Life Science Compliance Update

March 01, 2017

Eleventh International Pharmaceutical and Medical Device Compliance Congress


The Eleventh International Pharmaceutical and Medical Device Compliance Congress will be held May 15 - 17, 2017 at the Lisbon Marriott Hotel in Lisbon, Portugal. Click here to download the brochure. Click here to register. The 2017 Co-Chairs and Planning Committee have designed the Congress around the themes of anti-corruption/anti-bribery compliance programs, data privacy, new marketplace, transparency, and the next generation of ethics and compliance programs. A full agenda can be found here.

The Congress this year features Keynote Plenary Session speakers from important organizations including the European Medicines Agency (EMA), the International Federation of Pharmaceutical Manufacturers and Associations (IFPMA), the International Organization for Standardization Anti-Bribery Project Committee (ISO 37001), the Organisation for Economic Co-operation and Development (OECD), Transparency International, the United States Department of Justice FCPA Unit and the United States Federal Bureau of Investigations International Corruption Squad. The Mini Summit panels include experts working within the pharmaceutical and medical device companies as well as legal counsel and consultants who will discuss the practical implementation of compliance control measures.

February 17, 2017

Anti-corruption: All roads lead to enforcement


When it comes to corruption, Life Sciences companies are a frequent target of investigation and enforcement. The French enactment of Sapin II is the latest in a long line of laws to combat corruption. This article explores Sapin II and why the authors feel that Life Sciences companies are among the best positioned to comply with Sapin II’s requirements.

Corruption occurs across all industries – from banking and finance to energy and mining – however, Life Sciences companies are frequently under the microscope due to a variety of circumstances unique to the industry. Among these circumstances are the fact that:

  1. Customers and influencers of prescription drug use are often public officials (i.e. HCPs can be government employees or work at public institutions),

  2. Company-sponsored event objectives can be unclear (i.e. whether a sponsored event or engagement is related to scientific exchange or is promotional/ commercial in nature),

  3. There is a heavy reliance on third parties and sub- contractors who are responsible for engaging with government officials and employees, and relatedly, and

  4.  Complex supply chains and distribution channels typically span all corners of the globe.

    Read the full article in the February 2017 issue of Life Science Compliance Update

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July 12, 2016

EFPIA Transparency Begins

Europe has recently pulled the trigger on their version of our Sunshine Act. While it is true that, with the exception of Denmark, France, and Portugal, the requirement to disclose does not have the force of law, information on money paid to individuals will be available for public scrutiny for the first time in Europe.

However, with the exception of those three aforementioned countries, pharmaceutical companies that are responsible for collecting the information must get consent from each individual healthcare professional or organization before they can publish it.

This move comes after a strong push by the European Federation of Pharmaceutical Industries and Associations (EFPIA). EFPIA, which has many major pharmaceutical companies among its members, has issued a minimum standard for what is required for disclosure for its members.

However, such a requirement that most countries involved require consent of professionals and organizations will likely result in differences in the level of compliance from country to country, and maybe even organization to organization. According to Andrew Powrie-Smith, responsible for implementation at EFPIA, "[t]here are differences in culture, differences in privacy law – Germany for instance has very strong laws – there are different socio-economic conditions in different countries, so inevitably there will be variation."

It isn't just the variation in the level of consent from healthcare professionals and healthcare organizations, there will also be differences in the way information is published. For example, for some countries (i.e., the Netherlands and the United Kingdom), there is a central database, whereas in other countries the data will be accessible via the websites of individual pharmaceutical companies.

How Are the Countries Coping?

In the United Kingdom, the Association of British Pharmaceutical Industry (ABPI) turned on its centralized database on July 30, 2016, disclosing aggregate spending of £340.3million ($450 million) by over one hundred companies. Most of the payments (67%) involved payments for Research & Development. The other third of payments was for a range of commercial activities, with roughly half of that third going toward a range of service and consultancy fees. Event-related payments (i.e., travel and accommodation) and donations and grants to healthcare organizations.

In the UK, however, roughly one third of physicians featured in the new, public database refuse to be named and some companies have faced difficulties in getting healthcare providers to disclose their own details, outlining some of the difficulties that are likely to continue and plague the EFPIA transparency effort.

Kyriakos Mikellis, President of the Cyprus Association of Research and Development Pharmaceutical Companies (KEFEA), notes that his aim is "to boost the legitimate relationship and cooperation between pharmaceutical companies, healthcare professionals and healthcare organizations, boosting credibility through transparency and making it more comprehensible to patients and all relevant stakeholders."

In Switzerland, the organization responsible for the implementation of the EFPIA requirements is, the Swiss business association of chemistry, pharmaceuticals and biotechnology. The association coordinated with various pharmaceutical associations and drafted the Pharma Cooperation Code (PCC). The PCC was drafted in an attempt to regulate interactions between pharmaceutical companies, doctors, pharmacists, and other stakeholders, in Switzerland.

EFPIA Intent

According to Powrie-Smith, the goal is not to shame physicians, but instead to "make sure we do whatever we can to make the relationship as transparent as possible, to get consent and get the information in the public domain in a way the public can access it." He acknowledges the importance of cooperation between industry and health care professionals, but is hoping that this transparency effort will provide an understanding of why such coordination is crucial.


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