Dr Hans-Georg Eichler, Senior Medical Officer for the European Medicines Agency

 

 

Dr Hans-Georg Eichler is Senior Medical Officer for the EMA. In this enlightening interview, he talks to International Innovation about developments in drug regulation and what he sees as the future of pharmacovigilance

Could you explain the overall aims and objectives of the European Medicines Agency (EMA)?

 

The EMA is the European drug regulatory agency for human and veterinary medicines. Specifically, we coordinate the European regulatory network, which is dissimilar from the U.S. where you have a system that we may call a monolithic system – one FDA that is in charge of all 50 U.S. federal states. In Europe we have a different history where every Member State still has their own drug regulatory agency, but they are coordinated by ourselves.

In what way is the Agency responsible for the scientific evaluation of medicines developed by pharmaceutical companies for use in the European Union?

 

Because of the history of the European Union, there are different routes via which a drug may enter the market. In the national or decentralised routes, a company can apply for a licence in one Member State, or through a more complicated procedure of mutual recognition. The majority of innovative agents, however, come through what we now call the centralised procedure, and here EMA takes the lead – there is a single application and evaluation at the European level, which – if successful – results in a single EU licence. When a company applies for a marketing authorisation, there will be two teams from different Member States tasked to review and evaluate the entire dossier in terms of quality, safety and efficacy. These two independent reviews are then made available to the CHMP (Committee for Human Medicinal Products) for their discussion and assessment, which we see as an added quality assurance feature of our procedure.

As the approval point for all medicines for human and animal use is derived from biotechnology and other high-tech processes, you have a weighty responsibility. Does this sometimes present certain challenges?

 

I would take out the ‘sometimes’ – it always presents challenges! Drug regulation is never straightforward – all drugs have risks, even the best ones, but the key challenge for us is not just weighing the benefits against the risks, but balancing two conflicting goals: to enable early access to beneficial drugs for patients who are waiting for them, and to gain as much knowledge as possible about the drugs and their longer term benefits and risks. There are broad guidelines which are certainly useful, but in the individual case it always comes down to judgement call.

 

EMA covers both animal and human medicine in their remit; how does the process differ for approval and testing between the two?

 

For both human and veterinary medicines, the overarching principle is that the benefits of a drug should outweigh its risks. From there on, the two start to differ: there are somewhat different legislations and there are also very different market sizes – the market size for veterinary medicines is currently about 3 per cent of that for human medicines. Also, the benefit-risk assessment, which is the core task of EMA, is somewhat different: for human drugs, the benefits and risks are accrued only by the person who takes them. In veterinary medicines for food-producing animals, the risks and benefits may also extend to the consumers, and even to the environment, for example in the case of drugs for fish.

By what means do you ensure and monitor the safety of the medicines you assess after their licensing? If adverse drug reaction reports come to your attention, what measures do you take?

 

In the past, a drug would come to market, receive a licence based on clinical trials, and the only post-licensing safety monitoring was what we could call reactive pharmacovigilance or passive pharmacovigilance. We are now in a situation where companies are required to come up with what we call a Risk Management Plan. This means that at the time of licensing, the company has to agree a plan with the agency that outlines knowledge gaps, along with actions and a timetable to address them and review the results. We have moved from one-off licensing, where in the lifetime of the drug there was only one interaction between the regulator and the company, to a live license, where we go through repeat cycles of benefit risk assessment through the drug’s entire life cycle. A new challenge we now face in long-term monitoring is how to differentiate true signals from false ones. The task here is to avoid overreacting to a false signal and restrict or, in a worst case scenario, withdraw a drug.

To what extent is the Agency involved in stimulating innovation and research in the pharmaceutical sector?

 

Our basic role is to protect public health. That cuts two ways: on one hand, we should protect the public from unsafe and ineffective medicines; on the other, we should also protect patients from untreatable or untreated disease. This translates into a mandate to support the development and bringing to market of useful drugs. The attrition rate of drug research has become very high, and with it investment costs, effort and resource requirements. It’s a hugely inefficient, wasteful process, and isn’t really sustainable. Whilst some drugs fail in development simply because our understanding of pathology and biology is less than complete, others fail not because the drug itself fails, but because the company carried out the wrong studies. EMA has established a process through which we advise companies on what they have to do to demonstrate efficacy and safety, meaning not that the result will always be positive, but at least the study will be the right study. This ‘scientific advice’ is a key activity for us, and we hope that continued dialogue with the industry will help to reduce the attrition rate.

How crucial would you say collaboration is to the smooth running of EMA? Has collaboration given rise to policy change on any level?

 

We coordinate the European regulatory network, so collaboration with the Member States is the basis of our daily operations. Beyond that, we have very good collaborations with extra-EU regulatory agencies, with the FDA, Health Canada, Australia, Swiss Medic and others. This is important because drug development is globalised, and we have recognised that we need, in the interests of drug development, an almost harmonised development plan to enable companies to develop new drugs without duplication or wastage of resources. We also inform each other about our regulatory actions – when there is a safety signal in one jurisdiction we will inform the other.

What has your partnership with the World Health Organization and other regulatory authorities around the world enabled?

 

Our shared interests and collaborations with the WHO have enabled many things. One is that within European legislation there is a special article enabling us to support marketing authorisation in non-EU countries, for example in Africa and developing countries. Another is the so called list of pre-qualified medicines that WHO issues. If we authorise a drug in Europe, and WHO considers that drug to be essential for those countries, they would put that on a list of pre-qualified medicines, through which other nations could issue a facilitated licence.

What do you anticipate will be the next stage of expansion for your work, and how optimistic are you in terms of EMA’s ongoing success and growth?

 

I am optimistic about our long-term future. In spite of the current difficulties that drug development is presently experiencing, there are important basic scientific discoveries in medicine and other domains waiting to come to fruition. There will be new generations of drugs and we will have to be in a position to assess them to the best of all possible ways. For the near future, the EU has adopted new legislation coming into force mid-2012, called the European Pharmacovigilance Legislation, which addresses the post-licensing life of a drug. Through this legislation, our agency will be given even wider powers and broader responsibilities to look at how a drug performs on the market.

www.ema.europa.eu

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