Three new bills have recently been adopted that have implications for the pharmaceuticals industry. These bills have: (i) introduced new rules for pharmaceuticals import licensing; (ii) restricted the rules for interactions between health care practitioners and pharmaceutical companies; and (iii) toughened the sanctions that may be imposed on those who violate the regulations governing clinical trials.
Pharmaceuticals import licensing
The Law "On Amending Certain Laws of Ukraine on Licensing Of Import of Pharmaceuticals and Defining the Term "Active Pharmaceutical Ingredient", dated 4 July 2012, has introduced significant changes to the rules for the import of pharmaceuticals, including:
- from 1 March 2013, the import of pharmaceuticals into the Ukraine will require a separate licence;
- from 1 January 2013, the import of pharmaceuticals into the Ukraine will be allowed provided that (i) the remaining period of the medicine's shelf life is not less than half of the total shelf life period if the shelf life is under one year; and not less than 6 months where the total shelf life is more than one year; and (ii) a quality certificate for a given batch (batch release) by the producer is provided; and
- a new definition of the active pharmaceutical substance has been introduced into the Law of Ukraine "On Medicines", and from 1 January 2015, the import of active pharmaceutical substances will require a separate licence.
The Law is due to become effective the day after its official publication (which is expected to occur shortly).
Only Ukrainian legal entities are eligible to apply for licences for importing pharmaceuticals and/or for importing active pharmaceutical substances. Foreign pharmaceuticals manufacturers currently without a subsidiary in the Ukraine may consider establishing such a subsidiary to apply for the necessary licence(s). Current importers (distributors) should be encouraged to apply for such licences well in advance to ensure that there are no delays in the supply of the manufacturer’s products into the Ukraine after the relevant import licence requirements take effect.
Restrictions on interactions between health care practitioners, pharmacists and manufacturers
From 1 August 2012, healthcare and pharmaceutical professionals will be prohibited from all of the following:
- receiving unlawful gains from entities (or those entities' agents) that produce or sell pharmaceuticals or other products with medical purposes;
- receiving samples of pharmaceuticals, of other products with medical purposes from business entities (or those entities' agents) that produce or sell pharmaceuticals or other products with medical purposes, except in relation to clinical trials;
- advertising pharmaceuticals or other products with medical purposes, including prescribing pharmaceuticals on forms that contain advertisements or indicate specific producers (brand names); and
- during retail sales, withholding from a customer information as to the availability in the pharmacy of a cheaper pharmaceutical with the same active ingredient (according to the international unpatented name), form and dosage, or providing such information that is misleading (this rule applies only to pharmacists).
The changes have been introduced by the Law "On Amending the Fundamentals of Legislation of Ukraine on Health Care on the Introduction of Restrictions on the Health Care and Pharmaceutical Practitioners' Performance of their Professional Activities", dated 4 July 2012, which will become effective on 1 August 2012.
Toughening the responsibility for violations of the pharmaceuticals regulations
The Law "On Amending Certain Laws of Ukraine on Toughening the Responsibility for Counterfeiting of Pharmaceuticals and Counterfeited Pharmaceuticals Trafficking", dated 5 July 2012, introduces a number of changes to the Ukrainian Code of Administrative Violations (Administrative Code) and the Ukrainian Criminal Code (Criminal Code). These changes will become effective after official publication (expected soon).
Amendments to Art. 442 of the Administrative Code effectively provide that non-compliance by pharmaceutical or healthcare professionals with the restrictions imposed by the legislation for their professional activities will be punishable by a fine equivalent to 300 times the non-taxable minimum income of citizens amount (approximately USD$630). Any repeated violation committed within one year after the first violation will be punishable by a fine equivalent to 1200 times the non-taxable minimum income of citizens amount (approximately USD$2,521).
Article 305 of the Criminal Code has been amended to increase the length of the prison terms that can be imposed for those convicted of smuggling counterfeit pharmaceuticals. Such actions will be viewed on par with smuggling narcotics, psychotropic substances, their analogs or precursors or counterfeited pharmaceuticals. The length of prison terms that may be imposed for this crime will now range from 3 to 20 years. The imprisonment periods for smuggling narcotic drugs, psychotropic substances, their analogs or precursors or of counterfeited pharmaceuticals is to be increased from 3 to 12 years to 5 to 20 years.
Under the amended Article 3212 of the Criminal Code, a breach of the established procedures for the conduct of pre-clinical trials, clinical trials or state registration of pharmaceuticals will be punishable by imprisonment terms ranging from 3 to 10 years (up from the previous maximum of 8 years).
Sanctions for counterfeiting of pharmaceuticals and for sales of counterfeit pharmaceuticals (the crime envisaged by Article 3211 of the Criminal Code) will no longer include fines as one of the possible punishments. Instead, the length of imprisonment terms that may be imposed will be increased such that the minimum prison term will be 3 years and the maximum will entail life imprisonment. The requirement that harm should have been caused by such actions to constitute the crime will no longer be an essential component of the crime.