Medicines Safety testing: From negligence to fraud

Fake and counterfeit medicines are one of the most vulnerable places in the health care system in Ukraine and not only in Ukraine.

The main factors in the production and sale of counterfeit medicines in Ukraine are the uncontrolled growth of the pharmaceutical market, as well as a rather low level of law enforcement, which also does not facilitate to clear the market from counterfeiting.

As a result, the impunity of such manufacturers and the high cost of imported medicines create the ground for selling counterfeit pharmaceuticals.

Furthermore, it should be noted, inadequate implementation of good pharmacy practices, which also contributes to the uncontrolled growth of industries and distribution channels of medicines and the low level of copyright protection in Ukraine, does not allow to use producers themselves to combat trafficking and counterfeit flows.

The problem of trafficking of counterfeit medicines on the Ukrainian market is becoming a national disaster every day, as evidenced by the profitability of the pharmaceutical market, which ranks third after the sale of arms and drugs.

You may ask what do counterfeit medicines / drugs menace with?

First and foremost, they pose a risk to life and health of people, as their contents may be dangerous or they may lack active ingredient, with the consequence that such medicinal drugs / remedies can lead to treatment failure, entail a threat to the health or even life of people.

Counterfeit medicines can be conveniently divided into three groups:

Preparations – pacifiers.  Such drugs can be attributed to the safest for humans, due to the lack of active substance in them;

Drugs- imitators.  They have replaced the main active substance with a cheap analogue.  Such drugs can be attributed to the most dangerous counterfeit, which may well be fatal.  This group includes medicines / drugs in which the active substance is less than the original, as well as drugs – replicates that externally replicate the products of other manufacturers;

Medicines with an expired life and reglued labels.

It is also worthwhile to pay attention to the statistical side of the problem, according to which the counterfeiting of medicines is the fourth evil of the global health system after malaria, AIDS and smoking.

Mortality rate due to adverse reactions of drugs / pharmaceuticals, comprise the top five reasons along with cardiovascular, cancer, respiratory diseases, and accidents.

At the beginning of the 2000s, generally recognized EU standards of good manufacturing, distribution, clinical, laboratory practice were approved in Ukraine, some time later – good pharmaceutical (pharmacy) practice, good regulatory practice and pharmacovigilance practice were approved as well.

Implementation of all these practices in the sphere of circulation of medicines could guarantee their safety and quality, meet the needs of the national health system and each patient’s medication.

But in reality, all turned out contrary to one’s desires.

According to the world health organization, the proportion of counterfeits in the countries of Western Europe is only about 5 – 8%, which is significantly lower than in Ukraine.

So, what is the reason for such high rates in our country?

In my opinion, such indicators have to do with the low quality of the legal framework and corruption in the bodies that control this activity.

To resolve the current situation, it would be advisable to offer a series of consistent actions that can facilitate reducing the proportion of counterfeit and smuggled medicines.

First of all, it is necessary to strengthen the control over the law enforcement, fight against corruption in the local areas, as well as  introduce new legislation on market and consumer protection.

In particular, one needs to carry out an inspection of the farmaceutical companies of Ukraine for compliance with the standards and requirements of Good Manafacturing Practice (hereinafter GMP).

GMP or good manufacturing practice, that is, rules that set requirements for the organization of production and quality control of medicinal drugs for medical use.  As for the process of state registration of medicines, it is my deep belief that it is at this stage that the lion’s share of the state’s attention should be paid.  To do this, the rules of expert’s review of the registration materials need to be strengthened, while relying on the benefit / risk ratio for the patient. Only strict adherence to the requirements of the Law and the practices envisaged, from the stage of pharmaceutical development to distribution, can ensure the safety and quality of medicines in a global sense.  Thus, since medicines directly affect patient safety, virtually all pharmaceutical business rules and conditions shall be as transparent as possible and binding on all pharmaceutical market participants, while effective compliance monitoring is the responsibility of the state.  It is the duty of the state to uphold the right to health of every citizen – including by allocating “maximum available resources” to progressively achieve this goal.

So, we hope that respect for human rights will be a priority for the state and will become a solid foundation for all its citizens.

– Darya Vasina, the lawyer of “Dynasty” Law Firm.

 

Publications 27 September, 2019

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