PharmExec Blog

Eight Lessons for Enhancing Compliance Effectiveness in Europe

Andy Bender and Geert van Gansewinkel outline eight lessons for executing a soft change program for enhancing compliance effectiveness within European life sciences organizations.

The European compliance and transparency landscape has changed rapidly over the last couple of years. Over and above the challenging compliance landscape, there is additional complexity impacting transparency relating to the way companies are organized internally in Europe. Unlike in the U.S., where there is usually a central organization making enterprise-wide decisions, life sciences companies in Europe typically have a combination of a regional center with local country organizations.

Given these internal organizational realities, the key to success in implementing any compliance program and reporting system in Europe will be the extent to which the compliance business owner can get the buy-in of management and staff throughout the company.

In our experience, European life sciences companies that have been successful with developing a sustainable transparency and compliance program have focused on the soft side of change, viewing compliance not as a technology project to be implemented, but emphasizing change in individual behaviors.

Eight lessons learned for executing a soft change program for enhancing compliance effectiveness within European life sciences organizations include:

1. Start with an assessment of current compliance practices, systems and processes, followed by the development of an implementation roadmap. A comprehensive understanding of the types of processes and systems being utilized and what marketing, sales and medical activities take place in each of the different countries should be assessed.

2. Ensure senior management support from the beginning. Implementing a change program can take anywhere from 6–18 months, requiring many different countries and departments to work together. Senior management involvement is needed to provide and approve all necessary resources, to enable decisions to be made on a timely basis and to keep the project team on time, on budget, and on scope.

3. Establish a Steering committee.? The steering committee should be established early on. It should serve as a strong governance and core team representing different sides of the business and include central management in the area, as well as local management, who can become the champions after a successful program pilot is executed.

4. Institute a pilot program before pan European implementation. There are numerous reasons for going the pilot route, but a principal one is that it is easier to manage resources to make the implementation successful, given the scope of the project. Also, when first piloted to individual countries, these countries can be used as champions after a successful implementation, convincing the remaining countries to adopt the program.

5. Assign the program to a business owner, not the IT organization. Selling management on the added value of collecting spend and use the information for strategic decision making purposes. The spend capture, collection and reporting process can actually provide new insights into the business and help adjust and guide business strategy and direction.

6. Appoint a central Project Management Office and Change Management Office to drive execution. A specific compliance programs PMO needs to be created for taking charge of this responsibility along with the creation of a Change Management Office or function (if not already in existence) for partnering with the PMO in carrying through the needed organizational changes to ensure compliance program robustness, effectiveness and success.

7. Organize the project in distinct workstreams, making sure relevant work packages are addressed. It has been our experience that most companies overly focus on the technical aspects of implementing a transparency reporting solution or a compliance program, while forgetting that there are many related processes that need to be changed in each of the participating countries.

8. Establish a clear set of principles that will guide implementation. Companies should establish a defined set of guiding principles for how the compliance program is implemented and stick to them to ensure non-interruption, with the only exceptions being for legal or regulatory developments that emerge. Setting these principles allow for interpretation of the implementation guidelines and decentralized decision making during the execution of the program in the local countries.

Andy Bender is the President and Founder of Polaris. Geert van Gansewinkel is Polaris’ European Managing Director.

For the full version of this article, see the June issue of Pharmaceutical Executive Global Digest.

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