The growing controversy over efforts to thwart counterfeit medicines has run into opposition from consumer activitists who complain some countries are blocking access to legitimate, lower-cost generics in the process. This is an issue in Europe and Africa, where the the East African Community (EAC) is considering an anti-counterfeit law. In an interview with the Inter Press Service, EAC secretary general Juma Mwapachu defends a policy that is criticized for blocking generics. This is an excerpt…

IPS: The EAC is in the process of adopting an anti-counterfeit policy and law. Why do we need this law?
Mwapachu: 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 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.

IPS: 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.
Mwapachu: First let me tell you that because of the threat of counterfeits, we estimate that our region loses billions of dollars per year due to counterfeits…We took a law firm from Kenya to do research in all five 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…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…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.

IPS: But the same draft has been circulated by the very consultants that you hired. How come you have not seen it?
Mwapachu: 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.

IPS: 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.
Mwapachu: 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.

IPS: Civil society’s concern is that the proposed policy seems to counteract the flexibilities as provided for under the World Trade Organisation’s TRIPS agreement.
Mwapachu: I am telling you that we are nowhere close to tabling that bill before the East African legislative assembly. Right now it is with the consultants. Incidentally, I have not seen the draft bill.

IPS: What role is the Investment Climate Facility playing in this process? The ICF is allegedly representing the interests of multinational companies opposed to accessible generics.
Mwapachu: That is a falsehood peddled by so-called civil society. We have a working relationship with the Investment Climate Facility which goes beyond the policy on fighting counterfeits. In partnership with the ICF we have embarked on another project to harmonise member states’ commercial laws as we prepare for the common market.

IPS: The concern is that the policy they have funded could trade away the flexibilities that LDCs are supposed to enjoy under TRIPS when it comes to patents and access to medicines.
Mwapachu: All our members have signed the WTO agreement. There is no way that we can have a regional law that contravenes an international law. Don’t (spread) fear among East Africans, particularly those who are suffering from this (AIDS) pandemic. This is creating unnecessary fears. As if we don’t have intelligent people…We are not going to contravene TRIPS, which is clear on generic medicines. How can we contravene and international law that our countries are signatories to? Impossible…I can assure you that we shall abide by international obligations, particularly TRIPS. I use generics because I cannot afford branded drugs. So I will be the last person to block their importation. I support access to medicines initiatives but not access to medicines (supplied by) stupid, silly businessmen who link up with obscure suppliers and they bring panadol extra, which is chalk, or metakalfin which is not proper metakalfin. They want to kill our people. No, no, I will not allow this kind of shoddy counterfeit imports to come and destroy the lives of our people.