Masterarbeit
New drug substances with abuse potential: Points to consider for the development and marketing ***
Dr. Silke Jung (2006)
(Regulatory environment in the European Union and the United States)
Language: English
Many substances suitable to treat neurological and psychiatric disorders have stimulant, depressant or hallucinogenic effects on the higher functions of the central nervous system and thus may have an inherent tendency to promote abuse and dependence. In many cases special measures of control are necessary to prevent abuse and diversion of these products.
Control measures for psychoactive substances have been established at international level with the Single Convention on Narcotic Drugs 1961and the Convention on Psychotropic Substances 1971. The UN Conventions and any amendment thereof are not self-executing: To be able to enforce them the Parties to the Conventions, to which most countries belong worldwide, have to transpose them into their national legislative systems. The need for national adoption of the UN Conventions has led to a considerable variability in national classification and control systems. Most of the classification systems rely almost exclusively on an individual list system, i.e. they list (schedule) chemically defined substances or preparations thereof. As a consequence, only substances explicitly mentioned in one of the national schedules are controlled. Any derivative (except for some salts, esters, ethers etc.) being chemically distinct from the listed compound is outside the scope of the legislation and thus per se not controlled. Individual list systems do have the advantage that there is no doubt about substances falling within their scope, but they often have the disadvantage of being rather static and slow as far as updates are concerned.
When pharmaceutical companies develop new psychoactive substances, they must bear in mind that these substances may require control. To be able to assess the abuse liability of new psychoactive drugs, additional studies (animal and/or human) are necessary and may be required by regulatory agencies. The procedures for putting a new substance under control (scheduling actions) are generally separate from the actual marketing authorisation procedures. Therefore, pharmaceutical companies need to have an intimate knowledge of the national classification systems and the legal provisions regulating national scheduling actions. It is also important for them to know that global registration strategies must be supplemented by scheduling strategies to ensure that scheduling decisions are taken in a timely manner and do not delay or prevent marketing of the products. Pharmaceutical companies must bear in mind that their global registration strategy might be influenced by the need for scheduling actions.
From a marketing perspective, it is furthermore important to understand that the scheduling of drugs may have an impact on their availability and patient access, and thus ultimately on revenues that may be expected.
This master thesis analyses the additional data requirements for psychoactive substances, the classification and control systems, as well as scheduling actions and their relation to marketing authorisation procedures in the U.S. and five European Member States. The situation in the U.S. was found to be very transparent whereas, it seems more complex in the European Union. This may be due to the fact that the EU is a conglomerate of 25 Member States and that the legislation on controlled substances is governed almost exclusively by national law whereas marketing authorisation procedures may be run at a supra-national level. This thesis has revealed a clear need for a harmonisation of classification and control systems in the European Union.
Considering its territorial restriction, the current master thesis can naturally only be a starting point for a broader analysis of all aspects to be considered when new abuse-liable drugs are developed.
Pages: 74, Annexes 16