to ensure that your compliance programme is as robust as possible. Here are just a few high profile examples from the news during June 2013:
What do the above cases have in common? On the face of it, not much. However, all involve individuals who have allegedly chosen to do the wrong thing while working for large, reputable organisations. Both their own individual reputations and those of the their employers can be at risk as a result of their actions. It is only by taking swift, decisive action that large organisations can protect their reputations against the actions of “rogue employees”. As we all know, prevention is much better than cure, so did these large organisations have adequate prevention and detection mechanisms in place, or did they believe that it couldn’t happen to them?
What about your organisation?
Categories: 
January 12, 2016 |
Author: Sue Egan |
