Article 36 for XIP newsletter from Peter Wittner, Interpharm Consultancy

Generics are illegal counterfeits

No, I don't actually think that, but there are several bodies around the world that seem to be moving towards creating that state of affairs.

And the Kenyan government has actually passed legislation that in effect states that generic versions of drugs that still have a valid patent anywhere in the world can be classified ed as counterfeits if the patent holder raises an objection. There is the possibility that other African countries might copy them.

Elsewhere, Oxfam claimed in July that an Anti-Counterfeiting Trade Agreement (ACTA) that was being drawn up could make generics makers subject to criminal prosecutions and result in seizures of their products “on orders from big drug companies”.

Intriguingly, it seemed according to some reports, that the EU and 12 other sundry countries that were meeting in Morocco were not prepared to publish the draft agreement. If true, it raises the obvious question of what they wanted to hide.

On top of that, the EU has also been busily seizing Indian generics in transit to various places such as Africa and Brazil on grounds of possible patent infringement

Add it all together and the evidence seems to be pointing towards Big Pharma working behind the scenes in a guerrilla war against the generic enemy.

Good guys (Brands)       Bad guys (Generics)

It seems as though we are going back to the good old days (bad old days?) when there was a clear distinction between the Branded good guys and the generic bad guys. At one time it looked as though they were both wearing identical grey hats with Big Pharma moving into generics and companies like Teva patenting and marketing their own NCEs. Now it looks as though Big Pharma is manoeuvring to redraw the battle lines and get both sides back in the trenches.

This strikes me as very odd; as if Big Pharma cannot make up its mind – will it or won't it join the dance? To use a crude analogy, it is as though it had entered into a consensual relationship with the generic world in a moment of madness and then suddenly, filled with regret, started to cry “rape”!

The oddness is because some of those moving towards the border and indeed crossing over it are big names indeed. For example in 2009:

• Novartis bought EBEWE to add on to Sandoz,
• GSK struck a deal with Aspen for generics for the developing world and with Dr. Reddy’s for the Middle East and Africa
• Pfizer acquired rights to a raft of products from Aurobindo and Claris
• Sanofi-Aventis carried on buying generic companies in Brazil and Mexico
• Merck has been making noises about using its biological manufacturing expertise to enter the Biosimilars world

So if there is really a Big Pharma initiative to try to outlaw generics, who is behind it? Well I will leave you to speculate – any speculation by me in print would probably result in my being sued for libel. For those who are unclear, defamation is called libel if made in a permanent form (e.g. in writing) and slander if spoken.

Could it be one of the companies that have started going into generics, but then lost its enthusiasm and changed its mind? Or could it one of the companies that has sworn never to get involved with generics at any cost and sees them as the invention of the devil?

There is a story from English history about a king called Canute who ruled about 1,000 years ago who was convinced that his powers were great enough to control the sea and stop the incoming tide. He was wrong.

Is there perhaps a Big Pharma King (or Kings) Canute who believes that it is somehow possible to hold back the flood tide of generics? If so, like their predecessor of 1,000 years ago, they will eventually find that they are wrong and that and could end up being drowned in the flood if they are not careful.

If you have any comments,

please feel free to contact me

peter@interpharm-consultancy.co.uk