CSCS Expert Community:
The Changing Landscapeof Drug Controls
Introduction
Key Information
Project Lead Andreas Schumacher
Project Manager Claire Bellamy
Goal of the Expert Community
To improve the understanding andinterpretation of controlled substancelegislation around the world.

Drug controls are a key compliance issue for companies that handle
large numbers of research compounds. Legislation has become
more complex and changes are being made more frequently. The
Controlled Substance Compliance Expert Community brings
together specialists from across the industry to discuss areas ofuncertainty and enhance best practice.

How things havechangedIn the beginning…
International agreements to control drugs were put in place in the1960s
1961

Single Convention on NarcoticDrugs‘Yellow
List’e.g. Heroin

1971

Convention on Psychotropic
Substances of 1971

‘GreenList’e.g. MDMA

1988

United Nations Convention against
Illicit Traffic in Narcotic Drugs andPsychotropic Substances

‘Red
List’

e.g. Acetic
Anhydride

These lists were based on named compounds and their salts,
stereoisomers, esters and ethers.

1970s - Response to chemical modification
Synthetic compounds start being developed such as MDMA.

In response, a new class of generics appear in legislation. A core is
specified that can be substituted in multiple places.

Belgium, Germany, Poland, UK and the US haveenacted laws containing super-generics in the past 2years. Some include research exemptions, but someof this legislation makes compliance more complex.
The UK, for example, brought in such a broad
definition of synthetic cannabinoids in 2016, that it
encompassed a significant percentage of a typicalpharma compound bank. It also affected establishedmarketed medicines and in-flight clinical trials.
After consultation with the CSCS Expert Communityand others, the law was amended in 2019 to reduce
the numbers of non-psychoactive compounds
affected and focus controls on the intended target.

Expert Community
The increasing complexity and scope of controlled
substance legislation mean it is vital to understandwhen legislation is about to change and assess theimpact on your organization. The penalties forincorrect compliance are significant: ranging fromlarge fines to loss of reputation and potentially lossof license to operate.
The expert community provides a forum to discuss
best practices with your peers so you can build yourunderstanding, plan and put into practice thenecessary changes to your internal processes ingood time.
The community runs a range of activities anddiscussions, and members can bring questions to thegroup. External speakers are invited to present on
topics of interest and in-depth work is undertaken by
sub-teams when required.

Compliance is no longer a matter of checking against a list but
requires a sophisticated structural check.

2010 onwards - Explosion of illegal synthesis
Shops appear that sell ‘legal highs’, synthetic drugs are specificallydesigned to avoid the law. Countries start to legislate in a much
more generic way, with bans based on biological effect or structuresthat are made of multiple component parts.

Conclusion
The legislative landscape has changed beyond
recognition and controlled substance legislation ismore complex and rapidly changing than everbefore. The CSCS Expert Community brings together
experts in a network that aims to improve practiceand works together to bring clarity to areas ofuncertainty.

References
www.CSCS-Experts.org
Taylor, Daniel, et al. (2015), "The Pistoia
alliance controlled substance complianceservice project: From start to finish." Drug
Discovery Today, Volume 20, Issue 2, pp 175180.

Pistoia Alliance: Lowering barriers to R&D innovation
The Pistoia Alliance is a global, not-forprofit alliance of life science
companies, vendors, publishers, andacademic groups that work together tolower barriers to innovation in R&D.

Our members collaborate as equals on
open projects that generate significant
value for the worldwide life sciences
community.

www.pistoiaalliance.org@pistoiaalliance