Regulatory Growing-Pains - Interview with Greer DealAdd bookmark
Many of the fast-developing countries face a problem as they seek to mirror regulation which is in place in the west. They do not always have the regulatory framework or infrastructure to implement western-style regulation and this can cause issues. Greer Deal, Director of Global Regulatory Services (GRS) and co-editor for the Membersnewsletter, InTouch, of The Organisation for Professionals in Regulatory Affairs (TOPRA) speaks to Pharma IQ about these issues and how governments and industry can work closer to develop regulation which works for both parties
Pharma IQ: You work in a wide variety of different countries, what countries do you see as posing the greatest regulatory issues for pharmaceutical companies and how can they overcome these challenges?
Greer Deal: Any country moving from a non or semi regulated market to a fully regulated one is going to be a challenge so, on the whole, this refers to the emerging markets. The key challenge is that in these markets the regulations are changing so rapidly that in some instances, the regulators themselves can’t keep up. For example, Turkey, being keen to become part of Europe, is adopting many EU regulations but this adoption can be so fast that regulations are being implemented before the Turkish regulators are fully up-to-speed on what’s involved. To address this, they are receiving training from EU regulatory professionals (some of whom are in our network of specialists). China is another challenging market especially for Western pharmaceutical companies. Why? Because too often pharma makes the mistake that China is one big country working towards one set of regulations. China is made up of many provinces and currently each has a slightly different regulatory system. It’s important to approach China at provincial level and do your research into which provinces are a viable market for your product.
With regulations changing so rapidly it’s impossible to keep up with it all. I always say that it isn’t necessary to know it all but it is critical that you know where, or who, to go to for information. At GRS we have done this by establishing a global network of independent professionals and specialists who have country and/or regional specific knowledge, who already have a good working relationship with their local regulatory bodies and, of course, can speak the language!
Pharma IQ: The global regulatory environment is an ever changing place, what do you feel have been the major regulatory changes in recent years and what trends are you seeing that you think will have the greatest impact on the pharmaceutical industry?
Greer Deal: In a nutshell, regulations are ever increasing and more stringent. The general trend is for more regulation but we must be careful that this doesn’t stifle creativity and innovation. The non and semi regulated markets look to the US and Europe to establish their own regulatory systems. This implies that, in time, there will be global harmonisation which will be true up to a point but the importance of cultures must not be underestimated. The use of embryonic stem cells is a good example of not only cultural differences but also religious beliefs and so it becomes a very emotive subject. The greatest trend is for personalised medicine with the realisation that we can no longer afford the ‘scatter gun’ approach of treating a proportion of the population with a drug which will work effectively only in some patients and not others. When I say ‘personalised medicine’ this includes diagnostics, devices, combination products as well as medicines. I also believe that we will reach a point where we can no longer say “a medicine is a medicine”. A “medicine” will involve the whole process from manufacturer to patient especially with the advancement of some technologies, such as stem cells, which need a temperature and climate controlled environment in transit to ensure successful therapy. This means that logistics companies will be very much part of the whole process. Collaboration is absolutely key for the long-term sustainability of the pharmaceutical industry and this will have to be at global level.
Pharma IQ: What have you seen as the major differences in how regulation affects small biotechs as opposed to big pharma?
Greer Deal: Biotech SMEs are actually at an advantage although many don’t see it that way! Very often the regulatory bodies will offer free advice or certainly at a heavily discounted rate to Biotech SMEs. It’s important that they take full advantage of this especially at an early stage in development. In addition, they can be far more flexible and adaptable to changes in regulation. What small Biotechs will say, however, is that the regulatory burden can be so great that they can’t afford the resource. In addition, small Biotechs in particular, are often working on such innovative technology that there is no obvious regulatory pathway to market. In these instances, they often fall into the ‘borderline’ category. These days small biotechs are more likely to have their exit planned after successful completion of a Phase II study with the hope that big pharma will buy them out and take the product through the expensive Phase III stage all the way to market. New technology tends to result in more stringent or even new regulation. The technology itself can be expensive but the regulatory burden can make it even more so which is why it’s rare to see large Biotech companies these days.
