Med. pravo., 2017; 1(19): 37-46
PhD, assistant professor, Department of civil, economical and administrative law, Poltava's Institute of Law National Law University of Yaroslav the Wise
The Legal Basis of Selling Drugs Containing Codeine
In the article were investigated features of legal regulation of drugs containing codeine in Ukraine and different countries of the world, including a procedure for delivery of drugs, such restrictions on their sale without a prescription, demarcated medicines containing narcotic substances and classic drugs. Clarified the basic rules governing these relations in accordance with international regulations.
The problem of medical drugs containing narcotic substances, their analogues and precursors is difficult, given the conflict of interest of the pharmaceutical business and law enforcement agencies. Also each state has a task to protect public interests. On the one hand, the pharmaceutical lobby has a significant impact on public policy in health care, because there are ineffective drugs and those that cause dependence often come to the market, or state bodies set them insufficient controls. On the other hand, it is unacceptable to restrict the circulation of the combined drugs containing codeine in small quantities, as the right of citizens on health care must be ensured.
Article provides a comparative legal analysis of the characteristics of normative regulation of medicines containing codeine in Ukraine at the international level, and in different countries.
Some aspects of legal regulation of drugs marketing have been studied by scientists such, as A. Simmons, E. Prommer, G. Ricaurte, UD. McCann, S. Smith, K. Schroeder, T. Fey, C. O'Connell, T. Nordehren, K. Nicholson, C. Mangham, J. Seguin, C. Straube, S. Derry, K. Jackson, P. Wiffen, R. Bell, S. Strassels, S. Straube, E. Wood, M. McKinnon, R. Strang, P. Kendall and others. However, despite the dire urgency of the matter, at the academic level problems of legal regulation of sale of medicines containing narcotic substances komlpeksno not been investigated.
In the Single Convention on Narcotic Drugs was provided a liberal (simplified) approach to the regulation of narcotic drugs circulation. Though, countries can adopt it in national laws. In particular, Art. 30 of the Convention provided that parties can determine that the sale of drugs and their distribution carry out under license. However, drugs (schedules 2 and 3 of the List) are subject to the same control measures as the Schedule 1 with the exception of measures envisaged in paragraphs 2 and 5 of the Art. 30 of the Single Convention on Narcotic Drugs. In these paragraphs fixed as follows: (1) state control of all persons engaged in trafficking of drugs; (2) monitoring by means of licenses. So, licensing requirements may not apply to selling of drugs and states have the right to determine the mandatory labeling of drugs by a double red stripe. Thus, the external packaging of the narcotic drug should not contain this band.
It is necessary to highlight some outstanding features of combined codeine drugs in different countries.
In Australia only pure codeine (codeine phosphate) is under a strict state control. Combined drugs which contain codeine in number of 15 mg / 1 dosage pharmacies can sell without prescription under the supervision of a pharmacist, with the exception of cold remedies. In Canada combined drugs which contain codeine in number 8 mg / 1 dosage pharmacies can sell without prescription. However, these drugs may not be placed on the windows of pharmacies. In Romania this numeral is set at 15 mg / 1 dosage. In France the major part of codeine drugs also vend freely. In Hong Kong the OTC form of release is set for combined drugs which contain codeine in number 5 mg / 1 dosage. Violation of prescription rules entails a big fine (between 10 thousands and 5 millions of HK dollars). In the USA cough medications containing codeine are considered as potent and prescription.
In Iceland, Spain, Germany, the United Arab Emirates and India all medicines containing codeine distribute under a prescription. However, in India cough medications are prohibited to sell, given the lack of conclusive results of effective use of them. In Germany local authorities can provide non-prescription regime. By the way, in the EU cough medications with codeine are not recommended for children under the age of twelve. In the UK drugs containing codeine sell out with prescription, except combined ones, in which codeine content should not exceed 12.8 mg / 1 dosage. In Ireland on this occasion were introduced the following specific rules: codeine medicines may not be placed on the shelves of pharmacies and pharmacist has a right to offer them to a consumer, unless he calls the name of a specific drug. Thus, consumer should be explained to all possible side effects. Since 2014 South Africa introduced an interesting pilot project: - there was completed a database of «abused substances», and the central database of all purchases containing codeine; - buying OTC consumer must inform pharmacist about his personal data, including identification code.
For improvement of legal regulation of drugs marketing we offered the following ways: - presentation of regulatory requirements on the basis of the principle of legal certainty and consolidation of legislation; - setting high penalties for violations of prescription drugs circulation for pharmacists (administrative responsibility) and entities (economic responsibility); - creation of a database of substances that are abused: if consumer buy OTC, he will notify personal data to pharmacist; - clear separation of pure drugs and medications that contain drugs; - higher prices for drugs that cause addiction.
The United Nations Convention on Narcotic Drugs gives countries the right not to recognize combined preparations containing a small amount of drugs, narcotics, and to release them without prescription. On this basis a number of countries which introduced appropriate legal regulations are: Denmark, Canada, Australia, the UK etc. If the consumer is released increasing number of such dosages (several blisters), it is not a basis for classifying the act as selling narcotic drugs.
The main tendency nowadays is deregulation and decriminalization of drugs circulation, particularly injected of them. However, the danger of humans addiction exists for drugs that were excluded from the scope of measures of international control under the Single Convention on Narcotic Drugs. New drugs which contain substances not included in the relevant lists are also very dangerous.
In the context of fighting against drugs counter pharmacy drug prohibitions are not effective measures. This policy must be carried out systematically at the level of prior public programs through education and raising living standards, infrastructure for active leisure.
Key words: medicine, drug, codeine, prescription, pharmacy.
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