Data Exclusivity Patent

Prices of cancer drugs to rise?


krista cox tweetAccording to various tweets (sources mentioned at the bottom) coming in from Salt Lake City, where the current, and possibly last round of the TPP negotiations are happening, MSF’s prediction may be coming true – that the TPP may become the most harmful trade pact ever for access to medicines for developing countries. The USTR is going all out to get their way in the IP and Medicines round. [For our readers who want some background on the TPP, see my previous post here]. Read on for more details:

While most countries have come in with 1-3 IP negotiators, US has apparently come in with about 15-20 negotiators / IP lawyers. Assistant US Trade Representative Stan McCoy is chairing the round and has been pushing for much longer negotiations than originally scheduled. (This doesn’t seem to be the first time he’s pushed for this tactic of exhausting the opposition – see ACTA negotiations) The negotiations schedule has now been modified and is set to go on all night as well as beyond the period of stay of some of the developing country negotiators. Just to clarify – that means that certain developing countries may have only 1-2 representative in this round negotiating with/against 15-20 US representatives with the knowledge that the ‘negotiations’ will continue even after s/he leaves.

Aside from their extreme bullying though – the provisions they are pushing their weight behind is what worries me. Apparently their top priority is to get 12 years of data protection on biological products, and to allow exclusivity over minor modifications of formulations. The stress on biologics seems to indicate that they are trying to protect, if not allow a rise in the price of the cancer drugs. Biologics are generally much more complex than standard small molecule drugs and tend to be more expensive and much harder to successfully reverse-engineer. In fact, generics cannot make exact copies, as they can with small molecule drugs. Rather, as the name suggests, they can only make ‘bio-similars’ – similar drugs which are bioequivalent. This makes the process of quality and safety checks harder to determine – an aspect that is not lost on Big Pharma. For instance, the lack of biosimilars on the horizon is probably one of the main reasons Roche recently dropped their pursuance of patents on Herceptin in India . It’s also important to note that biological drugs with about $60 billion in annual sales are set to go off patent in 2015. Test data is therefore important to allowing generics to come up with biosimilars.

While biologics are expensive even by developed country standards, they are simply beyond the reach of most of the developing world. For instance, the above mentioned Herceptin which treats a type of breast cancer: For several years, it cost Rs 110,700 a vial. Recently the price has been dropped to Rs 75,000. Treatments require between 12-18 vials. And India’s per capita income is about Rs 6000 / month. These are prices that are not viable for developing countries. As Prashant pointed out in this post, there are several other factors also involved in dealing with the cost of cancer – and till we get those factors sorted out, high(er) prices are something we just cannot deal with. Especially not high prices which are ‘justified’ by claims but not proof of costs. Simply put: If more exclusion rights are claimed to be required – solid proof needs to be submitted as to why they are required. There are too many people dying for “just trust us” claims to work.

judit tweetAmongst those that have recommended against data-exclusivity for developing countries are UNDP, WHO and UNAIDS. In fact, a 12 year data exclusion period goes against what the Obama administration has said as well. Obama’s 2014 budget specifically reduced the period of exclusivity for biologics from 12 years to 7 years. In a clear sign of who is pulling the strings though, PhRMA (the consortium for Big Pharma companies) recently issued a letter saying that they require a 12 year exclusion period for biologics. No coincidence then that Japan is the only country in the negotiations that supports some of USTR’s harsh provisions on medicines and Tokyo is also the only non-US city that PhRMA has an office in.

[Earlier mentioned tweeters include Public Citizen’s Burcu Kilic, MSF’s Judit Rius Sanjuan, & KEI’s Krista Cox & Jamie Love]

Swaraj Paul Barooah

Swaraj Paul Barooah

Follow @swarajpb Swaraj has a deep interest in IP, Innovation and Information policy, especially when they involve issues relating to Access to Knowledge, Innovation incentive mechanisms, Digital Freedoms, Open Access, Education, Health and Development. After his BA, LLB (hons) from Nalsar Univ of Law, Hyderabad, he went on to do his LLM from UC Berkeley in 2010. He is now pursuing his J.S.D. degree from UC Berkeley where he is focusing on Drug Innovation Policy and Access to Medicines. Aside from SpicyIP, he is also engaged as a consultant on various IP matters, and is a visiting faculty member at Nalsar Univ of Law. He is also in the process of starting up a New Delhi based "IP, Innovation & Information Policy" focused think-tank.

Leave a Reply

Your email address will not be published.