Balancing the benefits and resulting regulatory complexities in the wake of increasingly global medicines and medical devices supply chains

Posted by: in Corporate and Strategy, Global Healthcare, Healthcare Insights, Insights, Medical Communications, Medical Devices on March 18, 2014

Insights from the UK’s Medicines and Healthcare Products Regulatory Agency (MHRA) Annual Lecture 2014

We live in an increasingly interconnected world and as we have seen with many other industries, the footprint (from raw materials to production to storage and distribution) of medicines and medical devices has become progressively more global. For example, approximately 40 percent of medicines and 50 percent of medical devices available in the US are produced outside the country.

While there are many advantages of globalization of healthcare product supply chains, such as boosting economic growth in developing countries where manufacturing is increasingly being moved, and lower costs leading to improved access; the inevitable flip side is the complexities of ensuring the quality of products is not compromised.

The Medicines and Healthcare Products Regulatory Agency (MHRA) in the UK recently invited Dr Margaret Hamburg, Commissioner of the US Food and Drug Administration (FDA) to share her perspectives on the challenges presented by globalization at the Agency’s annual lecture. Titled “New Realities of Globalization – Implications for Health, Medicine and the Role of the Regulator”, she spoke on the potential issues she anticipates over the next 10 to 15 years and the collaborative efforts of regulators internationally.

During the lecture and the following panel Q&A, there was a clear consensus that regulators around the world need to find new ways to fulfil their missions of ensuring safety and quality of products used in their local markets, while at the same time continuing to promote the advancement of product development to meet growing global health issues. Collaboration across national borders is essential, particularly as resources available to regulatory bodies continue to be stretched.

Key points include:

  • Regulators need to stay ahead of the curve to improve patient safety and national economic growth and security
  • National regulation bodies need to recognize that they cannot effectively do their domestic job without engaging with other agencies, and that they should identify shared problems and design solutions together, moving from a reactive to proactive approach
  • There is need for a global mechanism making critical decisions for global governance to assure commitment across national boundaries
  • Pharmaceutical companies must be engaged on their global corporate responsibility to deliver on quality and safety, and by holding them more accountable for their supply chain, influence them to be more rigorous
  • The industry needs to continue to raise the profile of issues such as medicine contamination and product counterfeiting into the wider public consciousness to not only put pressure on governments to do more but also drive grassroots action such as encouraging patients to report adverse events

As an industry, we must never lose sight of the patient and the important role we play in public health, and continue to be guided by a strong ethical code. By doing so, we will play our part in ensuring that the economics of globalization are all positive.

To view the lecture and panel Q&A on the MHRA’s video channel, click HERE. A transcript of Dr Hamburg’s lecture can also be found on the FDA’s website.

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