Q&A: Anti-Counterfeit Policy Will Provide 'Proper' Generics
The anti-counterfeit draft policy and law that the East African Community (EAC) is currently considering will ensure access to 'proper' generic medicines and not fakes, EAC secretary general Juma Mwapachu says in defence of a policy which is criticised as blocking affordable and legitimate generic medicines.
'Social activists who call themselves civil society' should realise this, Mwapachu cautions.
In this interview with IPS’s Wambi Michael, he also complains about civil society activists getting hold of the draft policy and admits to finding generic medicines 'confusing'.
Q: The EAC is in the process of adopting an anti-counterfeit policy and law. Why do we need this law?
A: Counterfeits are a huge threat in several ways, the key one being the health of our people. We have container loads in Kenya and Tanzania ostensibly containing anti-malarial drugs when in fact there is nothing. In Tanzania they said it was metakelfin (which it wasn’t). It was some kind of chalk.
In Kenya it was (the pain stiller) panadol extra (which), when taken to the Kenya Medical Research Institution, (was) found to be chalk.
Counterfeits, if we are not careful, will be a death blow to our people. I really want the East African people (to know this), particularly social activists who call themselves civil society and are trying to argue against the law that we are trying to bring about at EAC level, saying that generics are going to be stopped because of this law against counterfeits.
The counterfeits law will ensure that we do get generics, including the ARV (antiretroviral) generics, but (we will get) proper generics and not this kind of metakelfin and panadol extra which is chalk and ends up destroying the lives of East African people. Number two, these counterfeits are charged very low taxes at Mombasa and Dar es Salaam ports. There is under-declaration and therefore our governments are losing a lot of revenue. Those are the two key issues that people in East Africa should understand.
Q: The concern is that the law is drafted in such a way that it would undermine access to generic medicines consumed by over 90 percent of patients in East Africa.
A: First let me tell you that because of the threat of counterfeits, we estimate that our region loses 600 billion dollars per year due to counterfeits.
Q: Is that based on scientific facts?
A: Quite right. We took a law firm from Kenya to do research in all five the member states. They have even done validation exercises to establish the mammoth nature of the counterfeits problem. Then we came up with a policy document.
Q: Is that the East African anti-counterfeits draft policy?
A: Exactly. And each of the member states is initiating different types of laws. Some have some kind of law (in place) but none of these laws are robust enough really to counter this huge problem. And you must understand that counterfeits cross borders.
Someone imports so-called metakelfin in Tanzania and re-exports it to Burundi or Rwanda. So they are transferring the problem and we have to address it with a regional law. We are now considering the draft bill. We have not finalised it.
Some of these things that I read in papers that we are trying to fight generics… I don’t know what the source is because this bill has not been discussed by our council of ministers and has not been tabled before our legislature.
Q: But the same draft has been circulated by the very consultants that you hired. How come you have not seen it?
A: Fine, but there is the East African legislative assembly and the attorney generals and our ministers of justice that have not gone through this bill. They will go through this bill and see whether the provisions will in any way affect the importation of generic ARVs or any other drugs.
But (what) the social activists are not telling you, is whether the counterfeit ARV generics have got the potency.
Q: They are actually opposed to fake or substandard drugs. They are saying the draft policy seems to mix issues of intellectual property enforcement with quality.
A: The word 'generic' is confusing. We have seen it in the case of malaria drugs in the region. Why should there be ARV generics that have only two to 10 percent potency? You will not cure your people.
*This is the first part of a two-part interview.
© Inter Press Service (2010) — All Rights ReservedOriginal source: Inter Press Service