VISON, GOALS, NEEDS, STRATEGY TIMELINE, OBSTACLES
STRATEGIC PLAN 2023-2024
VISION:
European Kratom Alliance, believes strongly in principles of harm reduction, human rights and social justice. Our goal is a complete legalization of Kratom in the EEA and entire continental Europe. We aim to so by creating a functional market, where Kratom can be legally purchased and consumed responsibly by any adult person on this continent.
GOALS:
- Complete legalization of Kratom in Europe ( via novel food procedure or different means)
- Creation of legal and controlled market for Kratom
- GMP for Kratom
- Legalization of Kratom in at least two countries by the end of 2024
- Consolidation and bringing out Kratom vendors out of gray zone
STRATEGY:
We will focus on organized advocacy and lobbying efforts of the European and national regulatory bodies. We will highlight benefits of use of kratom and its history. At the same time we will aim to build a coalition of like-minded organizations with which can collaborate.
At the same time, we will try to create a loose network of self-sustaining kratom advocates. ( Starting with Norway and Germany).
We will focus on organized advocacy and lobbying efforts of the European and national regulatory
bodies. We will highlight benefits of use of kratom and its history. At the same time we will aim to
build a coalition of like-minded organizations with which can collaborate.
At the same time, we will try to create a loose network of self-sustaining kratom advocates. ( Starting
with Czech Republic, Slovakia, Germany, Netherlands and Austria).
To gain more recognition in the eyes of the regulatory bodies and academic world, we will establish a
scientific advisory council.
LEGALIZATION:
According to the pathway set by the regulators, currently there are two possible pathways to legalize
kratom in Europe.
NOVEL FOOD:
First approach is set by the Novel Food Directive. Novel Food is defined as food that had not been
consumed to a significant degree by humans in the EU before 15 May 1997, when the first Regulation
on novel food came into force.
‘Novel Food’ can be newly developed, innovative food, food produced using new technologies and
production processes, as well as food which is or has been traditionally eaten outside of the EU.
According to this definition, kratom classifies as food that has been traditionally eaten outside of the
EU. The procedure defines that an entity, which wants to place product on the market, needs to
submit request to the European Commission. The request is examined by the European Food Safety
Authority, European Medicine Agency, European Centre for Monitoring Drugs and Addiction, and the
Member States. The process would be guided by EFSA, and would last either 4 or 8 months. During
this process EFSA assess safety of the product to be placed on the market. EKA cannot be the entity
that places Kratom on the market, but due to our lobby status in the European Union, we can prepare
groundwork for this procedure and influence the decision making process.
The estimated cost of applying for the novel food would be around 300 -500 thousand euros. It would
require as well hiring a consultancy company, that is specialized in the Novel Food procedure. The
basis for the procedure should be socio-economic data and studies, from South East Asia, that date
AT LEAST 30 years prior to year 1997. EFSA’s stance towards Kratom is similar to FDA, therefore the
application should be supported by clinical studies conducted by our international partners. #
PROS:
– Less labour intensive and focuses only on the European Union agencies
– More cost-effective
– Simple legislative path
CONS:
– Lack of needed studies
– Problems with transparency rules
– Negative attitude from certain member states and European Union Agencies ( primarily EFSA)
– Lack of necessary contacts, structures and procedures on our side. And lack of manpower
COUNTRY TO COUNTRY APPROACH:
This approach is more time consuming, but definitively it is more preferable at this point in time of
existence of EKA. As we are lacking in manpower, experience and we don’t have established
relationships with legislator. This approach allows us for building up a reputation between different
member states, and at the same time it buys us time to develop our own procedures and strengths,
when approaching different legislators.
Psychomodulary substances act, which would regulate the sales of drugs inside the Czech Republic
can be introduced only in certain European Countries, in which approach to drugs is fairly liberal (
Portugal, Spain, Netherlands, Croatia, Slovenia). In other countries, we can only decriminalize kratom
and get it out of the prohibited substances list, which would open those countries markets for
potential sales.
Directorate General Home Affairs of European Commission developed a following approach to
Kratom:
Kratom is monitored as a new psychoactive substance by the EU Early Warning System under
Regulation (EC) No 1920/2006 as amended by Regulation (EU) 2017/21011 . This system is operated
by the European Monitoring Centre for Drugs and Drug Addiction (EMCDDA) in close cooperation
with European Union Agency for Law Enforcement Cooperation (Europol). Kratom is not controlled at
Union level, meaning that it is not included in the definition of ‘drug’ in Council Framework Decision
2004/757/JHA2 . The Commission is not planning to propose any changes in this regard. The trend of
increased popularity of kratom among minors has not been reported to the EU Early Warning System,
and the Commission does not have further information pointing to such developments. According to
EU law , Member States may maintain or introduce in their territories, with regard to new
psychoactive substances, any national control measures that they consider appropriate
PROS:
– More flexible approach based on needs of different countries. Sometimes we can introduce a
full legalisation sometimes we can just manage decriminalization.
– Allows for building up our capacities and procedures
– Allows for legalization of kratom outside of the EU
– Builds up our network of different stakeholders
CONS:
– Longer path, sometimes possibly a hostile attitude of media, and legislators inside the
country.
– Some countries do not have defined rules of engagement on lobbying
– Costly in a long term
– Delays legalization of kratom in Europe
EKA to achieve the goals above needs maintain a wide network of different stakeholders:
– Scientists
– Likeminded NGOs
– Policymakers
– Lawmakers
– Universities etc.
NEEDS
This section covers needs of EKA to ensure its ability to function as lobby in the European Union. I
believe that for this we have to build a small team of people who can support our current and future
needs.