This week the Center for Health Solutions is delighted to bring you a guest blog from one of our regulatory compliance specialists in health care and life sciences:
The pharmaceutical industry operates in one of the world's most regulated environments. To maintain a licence to operate, pharmaceutical companies must comply with a highly complex set of laws and regulations. Over the lifecycle of a drug, companies must adhere to both commercial compliance (such as Anti-bribery and Corruption (ABAC), off-label promotion and industry specific compliance obligations, (such as Good Clinical Practice (GCP), Good Vigilance Practices (GVP) and Good Manufacturing Practice (GMP)).
Over the past few years the pharmaceutical industry has seen a proliferation of regulatory change which they must observe to ensure ongoing compliance. Accurately interpreting the legislation and implementing any necessary changes in a co-ordinated, cost efficient and timely manner, across a number of business functions, has tested the capabilities of the industry.
Looking to the future, the regulatory landscape in pharmaceuticals is expected to be increasingly challenging and uncertain. Regulatory authorities continue to increase their compliance oversight and enforcement activities for existing laws. Simultaneously, regulators are introducing new rules and requirements which will affect materially how pharmaceutical companies do business. Through change regulators are looking to optimise existing processes and remove unnecessary duplication. In this dynamic environment pharmaceutical companies continue to invest significant time, resource and effort to achieve regulatory compliance; while, at the same time, certain parts of the regulatory environment are still unfolding.
If companies fail to comply with regulatory obligations, the repercussions can be significant. The relevant authorities can demand exhaustive remediation programmes, require extensive re-inspection and may apply substantial fines. Regulatory failures can be very damaging to the integrity and trust agendas that companies have invested so heavily in over recent years.
The regulatory operating models, employed by the pharmaceutical industry to maintain their compliance positions, have grown organically over time as regulation has evolved. Typically, compliance services are often siloed in nature, in part reflecting the business function they support. Historically, they have often lacked an overarching strategy and governance which can result in:
- potential non-compliances
- duplication of effort or redundancy of process/organisation structures
- a lack of standardisation
- a compromised ability to respond nimbly to emerging regulation or compliance issues as they occur.
In managing the complex regulatory environment, forward thinking pharmaceutical companies are looking at how best to respond to continuing regulatory change and are going well beyond the basic requirements at a function by function level. A better understanding of compliance organisation structures and the responsibilities for compliance activities, allows companies to identify opportunities to rationalise and simplify compliance operating models. Ultimately, the goal of pharmaceutical companies should be achieving more effective mitigation of the most intrinsic industry risks, such as interruption to drug supply and safety concerns.
Regulatory compliance models of the future will no longer be a back office capability, but instead, a fundamental cornerstone of future good pharmaceutical business practices. Global risk and compliance programmes are being implemented which will seek to integrate compliance processes and technologies. Organisations are being redesigned to instil a quality and compliance culture. Commitment and accountability of compliance adherence and implementation will be driven at board level, with compliance rooted deeply within company strategy and linked to individual performance metrics.
In 2012, the Good Vigilance Practices (GVP) regulations were introduced. The regulations sought to strengthen the safety monitoring of drugs, clarify roles and responsibilities, increase the use of post marking studies, improve transparency and strengthen generally the ability of regulatory authorities to further protect public health. The GVP legislation brought about a new era of cross-functional company and industry collaboration, as companies have had to respond by not only process and technology changes but re-evaluation of roles and responsibilities and organisational redesign. There has been a need for a significant investment in resource to promote compliance, which has placed a greater burden on pre-existing legal and compliance groups.
Over the past two years the specific challenges of new GVP legislation have revolved around:
- interpreting the legislation
- estimating the depth and scope of change required – this is typically underestimated
- meeting the tight timeframes to achieve compliance.
Although improved harmonisation and efficiencies will be realised longer term, there have and will be significant hurdles to overcome to implement the changes. As a result, the pharmaceutical industry has recognised the need to be more agile in adapting and preparing for future change. A number of companies are seeking to achieve this through the development of a global, integrated regulatory compliance framework.
Managing the complexities of a harmonised, increasingly complex, global regulatory landscape has become the prime concern for any pharmaceutical organisation. Indeed, those organisations who successfully implement an effective regulatory compliance framework are likely to be able to differentiate themselves from their peers, by articulating to patients the rigor invested in the development, and on-going manufacture and use of drugs, to deliver improved health and quality-of-life outcomes. This will not only help drive value but will provide an opportunity to address some of the reputational issues that are so often raised against the pharmaceutical industry.
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