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The Evolving Role of European Regulatory Agencies

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The regulatory landscape can change in a very short period of time. Matthew Walker, Senior Regulatory Affairs Executive at TRAC attended the recent joint meeting between The Organisation for Professionals in Regulatory Affairs (TOPRA) and the European Medicines Agency (EMA) where they discussed the likely future role of the Regulatory Agencies and how they will continue to work with the pharmaceutical industry and patient groups to safeguard public health.

Improving regulatory procedures for medicinal products in Europe

What we have in place in Europe already provides an excellent means for bringing products to market.  Many would consider the Centralised Procedure, which was first introduced in 1995, the ideal route for approval within Europe.  Since 2005 the Centralised Procedure, coordinated successfully by the European Medicines Agency (EMA), is now a valid route for many Consumer Health products, biosimilars and generics.  It has a number of advantages for the companies that use it, the regulators and for public health; allowing simpler and perhaps better regulation of medicines, easier and better distribution once a product has been approved for companies, as well as a better supply chain and improved pharmacovigilance .

Whilst the Centralised Procedure works very well, obtaining approval in Europe is now slower than in the US and sometimes slower than markets such as Japan.  This is due to the legislation and the requirement of the Commission’s involvement in the decision making process which results in applications taking around fifteen months to complete. It is the preferred system for many organisations but would be even more attractive if submissions could be reviewed faster.  

The EMA’s ability to approve applications is dependent upon the available capacity of the Committee for Medicinal Products for Human Use (CHMP) for reviewing submissions.  It would not be feasible for everyone to use the Centralised Procedure working to current processes.  However focusing more on complex assessments and less on straight forward applications could provide a way forward within the CHMP to address such an issue and improve efficiency.

Granting conditional approvals could also be an effective way to speed up this process whereby medicinal products are given approval  based on an initial review of positive clinical data and then given full approval once a complete review of all the data has been undertaken (studying its effectiveness following use over a period of time).  This is currently used much more effectively in the US than it is in Europe.

Finally, another innovative solution to improve the European approval process could involve creating a product monograph as a mirror for the branded medicinal product to deal with all the generic applications once its ten year period of exclusivity ends. This could be implemented via a system where the products can be placed on the market and a report is submitted every six months to say what has been marketed during that period.

However effective the Centralised Procedure is or can be, companies will always need to be able to justify the costs associated with obtaining approval in all of the EU Member

States, if they only plan to market the product in one or two states this will still not be the best option.

Improving timescales for scientific approval and market access

The issue of access to medicines is very important to patients and even more so when considering access to orphan drugs. The EMA is currently working on the idea of creating a working party that would bring together the information that is required by all Member States in post-marketing studies. The creation of this working party could help to facilitate and speed up decisions on reimbursement and pricing which would in turn facilitate the access to these medicines

To help medicines gain quicker market access the Health Technology Assessment (HTA) bodies and regulators need to try and agree on a scientific viewpoint; something which could be achieved by sharing information early on in the process and having joint scientific advice. This is not as easy as it sounds, when looking at global development, other parts of the world will have different objectives which will not only challenge how the two can cooperate together but also in terms of implementing this as part of the actual process too. However we can see the HTA bodies starting to try and address this, for example the National Institute for Health and Clinical Excellence (NICE) are moving to deliver their opinion at the time of authorisation so the scoping is starting well before dossier submission and then moving in parallel.  There are other similar schemes being implemented by some of the other HTA bodies too.

When you look at market access there are several layers within the process -reimbursement at the HTA and then pricing at the national level.  In many member states you are also working at the regional and in some cases provincial level too. In the UK alone there are four HTA bodies, addressing these layers can be very expensive and complicated for industry.

For over the counter (OTC) products it should be relatively easy to achieve market access since they don’t have to be assessed by the HTA, companies can price and place products on the market themselves. The problem relates to getting new molecules through Prescription Only Medicine (POM) to Pharmacy (P) switching. So many drug products in the UK have been switched from prescription only to pharmacy sale going on to general sale status that the pipeline is beginning to dry up.

Viagra is a recent case which was withdrawn because EU Member States could not agree on switching; this was believed to have been caused by the different views of the role of the pharmacist across Europe. Finding a way past these kinds of barriers to switching would help to address the issue of market access to medicinal products.

Increasing patient involvement in regulatory procedure and the decisions of market access

Patients are already involved in regulatory procedures at the EMA with patient representation on three of the scientific committees but in the decision of public access could patients be more involved in HTA decisions? Perhaps we have reached a point where another good step forward for better involvement would be to have representatives sitting on CHMP. As end users of the medicine, this is another effective way for patients to give their perceived view of benefit/risk of medicines in addition to the regulators or physicians.

A public survey conducted a few years ago by The Medicines and Healthcare products Regulatory Agency (MHRA) highlighted little awareness or interest of the organisation but the public felt it was important that someone was looking out for them and ensuring that medicines were safe.  There is a lot more that can be done in communicating to the general public above having patient representative groups.

In the last year the UK has taken two actions with regard to safety restrictions on medicines involving the use of cough medicines in children under 6 and reducing pack sizes for products containing codeine. Although these changes were negotiated with regulators, pharmacists have since revealed that there was an overall lack of understanding from the general public who didn’t appreciate the problem and simply felt deprived of the medicine. This further demonstrates that there is a need for the development of effective communication to the patient population away from patient organisations that could influence the risk/benefit decision both ways.

How far should transparency go in terms of the regulatory process?

Transparency within the industry is currently a hot topic but how transparent should we be of the regulatory process in an effort to build stakeholder confidence? CHMP is very open but in the past few years it’s been industry that has been excluded more and more from this process. While there are some good reasons for this, there could be more done to have greater industry representation in the discussions on committees.

One of the challenges for professionals working in the field of Regulatory Affairs is to get out there and explain to people what the regulatory process is; gaining more understanding will consequently advance transparency.

However there are times when transparency can be too effective. The testing of Patient Information Leaflets (PILs) is a good example whereby patients can often list a whole host of side effects which can create a negative effect on patient compliance and patient confidence. The key is to effectively educate medical professionals and patients whilst ensuring transparency in the regulation process.

Progressing towards mutual recognition between US FDA and EMA

In the essence of this forward thinking vision of the future could we one day see mutual recognition between FDA and EMA for New Chemical Entitys (NCEs)? This may be a radical suggestion which would create many challenges but we are already seeing signs of harmonisation between the two agencies with regard to some aspects of regulation.

In February 2010, the FDA and the EMA agreed to a single orphan drug designation annual report.  This streamlining of the process means that both agencies have agreed that a single annual report can be submitted by sponsors of orphan drug and biological products designated in both the US and the EU.

In September 2010, the EMA and FDA extended their confidentiality arrangements related to medicinal products which allows for both agencies to exchange confidential information as part of their regulatory and scientific processes. These new commitments for information exchange have been extended indefinitely and are based upon achievements of the previous arrangements between the EMA, the European Commission and the FDA.

These kinds of agreements also extend beyond those between the FDA and the EMA with agreements being set up with other agencies worldwide; The World Health Organisation (WHO) and International Committee on Harmonisation (ICH) are drawing upon common language to harmonise guidelines.   Harmonisation is good news for industry and it could mean that the days of many different interpretations of the same legislation/guidance are reducing. While we may not see mutual recognition for NCEs on both side of the Atlantic in the immediate future, these positives steps in harmonisation between the agencies could mean that global harmonisation of regulations for medicines is a realistic possibility.

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