My interview with Patrick Lukulay, Ph.D., Director, Promoting the Quality of Medicines (PQM) program at United States Pharmacopeia (USP) (a non-governmental organization dedicated to monitoring standards and quality of medicines and food around the world) touched on some of the political issues affecting the monitoring of quality of medicines in these countries. Excerpts follow.
He touched on the urban/rural divide and the neglect of rural populations by the centralized governments:
"That’s why people go there [the informal market] to buy, price is an incentive, also access is the next incentive. People in remote parts of the world, in these countries cannot travel to the capital city where you have the fancy pharmacies and you have the government depots. They will buy from the nearest vendor in their communities. Especially for malaria. If your child has a high fever, you’re not going to travel an hour to go to the capital city. You’re just going to get what’s nearest to your home. So access is one thing that has contributed to people buying from these remote or illicit markets as well as price."
He also commented on the Affordable Medicines Facility for Malaria program currently underway and supported by the Global Fund. This program reduces the price of malaria medicine for all distributors from the private, public and NGO sectors.
""There is a campaign now, launched by the global fund, know as AMFM, affordable medicines facility for malaria. This is a program that the global fund is launching to basically make ACTs available at very reduced price to both the public and the private sector. It’s an initiative I am aware of and the idea behind it is that when you make good quality products available nationwide and the price is low, then you crowd out the illicit markets and you crowd out the poor quality products because you don’t have the products all around. There are some people not quite in favor of the idea, but this is being done to increase access at the global fund level.
There have been arguments against this approach. The biggest argument is that by making these good quality medicines available or prolific around the countries that there is going to be irrational use of them so people are going to get them even without prescriptions and they may not be used in accordance with the directions for use of this product, that is one argument against it, and there is also the possibility that some of these might be pilfered from one country where it is introduced and sent to another country where it’s not yet introduced and sold at higher prices. So those are things that could happen, but the global fund is saying that we already have people buying poor quality products anyway and they are using them irrationally, so let’s try this scheme and see if more people get exposed to high quality medicines.
My personal opinion on it is that I can understand the pressure to do this but I am concerned that the efficacy of the medicines is more important than trying to do a quick fix approach now and be left with an ineffective therapy down the road. You know, so while you are clearly trying to reduce mortality if those products are not properly controlled, in the long run you end up losing the battle. Because this type has never really go away completely, you always need a therapy that you can introduce so by going on with this program and not ensuring that the efficacy of these medicines is going to be controlled properly there is a fear down the road that you could develop ineffective therapy for the malaria parasite."
Finally he talked about the political favoratism that complicates the ability of governments to take substandard medicines off of the market.
"Once a product is known to be substandard, the country has to have the political willingness to basically take action on this, irrespective of other factors. And so there is that dimension that has to be taken also into account. It’s not as straight forward as in the US where these type of actions are almost automatic. In these countries there are several considerations that they have to deal with to basically have the political willingness to go ahead and do the right thing.
In several countries there are political factors, I will put it that way, where businesses involved in this trade might have links in high places and the fact that these could influence whether actions are taken against these folks or not. The other one is the remoteness of several places in the country. So even access, rural access to several parts of the countries is not as challenging, so you almost have isolated provinces or villages where there is very little link or access between those places and the big cities so just getting around to going to these places also poses a problem so it all complicates matters."
