WHY SCIENTIFIC LITERATURE AND COPYRIGHT COMPLIANCE ARE ESSENTIAL TO MEDICAL AFFAIRS SUMMARY

The role of Medical Affairs within a pharmaceutical or medical device company is largely centred around critical communications. If your organisation doesn’t yet have a literature management tool, there are many reasons why implementing one will benefit Medical Affairs. This article will examine the important features a tool needs to ease the burden placed on the functional groups by facilitating collaboration, enabling alerts to keep abreast of the latest literature, streamlining access to subscribed content, and simplifying copyright compliance.

As part of the Medical Affairs team, you lead the effort to explain to potential healthcare prescribers the real-world applications of a drug through the dissemination of unbiased clinical and scientific information. You communicate with payors, patients, physicians, regulators and government agencies. You manage relationships with key thought leaders and stakeholders, and serve as the voice of the company to the outside world. You often need to respond to unsolicited requests for information about a drug or device, and also plan publications to broadly disseminate information. You provide insight to the broader organisation based on external interactions and are a partner in shaping an organisation’s strategies. Your connections to external opinion leaders help the organisation monitor the pulse of the market. You’re able to highlight gaps in the data, weigh in on early development decisions, and evaluate opportunities for partnering.

All of these activities, and your reputation as a trusted, reliable source for both internal and external clients, require compliant access to comprehensive and up-to-date information via scientific and medical literature.

Because of this need for information within Medical Affairs, your role is evolving. You may now find yourself responsible for managing scientific literature and access to subscriptions for the broader organisation, either with a librarian/information manager role falling under this larger umbrella or as Med Affairs professionals wearing multiple hats, including information management.

Now, let’s take a deeper dive into the various aspects of Medical Affairs and what to look for in a content management solution to support you in your role and help make you a more strategic partner to the organisation:

Medical Scientific Liaison (MSL)

Whether monitoring published scientific literature for mentions of your company’s drug or device, or preparing for a meeting with a Key Opinion Leader (KOL), your ability as the Medical Scientific Liaison (MSL) to find the latest and most relevant information is critical to your credibility. As experts in communicating complex scientific and medical information to a variety of stakeholders, having easy, remote access to a cloud-based literature management tool is essential, as the most urgent need for scientific information usually occurs when out in the field.

Medical Information

Developing fair and scientifically balanced materials for patients and healthcare professionals, and responding to unsolicited enquiries with information that is pulled from scientific literature or pre-approved articles is fundamental to your role as a Medical Information professional. Using a literature management tool that clearly indicates whether or not this type of use is covered under a copyright license simplifies compliance for you and your team. A workflow with shared libraries and alerts is important for identifying, organising and tagging articles for this purpose. Alerts can also help you to stay on top of any new information that becomes available that would be useful in your role.

Publication Planning

As part of the Publication groups within these organisations, you are responsible for the timely presentation of your company’s scientific and clinical data – developing articles for publication in scientific/medical journals to support the marketing of your product. These publications often reference other articles and require a bibliography. Using a literature management tool that has built-in cite-and-write functionality can be highly beneficial. As medical writers, not only do you have all of the relevant articles that you’re referencing organised and available at your fingertips in a central location or shared library, but having the convenience of citing directly from the same tool helps improve accuracy and saves valuable time often spent manually creating bibliographies.

By providing easy remote access to content, shared folders and cite-and-write functionality, you are creating a streamlined workflow for each functional group within the larger group of Medical Affairs (not to mention, the organisation as a whole). With the added benefit of integrated rights management and copyright licensing, you can also reuse articles in a more copyright compliant manner and minimize additional risk to the organisation. All of these features are important to Medical Affairs and should be considered when transitioning to a new literature management tool.

Written by Heather Desmarais President, HJD Consulting LLC on behalf of CCC (Copyright Clearance Center)