….drug company pressure on developing country officials and governments. Grrrr.

Just came across this story (on SecondView) via Jamie Love on the Huffington Post: Big Pharma company Pfizer (and there aren’t many bigger) are suing a Philippine government-owned company (PITC, Philippine International Trading Corporation), the Philippines equivalent of the TGA (BFAD, Bureau of Food and Drugs) and two Philippine government regulators personally (the BFAD director and one other staff person). What Pfizer object to is the importation, from India of samples of a drug that Pfizer sells in both the Philippines and India, and for submitting the samples to the government drug regulatory agency. It’s a fine example of inappropriate pressure being applied to government (particularly through the personal law suits), which indicates two things:

  1. Developing countries should be supported, and encouraged to use the flexibility available in international treaties – the Phillippines needs springboarding provisions and may need support to enact them; and
  2. Drug companies can be utterly unscrupulous in their use of the law. Not sure what we can do about that, but examples like this should be highlighted and publicised.

More detail over the fold.

The drug is Norvasc (generic name: amlodipine besylate). It is used to treat hypertension, angina and myocardial ischemia. The drug is under patent in the Phillippines until June 2007. Pfizer sells the drug in the Phillippines at a price out of reach of something like 95% of the population.

According to Jamie Love and Judit Ruis, the Phillippines government want – after the patent expires in June 2007 – to import versions of the drug from other countries, like Thailand, Indonesia, and other countries, where Pfizer sells the drug for much lower prices. In preparation for this, they want to import some samples for submission to the Phillippines TGA-equivalent, to get approval so that importation and sale for lower prices can commence as soon as the patent expires.

Part of the problem for the Phillippines is that their law does not include what we call in Australia ‘springboarding’ provisions – what they call in the US ‘Bolar’ provisions (for the history of the Bolar provisions, see Judit Ruis’ blogpost).

To introduce a generic (or even an imported version of a drug) to the market, regulatory approval must be obtained from the TGA (our equivalent of the US FDA). That means demonstrating ‘bioequivalence’ – to prove the drug is the same as the approved version sold by an innovator company. This takes time – according to a recent government explanatory memorandum:

‘The lead time for R&D and regulatory approval to bring a generic medicine to market is between two and six years, and sometimes longer. This means that if the patents surrounding a drug are not eligible for springboarding in Australia it can take two to six years after patent expiry for a generic company to bring the product to market if the development work is done in Australia. To ensure timely entry onto the market after patent expiry, generics companies seek to do the development they need to, and obtain regulatory approval, before patent expiry.’

Australia already has springboarding provisions that that allows activity by generics manufacturers during the patent period to enable them to collect the information required to obtain regulatory approval. As a recent EM puts it:

The springboarding provision was intended to allow earlier regulatory approval for generic pharmaceuticals, faster market entry upon patent expiry and prevent originator companies from receiving further de facto extension of patent term.

But at the moment, this can only happen during a pharmaceutical patent owner’s term extension (the extra 5 years they get on top of the ordinary 20 year monopoly, to ‘compensate’ for the fact that regulatory approval takes a while). A current bill before the Parliament, the Intellectual Property Laws Amendment Bill, proposes to allow ‘springboarding’ activity throughout the patent term (on the bill generally, see Rothnie here, IP Australia here and Freehills here).

Springboarding laws are found in the US, Canada, the European Union, Israel and Argentina. The proposed Australian changes will bring us more in line with the US and Europe.

Worth noting though that most of the countries with these laws are richer countries. Ironic, yes? This indicates to me that poorer countries need to be supported to ensure they can use this kind of flexibility themselves.

I just can’t believe that Pfizer would have the nerve to sue for this kind of activity, perfectly legal in most places around the world. The patent will be respected, they get the patent term. Actually, that’s not hard to believe – that is use of existing law. The Phillippines should be supported to amend its law to allow springboarding. I find it harder to believe Pfizer would sue government officials in their personal capacity – that is just unconscionable additional pressure to add to the equation, and just plain inappropriate.