Pharma IQ: You operate closely in your work with a number of organisations, how can companies get the most out of collaboration and what are the barriers to doing so?
Greer Deal: Good communication is essential. It’s important to be open and honest and you must be able to trust each other. If something can’t be done, say so but always try and come up with a solution too. If you believe someone is being unethical, don’t be afraid to tell them and then walk away. Remember, it can take years to gain a good reputation but seconds for that reputation to be destroyed. When several parties are involved, it is important to nominate a single point of contact within each party who can plan and co-ordinate everyone’s activities. It’s important that everyone knows their role and who to consult at different stages of development. You also need an overall Project Leader who is responsible for ensuring objectives and deadlines are met. GRS specialists tend to be Project Leaders because they tend not to be as involved with the product and therefore, have an objective overview. In a successful collaboration you don’t have to be best buddies but you must have mutual respect for each other.
Barriers to good collaboration tend to be for reasons of confidentiality and the fear (real or otherwise) of someone stealing the IP. With regards to regulatory agencies, there is a tendency for them to be viewed with suspicion and so companies don’t engage with them until much later on and this can cause complications, in some cases very expensive complications!
Pharma IQ: You are co-editor for the Membersnewsletter, InTouch, of The Organisation for Professionals in Regulatory Affairs (TOPRA), how do you think pharma can make the biggest impact with its community through social media?
Greer Deal: TOPRA has very specific needs as a professional body in the regulatory sector and uses a wide variety of social media to keep its members informed. In my opinion, social media is a great way to educate and share knowledge in real time. Already you have the likes of GSK sharing their clinical data via their Clinical Study Register. Okay so this is a database of information so isn’t social media exactly but it is information being shared electronically. In the past, pharma used to be very secretive but they’ve now realised that they cannot work in isolation. Apart from anything, it’s way too expensive to keep repeating the same mistakes. Look at all the drugs which have been ‘terminated’ in Phase III!
Pharma IQ: What exciting initiatives does TOPRA have planned for the next 18 months?
Greer Deal: Goodness, well there’s a lot going on at TOPRA! They’ve just held their first 3 day Medical Devices Introduction course highlighting the increasing demand for Devices. Also new to their training portfolio is Health Technology Assessment (HTA) in Europe which is becoming increasingly important as Governments and Health Agencies consider benefit to risk ratios combined with costs and ethics. In October this year TOPRA is holding their popular annual symposium in Lisbon which brings together representatives from industry, regulatory agencies and the European Commission to discuss and understand today’s regulatory issues and debate future plans for regulation. At the same time they are running two parallel symposia in recognition of the specialised needs of professionals working within Veterinary Medicines and Medical Technologies. In 1989 TOPRA introduced the MSc Degree in Regulatory Affairs designed for professionals working in Regulatory Affairs who have already gained first-hand experience of handling regulatory issues. Very recently it has been confirmed that this MSc has been validated by the University of Hertfordshire providing a unique opportunity to study aspects of regulatory affairs at an advanced level. TOPRA is also looking at the development of more virtual services and want to develop their role as an independent platform for debate. Lastly, there is the TOPRA Awards Gala celebration in November to recognise the unsung heroes of the regulatory profession who have made an outstanding contribution to a product, a company or the profession as a whole.
Pharma IQ: Worldwide there has been renewed attention on reducing the harms of falsified medicines and many countries plan to introduce new legislation. What do you think effective legislation would involve?
Greer Deal: Well, we’re back to effective collaboration aren’t we? I have to confess that I’m concerned that for some countries this is a knee-jerk reaction and any global legislation will actually be fragmented. I also believe that more should be done to publicise the harms of falsified medicines so as to get the public engaged and on side with the agencies. They need to understand the implications, what is being done about it and the impact of the new legislation. To be truly effective, this is a piece of legislation which needs to be harmonised at global level.
Pharma IQ: More generally, what is involved in creating legislation that works for both governments and industry?
Greer Deal: Membership groups working effectively on behalf of industry plus good communication and an effective consultation process. Consideration of the risk:benefit ratio, the need to protect people and the environment without stifling innovation and assessing what other countries have done and learning from both the successes and failures. Very simplistic I know but you could write a book about this!