Fast-paced organizations that rely on and invest heavily in R&D should not only regard published content as the heart of innovation, but also possess a deep appreciation of the system of copyright protecting this intellectual property. After all, many kinds of published literature, including news, blogs, books, journals, and standards — including the organizations’ own materials — are protected by copyright laws that place limits on how content can be used by others without the rightsholder’s permission.
Success is dependent on collaboration, networking, and sharing information. Unfortunately, from growing startups to established global companies, we hear all the time from organizations whose teams are not fully aware of how copyright applies to the content they rely on to accomplish their respective goals. Without knowing what permissions are needed to reuse content — and how to obtain them if needed — these teams can put their entire organization at risk of copyright infringement.
The Annual Copyright License (ACL) from CCC helps minimize an organization’s infringement risk by providing a consistent set of global reuse rights across millions of publications from thousands of rightsholders that complements existing publisher agreements, subscriptions, and other content purchases. The license also helps increase organizational efficiency by reducing time spent on verifying rights, obtaining individual permissions, and enabling the sharing of content compliantly between employees.
How Do Different Departments Use the Annual Copyright License?
Drug development is a lengthy and complex process that requires extensive collaboration among both internal and external stakeholders. Cross-functional groups within an organization — including research and development (R&D), clinical research, competitive intelligence, regulatory, marketing, and medical affairs — must work together and with external partners to advance drug compounds from discovery to approval for use in patients to physician education and promotion.
R&D
Literature review is an essential step in the research process; it provides context, informs methodology, maximizes innovation, and helps to avoid duplicative research. Researchers and investigators need to work from and share scientific literature for analysis and review as they identify new drug targets for development. This sharing of information increases efficiencies and accelerates the timeline for developing novel therapies and new indications for existing compounds.
Clinical Research
As clinical trials become more complex, contract research organizations (CROs) have become a trusted extension of the clinical research team assisting with trial design, patient recruitment, and trial management. In order for these collaborative projects to succeed, both the internal clinical research team and the CRO need to be able to share all documentation relevant to the project, including published literature.
“Certain projects require us to collaborate with project team members from different organizations, and we have to make sure to work compliantly here. It can be a very time-consuming process but with the Collaboration Amendment we can make sure that everything is legal, and collaboration can happen seamlessly.”
[Teresa Silveira, Global Scientific Information Manager at BIAL] (https://www.copyright.com/resource-library/case-studies/bial/)
Competitive Intelligence
Missed market intelligence can be extremely costly. Competitive intelligence (CI) is a key tool that can help organizations gain valuable insights into their markets, their competitors, and their customers to enable more effective decision-making and greater revenue. Valuable CI comes from collecting data from diverse sources, including competitor analysis, market research, regulatory updates, patent information, clinical trials, and published literature. With the ACL in place, these materials can be hosted on an organization’s CI site and accessed by staff to help analyze the market landscape to identify opportunities for drug development, improved product positioning, and enhanced customer satisfaction.
Legal/Regulatory Affairs
Meeting regulatory requirements for clinical trials and new drug submissions is an essential part of conducting clinical research. Medical literature is a key source of safety information about these products, as new types of adverse reactions may first come to light as published individual case reports or as part of published clinical studies. Regulatory Affairs groups need to work closely with other departments to centralize and organize the published literature that will be submitted to support a regulatory filing for a new drug or new indication. It is important that this team not only has the ability to share these documents internally but also permission to share them with appropriate government agencies as a required part of the regulatory submission package.
Marketing
To make physicians aware of new products, promotional literature is prepared for publication in journals and for use by sales representatives. Claims made in these materials must be supported by the outcomes of published clinical research and full-text copies of these supporting materials must be stored and available for reference.
Medical Affairs
One important role of the Medical Affairs team is to explain to potential healthcare prescribers the real-world applications of a drug through the dissemination of unbiased clinical and scientific information. They are responsible for communication with payors, patients, physicians, regulators, and government agencies, and frequently need to respond to unsolicited requests for information about a drug or device.
Drive Business Forward with the Annual Copyright License
A copyright compliance strategy that informs and meets the needs of employees across the enterprise sets up an organization for higher efficiency, improved collaboration, and a minimized risk of copyright infringement, ultimately helping to fuel innovation and new discoveries.
Interested in seeing real examples of how R&D teams use the Annual Copyright License and our other solutions? Check out our case studies featuring customers in life sciences, biotech, chemical, consumer goods, and more. Click here to contact us about content management and licensing solutions for your organization.