Pharmaceuticals are a highly regulated industry for good reason: the outsized impact medicines and treatments can have on the lives of patients. Regulatory scrutiny occurs across pharmaceutical operations, including sales and marketing, drug price reporting, patient privacy, clinical operations, medical device testing, and manufacturing. This makes pharma compliance one of the topmost priorities for companies. The ramifications of not complying with regulatory affairs in pharma can be serious, including significant financial judgments and even legal and criminal consequences.
Due to the risk of non-compliance and other threats to the pharmaceutical industry, drug developers should thoroughly understand what regulatory bodies govern them, be aware of new guidance and how it applies to them, and prioritize regulatory compliance at an enterprise level.
What is regulatory compliance in pharma?
Regulatory compliance means adhering to the legislation and regulations that apply to a company’s business. For a pharmaceutical manufacturer, this means complying with applicable laws enacted by a governing body and rules set forth by a regulating agency. Most countries differentiate between the two, with the difference between pharmaceutical legislation and pharmaceutical regulations described as follows:
“Legislation refers specifically to the creation of laws that are usually written in fairly general terms to meet present and possible future needs. They have language that enables the government to issue regulations based on the law. Passing new laws requires a lengthy process and involves a country’s legislative body.
Regulations are the rules established by an agency that interprets the laws to facilitate their practical implementation. They can be passed more quickly and simply than laws…Regulations have a way of expanding far beyond the size of the enabling law.”
To illustrate this example, consider the difference in the US between regulatory bodies like the FDA and laws that may change or update the way regulations are created or enforced. According to consulting firm PwC:
“In addition to the industry regulatory establishment (i.e., FDA, DHHS, EMEA, VA, and others), most major pharmaceutical and healthcare products companies are subject to the Security and Exchange Commission’s rules promulgated by the Sarbanes-Oxley (SOX) legislation. The intersection of SOX requirements and industry regulatory concerns is best understood within the context of the reporting and control mandates set forth under the SOX legislation’s Section 404. Industry-based regulatory compliance is highly relevant to the financial and operational control requirements described in Section 404 and thus creates additional impetus to align corporate compliance activities with multiple regulatory regimes.”
Why are there regulations in the pharma industry?
Government regulation of pharmaceutical companies extends the timeline for new drug development, but these measures are enacted in the interest of public health. For instance, in the United States, the Food and Drug Administration or FDA regulations include extensive testing of new drugs to ensure product quality, safety, and efficacy, with the additional goal of minimizing side effects. Nearly all governments have a regulatory agency aimed at protecting citizens from harmful drugs and ensuring product quality. Besides the US FDA, these include EMA in the European Union, TGA in Australia, MHRA in the United Kingdom, and MCC in South Africa, to name a few.
Regulatory agencies generally have two priorities: ensuring drug safety and effectiveness and facilitating access to medically useful drugs. But these goals are often at odds with one another, raising several important questions for regulators:
“The problem facing regulators is that efforts to achieve one goal may in fact reduce the chances of achieving the second goal. Stringent regulations designed to keep dangerous or ineffective drugs off the market may delay patient access to new medicines. Alternatively, efforts to improve drug access by lowering regulatory stringency and accelerating reviews could lead to the approval of some drugs that are either unsafe or ineffective.
The trade-off between safety and access is a central one in the regulation of new pharmaceuticals. The challenge for pharmaceutical regulators is balancing an interest for safety and efficacy with an interest for timely access. Finding the right balance, however, requires regulators to weigh the costs of unsafe or ineffective drugs against the costs of delay in the approval of beneficial drugs.”
What are the risks of regulatory non-compliance in pharma?
Regulatory non-compliance can have a profound negative impact on a pharma company’s finances, reputation, and customers. But the world’s leading pharmaceutical manufacturers and firms are still challenged to innovate while monitoring compliance risk mitigation and risk management. Therefore, most of the world’s leading drug manufacturers also face similar types of risks around regulatory compliance.
Rather than settling for siloed views of regulatory affairs – in which individual teams are responsible for ensuring compliance – pharmaceutical organizations should build an enterprise-level view of what’s happening with regulatory issues. Drugmakers can also adopt technological compliance solutions to improve regulatory compliance. For instance, the use of big data in the pharma industry is increasing across the organization, from research and development to marketing. Regulatory affairs should explore whether this type of disruptive innovation in pharma can maintain data integrity and decrease the risk of compliance issues.
How can insights management impact compliance in the pharma industry?
Insights management can help pharmaceutical firms and compliance committees reduce overall regulatory non-compliance concerns and ensure that good manufacturing practice is enforced. For example, engaging key experts, healthcare professionals, or patients in a virtual engagement platform environment allows medical affairs teams and the firm’s compliance teams to maintain vigilance when soliciting scientific input, dealing with sensitive personal medical information, or creating patient retention strategies in clinical trials. Commercial teams can also rely on an insights management platform to ensure they are engaging patients with the appropriate level of privacy or double-blinding discussions to eliminate the appearance of bias or influence.
Within3’s insights management solution provides drug manufacturers with a better way to achieve an enterprise-wide view of insight-gathering activity. To learn more about applying better insights management within a life science organization, download our white paper.