Insights from PCC Canada and a Look at Innovative Medicines Canada’s Voluntary Reporting Framework
“If you think compliance is expensive, think about non-compliance.” That was the provocative but true opening statement by conference chairperson, Chrisoula Nikidis, to the Pharmaceutical Compliance Conference (PCC) held in Toronto, Canada earlier this summer. In an industry that is prone to constantly evolving regulatory changes, this commentary clearly articulates the real value of a current and approachable compliance program. The conference focused on the key components of a compliance program, including training, monitoring and transparency reporting.
Compliance, as the conference chair noted, is everyone’s job. Accordingly, companies must be proactive in developing a robust compliance program that is tailored to the company’s unique risks. A good compliance program is also flexible so it can evolve as the company matures. For example, a company’s risk profile before approval will change after approval, and again when their drug is approaching patent expiration. Thus, the training program must evolve as well. Additionally, live compliance training is essential, as several PCC Canada panelists discussed. Live compliance training that is hands-on and involves case studies or role playing provides a more realistic and relatable experience. Furthermore, it will give employees the opportunity to apply their understanding of the company’s values and policies in a tactical way, making what they learn resonate.
The conference also focused on the important role monitoring plays in building an effective compliance program. Companies need to ensure that employees do not perceive monitoring as punitive, but rather as an opportunity to improve the business. The conference held a breakout session that focused solely on monitoring and how to implement effective monitoring practices. The presenter provided three best practices during this session. The first and fundamental step is to identify the risks prior to developing a monitoring plan (usually through a risk assessment), so that the monitoring plan’s key risk indicators are accurate and timely. Second, companies must ensure the sample size is representative across activity areas to obtain optimal results. For example, when monitoring transfers of value to HCPs, companies should not just focus on cash payments, but should also look at travel reimbursements. Similarly, when companies are monitoring standard fee-for-service arrangements, such as speaker programs or advisory boards, they should also consider contracts with HCPs they’ve engaged to write articles for publication. Lastly, companies should dive into the results and data outputs from the monitoring exercise to help identify, manage and reduce compliance risks that are key to the business. Identifying these risks can help detect areas for greater efficiencies and business improvements that will be helpful for the company.
Focus arrangements and preliminary due diligence on these arrangements was another key conference topic. Focus arrangements refer to transactions and arrangements involving individuals or entities that may purchase or make referrals for company products. Polaris Partner Darren Jones and Stephan Ekmekjian from Johnson & Johnson presented on the topic and highlighted the need for heightened due diligence prior to entering into a focus arrangement with government-affiliated individuals and hospital systems, such as Health Canada, as these are relationships are often targeted more than traditional focus arrangements. Presenters shared a series of considerations to help preemptively mitigate anti-bribery and anti-corruption (ABAC) risks when entering into focus arrangements, including: (1) establishing a centralized tracking system for all focus arrangements, (2) keeping service and activity logs, (3) establishing and implementing a written review and approval process for all focus arrangements, and (4) implementing an effective response system when suspected violations are discovered. Robust focus arrangements due diligence and monitoring, in combination with hands-on training, are essential tools for an effective compliance program and to mitigate risk and bolster efficiencies.
Transparency reporting was the focus of a few sessions, covering topics from global transparency requirements to updates on Canadian transparency reporting. Presenter, Darren Jones from Polaris, opened the discussion by highlighting four global trends that are changing the expectations of compliance programs:
- Rising cost of healthcare
- Rapidly evolving market and patient access strategies
- Government and board demands for management accountability
- Perceived conflicts to physician independence
Together these trends are altering the role of the compliance office and bringing concerns related to how industry engages with HCPs into sharp-focus. This focus is becoming engrained in how manufacturers operate as the demands increase from governments and our industry trade associations.
For that reason, presenter, Paul Lirette, President, Canada Pharmaceuticals for GSK discussed the need for Canadian pharmaceutical companies to follow in the footsteps of the many countries who have implemented transparency reporting within their regulations. As both presenters illustrated, approximately 40 countries (including the U.S. and many European countries) have transparency laws that require companies to publicly disclose payments to HCPs/Os, with at least 13 of those countries having pre-notification requirements as well. The conversations spurred lively discussions regarding the future of transparency reporting in Canada. Will Canada follow the U.S. and European path of mandatory transparency reporting? Will this surge in worldwide regulatory activity be a sign of things to come in Canadian Transparency? And if so, how quickly would Canadian requirements change?
Many of these questions were addressed by Innovative Medicines Canada’s (IMC) updated disclosure policy for Canadian pharmaceutical companies. Although Canada does not currently have any federal transparency regulation, the IMC released a voluntary framework on the disclosure of payments to HCP/Os in October 2015. In June of this year, ten of the largest global pharmaceutical companies, including Abbvie, Gilead, Merck and Novartis, announced their intent to comply with this framework by voluntarily disclosing (1) payments to HCPs for services such as speaking and/or consulting, (2) funding to HCOs that support charitable, educational and/or scientific activities, and (3) funds provided to HCPs to support their travel to attend international congresses and/or global meetings.
While the group of current participants is a small fraction of the IMC’s membership, former president of the IMC, Russell Williams, indicated that this voluntary framework is just the beginning. He notes, “Society is moving towards this movement of disclosure. We think this is a helpful offering to help show the value of these relationships between our industry and health care professionals.” Despite the IMC’s efforts, many individuals within the healthcare community feel more needs to be done. The president of GSK Canada, Paul Lirette, states “In my view, [the disclosure] is not good enough, but it’s a good first step.” The IMC is urging pharmaceutical companies in Canada to join this voluntary program, and in fact, the Ontario Health Minister, Eric Hoskins, has expressed interest in joining this movement by considering mandatory disclosure for pharmaceutical companies in the future. He made the announcement in mid-June and noted that “our government is committed to strengthening transparency across the health care sector.” The IMC hopes that trends like this continue and companies continue making disclosures in 2018.
In conclusion, the PCC Canada conference highlighted some best practices to achieve a better compliance program, including training, monitoring and transparency reporting. It also brought light to the common misconception that the role of compliance sits solely with the compliance function. Rather, as the conference helped to illustrate, compliance truly is everyone’s job. All employees are accountable when it comes to the process of complying, adhering and conforming to laws, rules and regulatory standards – from the sales representative who manages the sign-in sheet at a speaker program to the employee who is responsible for reviewing an HCP’s CV prior to contracting.
The PCC Canada and the recent update in the voluntary disclosure framework by the IMC illustrate that everyone in the business has a part to play in ensuring compliance. As compliance continues to become a focus area for much of the Canadian pharmaceutical industry, it will be invaluable for compliance professionals to remind themselves and their peers that everyone must be accountable.
Polaris, a QuintilesIMS company, offers global end-to-end solutions for Life Sciences companies that address the ever-changing compliance and transparency landscape. Click here to learn about Polaris’ consulting and technology solutions, or contact us.