Compliance officers in the pharmaceutical industry have many things to keep in mind when doing their jobs; consumer privacy, anti-corruption, quality control, and billing fraud just to name a few. Their compliance program needs to be robust and versatile at the same time, allowing them to implement policies and procedures, as well as quickly respond to the ever-changing risk landscape.
To explore the specific hurdles compliance teams in pharma face we published our latest ebook Compliance in the Pharmaceutical Industry: Challenges and Opportunities. Download the full eBook for an in-depth analysis of these overarching issues. Keep reading for an overview of the top five things pharma compliance teams should have top of mind:
1. Payment Transparency
The pharmaceutical industry is one of the most regulated industries, requiring compliance officers to keep track of various details. The expanded Physician Payments Sunshine Act, coming into force in 2022, also requires recording any monetary payment or other transfer of value. This means compliance professionals will need to revisit their policies and procedures for newly covered personnel. Additionally, the compliance function needs to cooperate closely with the accounting and sales department to ensure accurate tracking.
Many pharma companies widen their portfolio or strengthen their market position via acquisition of other companies in the industry. Thanks to this trend, compliance officers need to deal with increased due diligence on acquisition targets. Additionally, once the merger is completed, an equally big part of work is awaiting: compliance programs need to be adapted, blended, and harmonized.
Cybersecurity is of increased importance for pharmaceutical companies due to the large amounts of sensitive data they are dealing with. Patient data needs to be as protected as possible, and the company’s own confidential information needs to be stored securely. Moreover, compliance professionals also have to take into account legislation such as the General Data Protection Regulation (GDPR), which causes many policy and procedure questions.
4. Patient Assistance Programs
Patient assistance programs (PAPs), which aim at helping uninsured consumers to afford prescription medication, pose additional risk in data processing which needs to be monitored and evaluated closely by the compliance function to avoid excessive liability. A crucial task of compliance officers is to consequently make sure policies, procedures, and training stay current with these business needs.
5. The FCPA
The risk under the Foreign Corrupt Practices Act (FCPA) is high for pharmaceutical companies, as many overseas sales prospects meet the definition of a ‘foreign official’. Although FCPA enforcement has always been a point of attention, there are two important aspects of the pharma industry. First, compliance professionals can make sure to mitigate the Department of Justice’s (DOJ’s) monetary FCPA consequences by disclosing their misconduct themselves, cooperating during an investigation, or remediating any compliance program weaknesses. Besides, the DOJ’s Health Care Fraud Unit announced that they would start to apply the FCPA Corporate Enforcement Policy, which is why pharma compliance specialists should become acquainted with the new policy. Secondly, the Securities and Exchange Commission (SEC) still enforces the civil side of the FCPA with monetary penalties. Compliance professionals thus need to be on guard with internal controls, as well as collaborate closely with a CFO or controller to assess policies and revisit documentation.
Successfully managing these industry-focused challenges depends on the elevation and prominence of the compliance program. Compliance professionals need to make sure business is conducted in a risk-aware and compliant manner. Although this might sound as a constraint, the compliance function should treat the future as an opportunity, in which empowering and embedding the compliance program is made a priority. To get more details about the industry-specific challenges pharma compliance teams are facing, download the full eBook.