Big news of the week of course is the publishing of the Delegated Regulation that supplements the Falsified Medicines Directive and enables the industry to take the next steps in protecting the public against the menace of falsified medicines. There will be much comment, no doubt, over the coming weeks, months and years until full implementation. What I am about to write will probably be seen as negative, but believe me I am convinced that this regulation will be a major step forward in Europe and will make a real difference. However what we must be absolutely certain about is that the bad guys will have already started seeking ways to carry on, they are not going to simply give up.
Will they find ways to continue to introduce significant amounts of product into the EU, we don’t know. My concern is that they will exploit the less well controlled markets around the globe, not good for patients but also not good for our industry. The European and US pharmaceutical manufacturers have not always behaved as we would hope in the Rest of the World markets but they produce safe, innovative and effective products, and these markets present a massive opportunity for sales in the future.
We must all work together to make a success of the changes in the next few years but we must continue to be vigilant and need to re-double our efforts to provide safe and locally affordable products to all global markets.
