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Growing together

Regulatory affairs professionals are finding innovative ways to support drug development

A trellis shaped as 'RA' with 'Pharma' growing on itThe early years of the 1970s were a time when anything seemed possible; Concorde went supersonic, the first microprocessor was invented and regulatory affairs (RA) began to emerge as a health-related profession.

This was also the time that I started my career as an in-house lawyer for pharmaceutical company, Sterling Winthrop. Subsequently I've been witness to the sad demise of Concorde, seen an extraordinary digital revolution and watched RA become an increasingly important field. 

Although European legislation dates back to 1965, it was during the late 1970s when RA really gathered pace, when the then European Community - now the European Union (EU) - started to harmonise the regulation of healthcare products across Member States. 

While the legislation has long been extremely detailed for pharmaceutical medicines, for other medical products, such as devices, the EU developed the idea of the New Approach directive, where only broad concepts were written into the law and the bulk of the technological detail was delegated to compliance with recognised standards (which are more easily updated).

Though innovation is recognised in the pharmaceutical industry and drug development, it is not something that people associate with the RA profession. However, innovation is taking place in this area, in the form of new ideas for efficiency, new methods for productivity and new processes, all of which directly affect performance and growth. Better efficiency, productivity, quality and faster market access are all critical to a medicine's, and hence a company's, success.  

The global markets for medicines and medical devices continue to grow rapidly as a result of increasing affluence and ageing populations, with chronic diseases now the leading cause of death. The RA professional has to develop creative and clever strategies to deal with a rapidly evolving scientific environment and the legislative change it stimulates. Nowadays, the best RA professionals are confident and enquiring and use their skills to challenge the status quo and offer innovative solutions.

In my current role, advising on the regulatory and transactional needs for European life science companies, there are a number of trends in innovation of which RA professionals and marketers need to be aware, including scientific advances, risk management, collaboration, transparency and healthcare policy.

Scientific advances
The remarkable advances in genetics, including the human genome project, have opened new doors for the exploration of gene therapy. The delivery of functional copies of genes provides a potential method to correct a disease at its most basic level. Yet, so far, no human gene therapy products have received marketing authorisation.

At the end of 2008, to serve the need for getting advanced therapies to patients across Europe, the first EU legislation on gene therapy, somatic cell therapy and tissue engineering products was put in place. Then, in 2009, the European Medicines Agency (EMA) introduced a new Committee on Advanced Therapies (CAT) to discuss key areas in the certification process of emerging gene therapy, somatic cell therapy and tissue engineering products. Its remit includes consideration of innovative ways to deal with products that have already been used without evidence, regulation of long-term follow-up of efficacy and how to perform first-in-human trials. 

Products and services that leverage the science of genomics and proteomics (directly or indirectly) and capitalise on the trends towards wellness and consumerism to enable tailored approaches to prevention and care can be defined broadly as personalised medicine.  

Risk Management
Agencies have become much more cautious about approving truly innovative medicines, in the wake of problems with drugs like Vioxx. As a result, risk management plans are now firmly featured in the product life cycle, though it is important to look at exactly how risk is assessed and how it is balanced against benefit. In addition, the question of how to ensure that a balanced message is portrayed to both healthcare professionals and patients must be addressed.

At a recent The Organisation for Professionals in Regulatory Affairs (TOPRA) conference, stakeholders from leading regulators and industry professionals, including the Medicines Evaluation Board (MEB) in The Netherlands, the Danish Medicines Agency (DMA) and the Medicines and Healthcare products Regulatory Agency (MHRA) in the UK, looked at the common challenges of a risk-based approach to medicinal products and medical devices. 

At this meeting it was agreed that it is important that regulatory agencies co-ordinate and use their resources in the right way and that risk is seen as a shared responsibility between the marketing authorisation holders, manufacturers, regulatory agencies, healthcare professionals and patients.

With a main aim of the EMA being to get new products to patients as soon as possible, pharma and the national agencies are now working more collaboratively through the agencies' provision of scientific advice.

National and regional agencies have begun to share safety and efficacy data under mutual recognition agreements, which could help reduce the time and costs associated with developing new products. 

In today's competitive environment, reaching the market faster is critical and the integration of RA strategy into development and life cycle management activities is of considerable economic importance for companies.

Within pharma, the regulatory and commercial aspects are starting to intertwine. The most successful companies are those in which regulatory affairs and marketing understand each other, appreciate the purpose of the other function and work together towards the common objective of making new medicines available to patients. Those in RA recognised many years ago that firms cannot separate regulatory and commercial concerns and be successful. 

Unfortunately, the public continues to mistrust industry, regulators and policy makers, while at the same time increasingly demanding access to information. Pharma must therefore work more closely with patients and healthcare professionals; two-way communication is key. A recent TOPRA meeting discussed this in detail with stakeholders from leading regulators, industry and patient groups. Examples of poor communication were given, which resulted in sensational headlines and, in some cases, a drop in vaccinations of children and greater numbers of patients unwilling to take their medications. Communication professionals voiced how they should be involved much earlier on in the product life cycle to develop the collaborative communication needed.

One question that has arisen following publication of Ernst & Young's year-long evaluation of the EMA was how regulators can respond to requests for more participation and transparency from patients and healthcare professionals.

Build trust
We do, indeed, need improvements and greater transparency in regulatory and legislative areas. Transparency is good as a concept, but people often think the industry is withholding information, indicating a lack of trust between stakeholders. So how can it be rebuilt? Trust, transparency and honesty go hand-in-hand. People will accept it if all facts are given and you admit if there is something you don't know; the perception will be 'they have told us everything they know'. Involving communication professionals from the start can ensure the full facts are communicated to the right people at the right time.

An increasing concern is improving market access in an environment where policy makers and payers are increasingly telling doctors what they can and cannot prescribe. 

It is surprising that there is such a low level of interaction between regulators, health technology assessors and payers, all of whom should work together to demonstrate the advantageous benefit-risk profile of new healthcare products, given that availability of new and better treatment options is a societal goal.

With the EMA and the European network for Health Technology Assessment (EUnetHTA) having announced closer cooperation, and some Member States now piloting joint regulatory and HTA scientific advice, now is the time for closer interaction at a European level. 

Regulatory people need to be more involved in HTA-related requirements and how these may best be addressed in drug development to ensure patients can access new medicines within their national health care systems.

Healthcare payers in both the developed and developing worlds are also beginning to emphasise the importance of prevention.

At its core, RA facilitates the collection, analysis and communication of the risks and benefits of health products to regulatory agencies, medical care systems and the public. Operationally, RA is responsible for assuring that government obligations, market-driven demands and evolving scientific conventions are understood and addressed by the various stakeholders of the medical and health care system.

There have been formidable changes, particularly in the last few years, in the face of budget constraints, economic factors such as an ageing population and increasingly complex science and regulation. In this environment, RA professionals are finding clever solutions to deliver regulatory strategies that are interlinked with business needs and protect patients and improve lives. 

RA professionals should be more widely acknowledged for the role that they play in bringing medicines to market.

The Author
Anthony Warnock-Smith is a solicitor at Morgan Lewis and a member of the judging panel for the TOPRA 2010 Regulatory Affairs Awards

To comment on this article, email

1st October 2010


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