Campaign for Fighting Diseases Blog

How not to tackle drug registration bottlenecks

We've written before on how local drug approval agencies can be a bottleneck, delaying the registration of new, lifesaving drugs into markets - either because of inefficiency, corruption or both.

Now South Africa's drug approval body - the Medicines Control Council - has issued a mea culpa, telling the South African parliament that the agency's antiquated working practices have resulted in a massive backlog of drugs awaiting the official rubber stamp.

According to the agency's head, Mandisa Hela, it takes two to three years to register new clinical entities, 18-24 months to register generic medicines, 12-16 weeks to approve clinical trials and up to 15 months to approve fast-track applications. 

In 2003, about 28% of applications were not dealt with, and by last year the figure had risen to 98%.

And these are for drugs that have already been approved by, for example, the US FDA.

Ms Hela should have told the parliament is that their own bizarre legislation is compounding the problem.  According to Eustace Davie of the Free Market Foundation, new government rules envisage extending the work of the authority to cover all "products" that make "health-related' claims (bringing "sports" drinks and such items under its scrutiny), which will increase the number of applications at least tenfold if not a hundred-fold.

This piece of legislation will do little more than deny South Africans access to new products that are already widely available in other countries.

Ricardo to global health community - protectionism doesn't work!

In the ongoing battle to improve access to medicines in the poorest parts of the world, the global health community is resurrecting a ghost from the 1950s: the promotion and protection of local pharmaceutical companies, who can then supply home markets without the need for unreliable foreign suppliers.

This latest version of the hoary 'infant industry' protectionist trade policy comes with the backing of a medley of NGOs, UN agencies and even the World Bank.

It seems that the results of this protectionism are as suspect as the theory.  In this new paper from the CFD, author Roger Bate takes a look at the economics of subsidising local drug production, and finds that it gives rise to a whole host of unintended consequences. 

Most dangerously for patients, it seems that many local pharma cos  do not have the skills or capacity to manufacture drugs to international standards - raising the spectre of increased drug resistance or clinical failure (otherwise known as death).

It seems that trying to defy basic laws of economics -- such as comparative advantage and specialisation - -  not only costs more, but comes with a significant health risk. 

Not only that, handing the control of industry to politicians opens up all kinds of opportunities for corruption.

Surely it would make economic sense to simply import drugs from countries that have the skills to do it safely and cheaply?

Perhaps it is time to send these new protectionists back to Economics 101.

The real causes of ill health in Africa.

We were lucky enough to have the Ugandan John Kilama from the Global Biosciences Development Institute over for lunch today.

John argued that most of the debate about health in Africa, which focuses on such things as the cost of medicines and intellectual property, is totally wide of the mark.

In fact, the African healthcare crisis is completely homegrown.  John pointed out the egregious taxes and tariffs most African governments impose onto imported medicines, as well as the daedalean complexity of getting a new drug registered before it can be sold.

More fundamentally, a mixture of political and economic oppression, as well as general governmental incompetence, keeps most Africans poor and unable to afford the kind of living conditions that most of us enjoy in the west. This is the reason why diseases such as diarrhoea and  chest infections  kill so many.

It's great to hear Africans making these points.  John is going to be appearing on the BBC while he's visiting London, so do keep an eye out of for him.