Distributors play key role in compliance

  • Posted on 21.06.2018

Distributors play key role in compliance


Lina S. AlAbbadi

Regulatory Affairs & QA Manager and the Responsible Pharmacist at Petra Drug Store


This blog is part of the GMTCC 2018 blog series. You can follow the conversation under #GMTCC and find more details and at gmtcc.com. Check out related blogs: Swifter, Higher, Stronger: Promoting MedTech Ethics on the Global StageHow to create and maintain an ethical culture, Global Responsibility, Global Ethics and Compliance, Global Principles for MedTech Innovation, Progress and new challenges after 10 years of collaboration, New industry code must safeguard independent medical education and Health data can transform our lives-but must be used wisely


In the global marketplace, multinational medtech companies must select partners carefully.

A good reputation is hard-earned but easily lost. For international medical technology companies, ethical and compliant behavior is increasingly important. Global companies in Europe and the US have signed up to robust industry-wide compliance codes, setting out how their people should behave when representing the company. With these changes, staff are expected to be well trained and compliance with the industry code is closely monitored.

However, compliance can become more challenging when operating in markets where manufacturers enter partnerships with local operators. Some regions have higher levels of perceived corruption. As the Corruption Perception Index illustrates, large swathes of the world map are considered to be risky when it comes to unethical behaviour. 

Opting out of all countries and regions where corruption levels may be high is impractical as it would close off some of the largest and fastest-growing markets in the world.

There is good reason for collaborating with reputable companies familiar with the regulatory and cultural environment. Of course, partnerships are not without risk. The manufacturer’s reputation is only as good as the conduct of their local distributor.

The key to maintaining high standards is close engagement between suppliers and distributors. Due diligence in advance of collaboration can help companies to understand whether a distributor has systems in place to ensure compliance with legal, regulatory and voluntary codes of conduct. These can take the form of questionnaires or site visits.

Reputable distributors should welcome audit and monitoring from suppliers. Indeed, it ought to be viewed as a valuable review of systems and practices – a form of free consultation that rewards excellence and highlights any shortcomings that need to be rectified. Audit can help as catalysts to take distributors to a higher level.

In my organization, we devote considerable resources to protecting our reputation and, by extension, the reputation of our suppliers. To be compliant with various industry codes and company standards, our Code of Conduct is thicker, adapted and overall more encompassing than that of our partners.

At the heart of compliance is training and reporting. We methodically train new employees – and refresh training for all staff – in ethical behaviour. This empowers them to identify and report inappropriate actions.

It is essential to have robust reporting and investigation systems in place that ensure issues are recorded and dealt with promptly and sensitively. We have an email ‘hotline’ in place allowing staff to report concerns to our Ethics Committee. This triggers a confidential investigation and provides feedback to the reporting employee.

Employees who highlight possible violations are protected from unfavourable treatment or harassment – giving them confidence that they will be supported for doing the right thing.

All of this requires ongoing commitment and resources but is always worth it. Investing in compliance is a vital ingredient to long-term sustainability of distributors, and to the capacity of suppliers to ensure compliance around the world.

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