On May 18-21, in Kyiv, a three-day workshop was held by the U.S. Department of Commerce Commercial Law Development Program (CLDP) on identification and interdiction of counterfeit medicines. In the course of the workshop, CLDP utilized expertise from international organizations, NGOs and private industry associations. The workshop aimed to increase the understanding of Ukraine’s officials, specifically its law enforcement and regulatory agencies, of the most effective methods and techniques to combat the trade in counterfeit medicines.
The objectives of the workshop were to identify key legislative and institutional impediments to adequate and efficient enforcement to counteract the trade in counterfeit medicines in Ukraine; promote increased coordination between industry representatives, consumers, NGOs, government regulators and law enforcement agencies – judiciary, prosecution, investigators and customs officials; and to provide information about technical solutions – such as trace and track technologies – to combat the threat of counterfeit medicines.
Ukrainian participants included investigators, prosecutors, judges, customs officials, government regulators, NGOs, and private sector representatives. United States Government speakers included Hon. Danny J. Boggs, Judge, U.S. Courts of Appeals for the Sixth Circuit; Samuel Louis, Assistant U.S. Attorney, Southern District of Texas; Kevin Rosenbaum, Attorney-Advisor, Office of Policy and External Affairs, USPTO; Robert Sherman, Special Agent, Homeland Security Investigations, U.S. Immigration and Customs Enforcement; and Wade Ackerman, Associate Chief Counsel, U.S. Food and Drug Administration.
As the Ukrainian and American specialists pointed out during their statements, counterfeit medicines are a growing threat across the globe. A medicine is counterfeit if it is “deliberately and fraudulently mislabeled with respect to identity and/or source”. counterfeit medicines are always substandard, and frequently an infringement on the intellectual property rights of legitimate manufacturers. It is estimated that as many as 10 percent of medicines in the world are counterfeit, up to 25 percent in developing countries, a number that will only increase without legislative and regulatory enforcement and increased public awareness.
Ukraine acceded to the World Trade Organization (WTO) in 2008; it is also a member of the World Health Organization. WTO law, among other issues, includes requirements regarding the steps every member must take in order to combat the distribution of counterfeit drugs. This not only protects the commercial interests of stakeholders, and thus stimulates further pharmaceutical research, but also ensures that national health is protected from severe dangers arising out of consumption of counterfeit medicines.
Ukraine’s regulatory system is not focused on the evolving dangers of counterfeit medicines, particularly those manufactured and sold in Ukraine. There are a number of legislative acts in Ukraine containing regulations on how to combat the trade in counterfeit medicines and though Ukraine has succeeded in shutting down some pharmacies that sell counterfeit medicines, the legal system lacks the capacity to identify, contain, and effectively prosecute counterfeit goods and those who make and market them. According to evidence from the private sector, consumers and Ukrainian non-governmental organizations (NGOs), some enforcement measures are too mild, such as criminal punishments for the sale of counterfeit goods, whereas other measures seem excessive, for example, the rigorous inspections at the border.
Moreover, there exists a low level of coordination between industry representatives, consumers, NGOs, government regulators and law enforcement agencies which has resulted in inadequate and insufficient combating of counterfeit medicines in Ukraine.
The first day of the workshop examined the challenges of counterfeit drugs both globally and in Ukraine, and the regulatory systems that can help to prevent counterfeit medicines from making their way into pharmacies and into the hands of consumers. The second day focused on investigation, prosecution and adjudication of criminal cases involving counterfeit medicines, intellectual property infringement aspects of counterfeit medicines, and reinforced enforcement procedures and methods through an interactive country-specific case study. Finally, the third day of the workshop featured a panel of private sector representatives and provided information on various traceability technologies.
In summing up the outcomes of the workshop, its participants underscored that this is a very topical and timely issue. They also underlined the high professional level of the discussion and expressed their certainty that the workshop would increase the adequacy and efficiency of law enforcement agencies to combat the trade against counterfeit medicines in Ukraine, serve to increase the confidence of consumers that medicines are legitimate and safe, increase the flow of investment from the private sector into the pharmaceutical industry, lessen the burden of complying with trade regulations for businesses involved in trade with legitimate medicines and increase the efficiency of IPR enforcement in Ukraine.
Background on CLDP
Created in 1992, the Commercial Law Development Program (CLDP) is a program of the U.S. Department of Commerce Office of the General Counsel that is uniquely tasked with providing technical assistance in the commercial law arena to the governments and private sectors of transitional countries in support of their economic development goals. CLDP assists transitional countries by providing training and consultative services to government representatives, lawmakers, regulators, judges, lawyers, educators and other stakeholders.
As part of the U.S. Government’s technical assistance to Ukraine, CLDP has been tasked by the U.S. Department of State to provide technical assistance to Ukraine in the Domain of solutions to the public health threat of counterfeit medicines and the infringements of intellectual property rights (IPR) that accompany this problem.