Improving Timescales for Scientific Approval and Market Access for Medicines

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Viagra is a recent case which was withdrawn because EU Member States could not agree on switching; this was believed to have been caused by the different views of the role of the pharmacist across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.

TRAC is a regulatory affairs consultancy created in 2001 by Jonathan and Sarah Trethowan. We help pharmaceutical companies meet the regulatory requirements needed to market and sell their products within Europe. For a medicine to be marketed it needs to meet certain standards of quality, safety and efficacy set by governments and authorised by national regulatory bodies. We work with companies across the pharmaceutical, biotechnology, medical device and healthcare industries. For more information about Marketing Authorisation for your products and dossier submission visit www.tracservices.co.uk.