Will African patients have access to quality medicines in the future?

Two different experiences with medicines are having a great impact on public health inAfrica: one positive, the other negative. The positive one is the improved access to antiretroviral (ARV) medicines, as a result of the introduction of generic ARVs and the impressive drop in their price due to competition. On the negative side is the availability of fake medicines on the African markets and street kiosks. These are causing death or worsening the condition of the patient. If countries try to fight the fake medicines purely by defending intellectual property protection, they may endanger the benefits of generic medicines.

 

The benefit of generic medicines

 

When antiretroviral medicines (ARVs) appeared on the market, their high price made them inaccessible to most Africans. Only the rich HIV/AIDs patients could afford them. The introduction of generic ARVs meant a revolution in HIV/AIDS treatment, as they brought in competition between generic and branded marks. As a result of this competition the cost diminished from $ 10,000 per year to the current treatment costs of about $100 per year. This allowed 3 million patients globally to be treated with ARVs. The introduction of generics in Africa was greatly aided by the work and lobbying of civil society inAfrica.

 

What are those generic medicines (in short: generics) that caused such a revolution by lowering the price of branded medicines? Generics are medicines produced and distributed without a patent. Generics contain the same active ingredients as the original formulation. Generic drugs are identical to the brand name counterpart with respect to the pharmaceutical properties. Therefore, generics are identical in dose, strength, route of administration, safety, efficacy, and intended use to the brand medicine. Their effect is the same but their price is much lower. In many countries doctors prescribe mainly generics, because of their lower cost.

 

In most cases, generic products are available once the patent protections afforded to the original developer have expired. But in the interest of public health, countries may decide on a “compulsory license” to produce or import a medicine that is still under patent. In both cases the generics are legal, which means they have the right to be produced and sold in the countries where the brand medicine is not patented. Some laboratories in Europe, Asia andAfricaproduce generics of quality. When generic products become available, market competition leads to substantially lower prices for both the original brand name and the generic forms.

 

Today access to generic medicines of quality is in danger.  This is due not only to the patents and the difficulty countries have in declaring “compulsory licenses” when faced with the interests of the pharmaceutical companies but, even more, to a subtle strategy that deliberately creates confusion between “counterfeit” and “generic” medicines. This is why is important to make the distinction between the different concepts and realities relating to quality medicines.

 

Controlling “knowledge” and its effect on health

 

In globalisation “knowledge” is one of the main market assets. Enterprises and states that possess “knowledge” (technical, scientific, intellectual, etc) protect it, and oblige others to pay for using it or benefiting from it.  Patents are part of this “intellectual property protection”. Companies dispose of different means to protect their knowledge and their production: patents, copyright, trade-marks, etc. The result of this protection is goods whose price greatly exceeds their production costs, where we pay for the trade-mark or the brand name.

 

When, after research and clinical tests, a new medicine appears on the market, the owner obtains a patent from the state where the medicine has been developed. In exchange for the disclosure of the invention, the patent owner obtains exclusive rights to production, sale, export and pricing of this medicine for a limited period of time (10 to 20 years). The patent denies others the right to perform these same actions or to acquire the same benefits. The medicine under patent is called a brand medicine. The huge difference between the cost of production and the selling price is meant to cover the cost of research, as reported by the company producing it.

 

The danger in medicines, like in any other branded product, is that others will produce a copy of the product, making it appear like the “real one”. This is called “fake” or “counterfeit”. The global market of counterfeit goods is growing and fake Rolex watches, Levi jeans, DVDs and thousands of articles, resembling the branded mark but of inferior quality, are available at lower prices than the originals. The owners of the “trade-marks” or “brand names” fight against this phenomenon as it reduces their profits.

 

To fight against this illegal trade of fake goods, a group of industrialized countries are negotiating in secret the “Anti-counterfeit Trade Agreement” (ACTA) that will enforce “knowledge protection” and all intellectual property rights. To fight the invasion of counterfeit goods,Kenya andUganda have also adopted counterfeit legislation. The danger is that, under the guise of fighting counterfeits, these countries will strengthen the protection of intellectual property rights. These laws often focus more on the protection of private property rights than on public interests such as safety.  In the case of medicines, this enforcement agenda comes with serious public health costs, as it can affect access to generic medicines in countries of the South.

 

Counterfeit medicines harm health

 

While quality generic medicines facilitate access to medicines for all, counterfeit medicines are causing great health problems in Africa. Counterfeit medicines are a danger, not so much because they do not respect patents, but because they do not conform to quality standards, thus jeopardizing the health of the users who are mainly in developing countries.


When the prices of medicines become excessively high and unaffordable, patients tend to look for cheaper sources. This encourages counterfeiters to produce cheaper counterfeit drugs, and consumers to seek medicines outside the normal supply system, putting in danger their health and the health of the community.

 

Fake and counterfeit medicines constitute today a vast and growing market, generating abundant profits. They are a serious and growing problem in Africa. The consequence of this illegal trade is that millions of people are unwittingly consuming talcum powder, sawdust, paint and an array of other toxic or inert substances, believing they are taking good medicine. Fake medicines ruin efforts to cure disease and aggravate illness, and worst of all, it results in the emergence of drug resistance to diseases ranging from AIDS and malaria to tuberculosis. African markets and shops are full of fake medicines that have the appearance of “ordinary and good drugs”. There is great danger in buying unpacked drugs, on the street and markets, sold by non-pharmaceutical staff. 


A counterfeit medicine is produced and sold with the intent to deceive regarding its origin, authenticity or effectiveness, e.g. when it is falsely labelled, with the trademark (distinctive sign that identifies the product) of another company, inappropriate packaging, poor manufacturing processes, and improper conditions during transportation and storage. At the point of purchase, such drugs are not what they declare to be, because they include the wrong ingredients, or have no, or not enough, active ingredients (the substance that is pharmaceutically active).

 

But the problem of access to quality medicines is complicated by the lack of quality control of the medicines in exporting countries, and the lack of guarantee control in the importing countries. This facilitates the export of substandard medicines to Africa. These are genuine, legal and authorized medicines which do not meet quality specifications as they do not contain the right quantity or quality of active ingredients. Consequently they are ineffective and often dangerous to the patient. Substandard products may occur as a result of negligence, human error, insufficient human and financial resources, or lack of control.

Substandard and Counterfeit medicines have no therapeutic benefits and are a real danger in Africa. They are a major reason why over the past 30 years, malaria, once an illness that could be easily treated with medicines, has become Africa's biggest child killer. As some fake drugs contain no medicine at all, or only tiny traces of the real active ingredients, this allows the malaria parasite to build up resistance to the drug. Of the one million deaths that occur from malaria annually, as many as 200,000 would be avoidable if the medicines available were effective, of good quality and used correctly.

 

Because of a lack of regulation and enforcement, the quality, safety and efficacy of both imported and locally manufactured medicines in many developing countries cannot be guaranteed. This is why AEFJN with other international organizations has established the Charter for the Quality of Medicines, an ethical code for the buyers of medicines, offering them landmarks for quality medicines so that they can be sure of the quality of the medicines they buy. Signing it implies a commitment to adopting essential quality criteria for the purchase of these products, thus contributing to the setting up of a Quality Assurance (QA) system for medicines.

 

Begoña Iñarra

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