THE PHARMACEUTICAL VALUE CHAIN – CRAZY OR WHAT?
This is a confused spaghetti of a value chain where failure rates are appallingly high. From 250 patented compounds that enter the development pipeline, just one medicine is approved for sale, at a cost of £/$ billions, mainly made up of the cost of the failures…
NO WONDER MEDICINES ARE SO EXPENSIVE!
We believe that if we make it simpler, re-integrate many of the activities via vertical integration, bring in the right people – such as doctors and their patients. We will ask them what they need to take us back to when medicines were created because they were needed, not because company X has patented X number of molecules and needs to find a return on their investment.
Hence our hashtag – #PatientsNotPatents – look out for it on Twitter.
HOW PATENT LAW SHOULD CHANGE
If we ask for more evidence of a compound’s suitability for the rigours of commercialisation BEFORE a patent is awarded, greater collaboration would be necessary to collect that evidence
Examples of some of the questions to ask would be: “Are the compound’s characteristics compatible with manufacturing scale up?” Has maximum use of predictive technologies been applied BEFORE testing in animals and humans (ex vivo)?” “Are suppliers across the value chain fully competent to undertake the journey to regulatory approval?” There are many more that need to be asked to be sure the compound has a fighting chance of getting to patients.
Along with greater proof of potential success pre-patent award, if the industry starts to re-integrate new product development activities currently outsourced, then we could move to this much simpler, and in our opinion more beneficial, method of working (it used to be like this pre-blockbuster era):
Life could be so much simpler: