Falsified medicines in Ukraine: the issue requires immediate steps
Nowadays, the falsification of medicines is a global challenge. According to the data provided by the World Health Organization, around one in ten items for medical use is inferior or falsified in countries with a low or average income, which obviously includes Ukraine.
MBA, Attorney-at-law, Partner at Legal Alliance law firm
Law enforcement officials (in particular, the US and the EU) inform that, in fact, Ukraine has turned to be a centre for international trade in falsified medicines confirmed by investigations of recent years and, in particular, criminal cases involving Ukrainian citizens abroad.
Bearing this in mind, we need to develop a strong regulatory system and rules to enforce appropriate quality controls in order to protect the safety of the patients.
The 2D coding system is one of the key instruments to fight the falsified medicine turnover. A unique identifier (a 2-dimension barcode) allows the identification and authentication of the individual pack of the medicine, ensuring its safety and proper quality. From February 2019, the 2D coding system is implemented in the European Union countries. As to Ukraine, the Concept of the state policy to prevent the falsification of medicines and approval of the implementation plan has also been adopted. In particular, the introduction of a unified system for monitoring the turnover of medicines, as well as labelling of drugs with control identification signs based on 2D coding is planned. These safety features will guarantee that the medicine is not falsified, expired or imported into the country in violation of standards. However, the implementation of the 2D coding system is important but only one of the steps needed to reduce this illegal phenomenon.
Our research and analysis of the best world practices show that in order to truly reduce the amount of falsified and imported/exported medical products to/from Ukraine, it is vital to take the following regulatory steps:
1) To improve mechanisms to handle actions on recall, suspension, withdrawal and/or destruction of falsified medicines.
The Methodical Recommendations for Keeping Records of Medicines and Medical Devices in Healthcare Facilities, approved by the Order of the Ministry of Health of Ukraine dated September 09, 2014, No. 635 (hereinafter referred to as the Methodical Recommendations), should not only directly specify the actions to be undertaken with regard to expired medicines only, but also provide for the possibility of withdrawal and subsequent disposal of falsified medicines. Relevant amendments are required.
2) To authorize the inspectors to enter supply chain facilities at any reasonable time and in any place.
As a general rule, the business entity shall be notified in writing of the planned event not later than ten days before the day of this measure (part 4 of Article 5 of the Law of Ukraine “On the Basic Principles of State Supervision (Control) in the Field of Economic Activity”). Such leniency gives manufacturers an opportunity to prepare for the inspection and even destroy evidences (if needed).
Article 6 of the Law of Ukraine “On the Basic Principles of State Supervision (Control) in the Field of Economic Activity” envisages an exhaustive list of grounds for unplanned inspections. However, they do not include requests of law enforcement agencies, manufacturers/owners of registration services or their representatives on the territory of Ukraine, or other legal entities.
Furthermore, an appeal submitted by an individual(s) against the violation that caused damage to his/her (their) name, legitimate interests, life and health, environment and safety state is subject to approval of the Ministry of Health of Ukraine. Although this procedure filters unfounded appeals, it reduces the ability of individuals to report falsified medicines. It may also pose some potential corruption risks.
Only the Prime Minister of Ukraine may authorize the inspection of business entities in the relevant field in connection with the identified systemic violations and/or the occurrence of an event that has a significant negative impact on rights, legitimate interests, human life and health, environmental protection and state security.
Herewith, the EU legislation provides for that prior announcement of the inspection may be given but is not necessary. Therefore, respective changes should be implemented into the Ukrainian legislation in this regard.
3) To introduce adequate regulations on cooperation and exchange of information between the different branches of law enforcement.
The effective legislation of Ukraine does not ensure clear coordination, cooperation and the exchange of information among the National Police of Ukraine, the Security Service of Ukraine, the State Fiscal Service and the Ministry of Health of Ukraine. For instance, there is a lack of cooperation between the State Fiscal Service customs and State Medicines Service.
Due to the contradictory legislation, the State Customs Service of Ukraine does not submit to the State Medicines Service information on medicines imported into Ukraine. It should also be noted that such information concerns only official import of medicines. In addition, some State Medicines Services do not have the ability to automatically verify the data on imported medicines.
In this respect, in order to ensure the cooperation and exchange of information between the different branches of law enforcement, respective changes should be implemented into the legislation of Ukraine. This can be achieved by following the Swedish experience with establishing an analogue of the Centre against Illegal Medicines.
4) To draft regulations to conduct targeted inspection of medicines at designated border points.
Targeted inspections of medicines at designated border points are not envisaged in the effective legislation. In this vein, there is a need to enable coordination between the State Customs Service of Ukraine and the State Medicines Service. Respective changes should be implemented into the Ukrainian legislation with this regard. As an example, an American experience with monitoring mail importations of FDA regulated products may be taken as a model for implementation into Ukrainian legislation. Additionally, WHO GLOBAL BENCHMARKING TOOLS may also serve as a ground for establishing targeted inspection of pharmaceutical goods at border points, where samples could be taken for analysis where appropriate.
5) To regulate market control activities including testing of medicine throughout the whole supply chain and Internet sales.
Amendments are needed into the Procedure for the State Quality Control of Medicines imported into Ukraine, approved by the Resolution of the Cabinet of Ministers of Ukraine dated September 14, 2005, No. 902, to ensure that not only the batches of medicines imported into Ukraine for the first time are tested in the laboratories.
Internet sales are regulated by the new (recently adopted) law which is not implemented so far. This area also requires specific bylaws and implementation practices to ensure respective market control.
6) To implement adequate and proportional sanctions, penalties and prosecutions for violations of the applicable legislation.
The notion of the “falsified medicine” defined in the effective legislation does not correspond to the legislation of the EU and most countries of the EU (e.g. Denmark, Germany, Austria, Croatia, the Czech Republic, Estonia, Finland, Belgium, France, Bulgaria, Cyprus, Greece, Hungary, Ireland, Italy, Latvia, Lithuania, Luxembourg, Malta, the Netherlands, Portugal, Romania, Slovakia, Slovenia, Spain and Sweden), as well as the legislation of Canada, Japan and Great Britain.
There is also a consensus at the WHO level that the registration of medicine (its market authorization in the particular state) is not a compulsory condition for regarding it as the falsified or unfalsified one.
There is a need to amend Article 321-1 of the Criminal Code of Ukraine in part of requirements, i.e. exclude the deliberate character of falsification, and the purpose to sell should become an aggravating circumstance. At the same time, there is a lack of administrative and civil responsibility for relevant breaches of law and misdemeanors, specifically for health care professionals.
7) Oversight by the authorities of medicines stored in bonded warehouses and customs zones.
Respective amendments shall be based on the provisions of the Guidance on the occasions when it is appropriate for competent authorities to conduct inspections at the premises of manufacturers, importers and distributors of active substances and manufacturers or importers of excipients used as starting materials.
Summing up, in order to truly reduce the falsification of medicines we need to implement best world practices and focus on the key steps towards the development of a strong national regulatory framework.