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“Equipping people to make sense

of what they are given to believe”

Therapeutic licensing agencies the world over are becoming ever more demanding of safety and efficacy evidence prior to licensing of treatment and we would agree that this has been a very good thing for the population at large.

Standards have continued to be raised and made ever stricter in the push for quality. Unfortunately this has a negative aspect in which the timescale's and other inherent costs associated with following and enforcing these standards can very well mean that the availability of treatments are substantially delayed to the very serious detriment of some of those who could / should be benefiting.

New regulations imposed in the EU certainly raise the bar for the production of new medications but just how far should this process go?

In the case of small Pharmaceutical Companies trying to retain the ability to develop newer treatments, the burden of cost (both in terms of the requirement for clinical data and the higher costs of production) may actually mean that some treatments may never get to market at all.

Even for larger corporations these burdens will lead to delay and higher cost which ultimately will impact the end-user directly.

As a healthy individual with a healthy family, one could easily be swayed by the logic of greater protection and safeguards being given to the public at large but when viewed from the other side things start to take a very different perspective

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Those suffering from progressive and debilitating conditions often spend years under increasing stress and depression as they wait in hope for a solution of some sort.

New drugs are being developed all the time and they stand ready to help many thousands of those in dire straits - they may also turn out to be a serious risk for some! Our greatest concern in this sphere is that holding treatments back because they have not yet jumped over the highest hurdles so far devised may end up harming and even killing more those from lack of prompt care than would actually have been at risk in the first place!

Thalidomide was undoubtedly a big mistake when viewed from one simple perspective - it had no effective trialling in the area of reproductive medicine and it was also being prescribed for a comparatively minor ailment, morning sickness.

Whilst this can be extremely unpleasant, it is not by and large a life-threatening or severely debilitating complaint. Even so, Thalidomide has now come back into use - for treating leprosy - having undergone further research and testing and is now accepted as a worthwhile and valid therapy.

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Protection & Safeguards