Annual lecture of the Medicines and Healthcare Products Regulatory Agency

From health care products to trust and reliance: the expanded role of regulatory authorities in an era of global health perils

Dr. Margaret Chan, Director-General of the World Health Organization

London, United Kingdom

1 March 2016

Distinguished staff at the Medicines and Healthcare Products Regulatory Agency, distinguished guests, ladies and gentlemen,

Thank you very much for the invitation. It is an honour and a pleasure to deliver the 2016 MHRA annual lecture.

The infrastructures, mechanisms, and agencies that protect public health on a daily basis often go unnoticed until something terrible goes wrong, like drinking water contaminated with lead, melamine in infant formula, counterfeit cough syrups and fever medications that kill hundreds of children, or falsified yellow fever and meningitis vaccines.

The reasons for these breakdowns are multiple: human error, a slip-up in good manufacturing practice, the greed that motivates criminal behaviour, or the sheer lack of regulatory capacity that dominates much of the developing world.

The recent catastrophe with the water supply in Flint, Michigan is a tragic reminder of what can happen when the need to cut costs takes precedence over the duty to keep the public safe. It also shows how quickly a mishap can topple politicians and health officials and destroy public confidence in government.

Work done by the UK’s Medicines and Healthcare Products Regulatory Agency, or MHRA, quietly and effectively protects public health on a daily basis. More specifically, it protects millions of people every day, in multiple ways.

Public confidence in the quality and safety of medical products translates into confidence in national health services and confidence in the government’s commitment to protect its people.

I wonder how many members of the general public know all the things you do to gather product-related intelligence and build systematic and broad-based barriers to harm.

Your drug and device alerts and your marketing authorization and licensing work are well-known components of the regulatory framework.

I am thinking of other functions that give the public such a wide and sturdy safety net, while also creating space for innovation.

I am thinking about the new toolkit for pregnant women that will make them better informed about the risk of developmental disorders and birth defects associated with certain prescription drugs. About promising innovative medicines that may be eligible, based on early clinical data, for inclusion in your scheme for early access to medicines.

About the way you keep watch over the content of websites, addressed to consumers that promote prescription-only medicines.

The support you provide to WHO and world health is immense. The reporting forms used in our 50-year-old programme for international drug monitoring are adapted versions of the UK Yellow Card Scheme.

Your labs have helped us unravel some deadly cases of contaminated medicines in several countries.

With your support, we will soon issue an international good practice for regulatory authorities and inspectors that can help reduce incidents of incomplete presentation of data by manufacturers or deliberate data falsification.

Our joint work on international nonproprietary names for pharmaceutical products benefits patients everywhere in the world.

Within the Agency, the National Institute for Biological Standards and Control, or NIBSC, is a global leader in assuring the quality of vaccines and other biological medicines, in developing standards and reference materials for worldwide use, and in carrying out applied research.

You are the leading WHO International Laboratory for Biological Standards and a designated WHO collaborating centre for polio and influenza.

For the R&D community, having biological standards is equivalent to what postal codes do to speed up the mail and how country codes standardize international telecommunications.

As another added value for world health, your work on biological standardization makes it possible for new high-quality competitor products to enter the market on an equal footing with those from established manufacturers.

Doing so has changed the market for public health vaccines, increasing predictable supplies and getting prices down.

Working with your European Union and global partners, including WHO, MHRA responds to the challenges created by an increasingly globalized world. Biological and pharmaceutical products and medical devices keep growing in number and complexity.

Supply chains are becoming ever more complex. Products are often produced by several companies. They may move through multiple countries and distributors before finally reaching the patient.

WHO welcomes the meeting you will hold in May to look at the future of biological medicines, including ways to keep the vaccine pipeline flowing.

New vaccines can be breakthroughs for global health, but they can also help address the problem of antimicrobial resistance, which is moving the world ever closer to a post-antibiotic era in which common infections will once again kill.

While all of these functions of the Agency and Institute may be out of the spotlight on a daily basis, they certainly become highly visible, and vitally important, during public health emergencies of international concern, like the recent outbreaks of Ebola and Zika virus disease.

To support the WHO response to Ebola, MHRA fast tracked the review of clinical trial applications for Ebola vaccines. NIBSC fast tracked the development and production of five reference reagents for use in the calibration of PCR tests and serological assays.

The reference reagent for serology assays helps standardize methods used to measure antibodies in epidemiological studies and in clinical trials of candidate vaccines and immune therapies.

Endorsed by WHO last year, these five reagents are the global gold standards used by anyone undertaking Ebola R&D. All of this work leaves the world better prepared for the next Ebola outbreak.

The new collaborative mechanisms that brought scientists, national health officials, pharmaceutical companies, and regulatory authorities together during the Ebola response establish pathways that can expedite product development during other health emergencies.

This is happening right now with Zika.