Kyiv, June 11-12, 2013. Council of Europe and State Administration of Ukraine on Medicinal Products (SAUMP) had conducted a two-day International Conference: Towards the practical implementation of the Council of Europe Convention on counterfeiting of medical products and similar crimes involving threats to public health (MEDICRIME Convention).
In 2011, Ukraine was among the first countries signed the MEDICRIME Convention. Ukrainian Parliament had ratified the Convention during the summer 2012 session and after that it acquired the status of law. That is why Ukraine was chosen by the Council of Europe as host country for the International Conference which was aimed to:
- raise awareness among members of parliament, law enforcement, NGOs, the media and professionals working in the field;
- exchange information on counterfeiting of medical products and similar crimes;
- present Ukraine’s practical steps towards implementation of MEDICRIME Convention;
- exchange experiences, know-how and networking of law enforcement, regulatory authorities of foreign countries and international organizations, including the Parliamentary Assembly of the Council of Europe, responsible Directorates of the Council of Europe, the World Health Organization, etc.
Incidences of counterfeit medical products and similar crimes are among the current issues of international community. Counterfeiting of medical products and similar crimes have a global spread, no country is spared.
Counterfeit medical product and similar crimes are dangerous because:
- the quality of the product is unverifiable: unexpected toxicity may come from the active ingredients, the excipients or the packaging (unsuitable plastic or glass);
- even if illegal products contain the same ingredients as the original product, uniform distribution of those ingredients is never guaranteed. Some batches may therefore have an excessive or insufficient dose of active ingredients;
- inappropriate storage conditions may lead to deterioration of the product;
- the lack of active ingredients is also a danger because the patient will be using an inactive medicine instead of a treatment appropriate to his or her condition;
- a counterfeit medicinal product is a silent killer and the consequences for the patient may be fatal;
- the use of counterfeit or illegally manufactured medicines deprive legal industry of revenues.
The MEDICRIME Convention was opening for signature in October 28, 2011 in Moscow. As of today 22 countries had signed the Convention including Austria, Belgium, Armenia, Côte d'Ivoire, Denmark, Israel, Iceland, Spain, Italy, Cyprus, Liechtenstein, Luxembourg, Morocco, Moldova, Germany, Portugal, Russian Federation, Turkey, Ukraine, Finland, France, Switzerland.
The Council of Europe has drawn up the first international treaty against counterfeit medical products and similar crimes involving threats to public health, the MEDICRIME Convention, to establish as offences:
- the manufacturing of counterfeit medical products;
- supplying, offering to supply and trafficking in counterfeit medical products;
- the falsification of documents;
- the unauthorised manufacturing or supplying of medicinal products and the marketing of medical devices that do not comply with conformity requirements.
The Convention also lays down a framework for national and international cooperation between the competent health, police and customs authorities on both the national and international levels, measures for crime prevention by also involving the private sector, and the effective prosecution of crime and the protection of victims and witnesses.
Ukraine has adopted laws aimed at compliance with the requirements of the MEDICRIME Convention.
Particularly Ukraine adopted in 2011 and in a year enhanced criminal liability for falsification of medicines.
All SAUMP territorial divisions have special regional programs aimed at prevention of import and distribution of substandard, counterfeit and unregistered medicines in each country region. Permanent working groups were created from representatives of SAUMP, law enforcement and customs to trace pathways of counterfeit medicines.
This year Ukraine will start a pilot project of manufacturers medicines labeling introduced by SAUMP. This project will secure the legal supply chain from the counterfeit medicines and will enable teal time medicines identification.
You can find full text of MEDICRIME Convention HERE.