Guest column : The UN High-Level Panel on #accesstomedicines is a wolf in sheep’s clothing

Dr Kristina LybeckerIn 2015, the United Nations Secretary-General Ban Ki-moon convened a High-Level Panel on Access to Medicines. Its charge was to recommend solutions to the fallaciously described “policy incoherence between the justifiable rights of inventors, international human rights law, trade rules and public health in the context of health technologies.” Unfortunately, their starting point was misguided, and – not surprisingly – the resulting report is dangerous nonsense.  Continue reading “Guest column : The UN High-Level Panel on #accesstomedicines is a wolf in sheep’s clothing”

Guest column : Are “prizes” to reward drug R&D a viable alternative to patents?

Given the intense public debate over access to and pricing of patented medicines, academics, policymakers, lawyers, and others have begun to think creatively about what it is that actually incentivises innovation and encourages drug development.

While doing so, it is important to identify the points in the R&D process where the failures occur. There are many : scientific and technical limitations; insufficient funding for research, particularly on neglected diseases; insufficient funding to take potentially promising research forward to the clinical development stage; and distribution problems that prevent existing treatments from reaching patients. Continue reading “Guest column : Are “prizes” to reward drug R&D a viable alternative to patents?”

India’s patented diabetes drugs : proof of the pudding

galvusFor a while it was beginning to look as if you couldn’t patent a drug in India without being opposed tooth and nail by local companies or non-profits (with good reason in a number of cases).  Some innovators complained of the Indian patent law being too pro-generics. Others said – and Apothecurry agrees – that parts of India’s patents law are vague and open to interpretation.

There were also fears that patented drugs would be hugely expensive and have a limited market. 

Januvia and Galvus are India’s first patented diabetes drugs. They launched in April and September last year respectively.  And they surprise on a number of counts.

One, they’ve got their patents and I don’t see anyone complaining.

Two, they are competing for volumes.  Why do I say that? First, Januvia launched at a fifth of its US price – Rs 43 a day.   Then Galvus launched even lower – Rs 38 a day. So both cost less than a dollar a day. Recall that generics companies got hosannas when they agreed to provide HIV AIDS cocktails to Africa at that price some years ago.

Why did they do that? Market dynamics. One, diabetes is a large market in India not just in current numbers but also the potential. Everyone knows about India’s dubious distinction as the diabetes capital of the world.  Two, the earlier patents law (of 1970 which got amended in 2005),  has resulted in 700 brands of diabetes medicines in the market and they all retail at far less. Three, and this is important,  Januvia and Galvus are not just competing with older drugs, but with each other. The fact is that both are from the same class of drugs – known as gliptins or DPP4 inhibitors – that have the same method of action in the body.  Based on existing scientific and clinical data, there are no substantial differences in the safety and efficacy of the two drugs.  But with more clinical experience and studies, this may change.

Doctors still think the drugs premium. But they are writing them nonetheless. Some 70,000 prescriptions were written in June alone.

This suggests several things.  One, drug patents are being granted in India without controversy when everyone including civil society sees them as being well-deserved.  When companies see the potential of volumes, they will charge a price the market can bear.  Three, India’s 1970 patents law was a truly far-sighted move as it has led to a thriving generics industry that will continue to act as a moderator of prices for a good number of years.

Of course, there will always be some drugs – like for cancer and HIV – where market economics and the presence of generics alone will not do the trick.  For these, a separate model where the government either steps in to moderate price or procure assured volumes at a negotiated price has to be put into place.  It won’t be right in such cases to look for answers in the patents law alone.