EU Speed to Access
Last week the EU Commission announced an initiative to require faster member state decision making on access to medicines, requiring decisions currently required within 180 days to conclude within 120 days for innovative drugs and 30 days for generics. Faster decision making is generally a good thing. Emphasis has been on faster approval of generics more than for innovative drugs, but in the context of the “headroom for innovation” philosophy i.e. using savings on generics to create budget for much needed new drugs, this is probably ok.
In the attached article, EFPIA’s Richard Bergstrom is however rightfully hinting at some critical aspects that the EU has largely been ignoring over the last 20 years under the free trade dogma. The EU is advocating free trade between member states to ensure that efficient markets are achieved for goods (any goods) within the EU. That makes perfect sense for most products. However what has been problematic in pharmaceuticals is that governments are each strictly controlling what price can be charged in each country. So the Italian and French governments are each setting a price, which is often different from each other, as well as different, say lower, than prices in for example the United Kingdom or Belgium. Subsequently, the EU free trade dogma is requiring to “punish” companies from using different prices in different countries. Does not make any sense to any normally functioning individual, but business as usual for EU burocrats.
Why is this an issue now? Parallel trade and price controls have been an issue for many years. Yes, indeed, but recent fiscal austerity related price cuts in a number of EU countries have resulted in further price cascading. In addition, exchange rates between Euro, British Pound and other EU currencies have ben swinging up and down dramatically.
In my opinion, it is time that the EU has the sense and courage to put limits on free trade dogmas and price referencing practices where prices are directly or indirectly dictated by a government. It will actually allow companies to do the sensible thing and price drugs where it makes sense in each country.