Insurance: The Missing Link in the Harm- Reductionist Approach to New Psychoactive Substances [NPSs]
Updated: Oct 19, 2019
The report on New Psychoactive Substances, published by the All-Party Parliamentary Group for Drug Policy Reform [APPGDPR, 2013] suggested (amongst other things): “That the government consider adopting the key features of the New Zealand policy” and “that the onus should be on potential suppliers to demonstrate that a psychoactive substance has an agreed ‘low risk of harm’”. A joint Demos/UK Drug Policy Commission report reached a similar conclusion, endorsing the development of a new system – outside the Misuse of Drugs Act – of temporarily controlling or regulating new drugs so that their actual and potential harms can be assessed, and determining the feasibility of fitting a suitable control framework under existing consumer protection legislation (Demos/UKPDC 2011).
Over recent decades the pharmaceutical industry has established and refined a methodology for assessing new compounds and medicines – otherwise known as clinical trials. Phase I is the first stage of the clinical trial, which investigates safety. It is performed on healthy subjects, and monitors any adverse effects to the volunteers as a result of the treatment.
Were all NPS-vendors in the UK to immediately conduct safety trials for their products, the current situation would improve in ways which we will detail shortly – but there would still be a serious shortcoming to even this improved model, and we will below suggest a framework that could help to solve it.
In order to minimise harms, the best situation would be if vendors of NPS refrain from selling any products until they have undergone safety trials.
Improvements brought about by selling only safety-tested NPSs would include:
Richness of information – The medical community’s problem with treating users of unknown NPSs is that they are exactly that – unknown. Even in the very rare cases in which only a single compound is used and the patient knows exactly what the substance is (as in cases in which the patient saves the product wrapper), there is no clinical information available to the medical caregivers. In the absence of any clinical information about the substance, doctors are risking exacerbating the patient’s condition with inappropriate treatment. In order to avoid this risk, they normally simply monitor the patient’s condition and apply treatment for symptomatic relief. Safety trials could change this state of affairs dramatically with pre-clinical toxicology testing of animals that must be performed before human trials can be approved. Pre-clinical toxiclogy trials produce a rich foundation of clinical information, that empowers doctors to make informed decisions and thus to give proper care.
Initial assurance of safety – Often, in these pre-clinical toxicology trials the animals are administered doses that are 10 times the recommended dose for a human (corrected for body weight). After the trial, the animals are sacrificed, and their tissues examined closely for any damage that could have been induced by the NPS being investigated. Naturally, any substance that was shown to damage certain organs or systems in animal trials would not be allowed to progress to human trials. This trial seeks to ensure that human users of the substance will not be harmed, even if they exceed the recommended dosage. The UK Government lacks the means to test all the new NPSs that become available through the internet. (In 2009, 24 NPSs were notified for the first time in the EU; in 2012 the number was 73 [EMCCDA/Europol, 2013].) It is therefore necessary to place the responsibility for safety-testing into the hands of the producers or vendors – if the NPS passes the safety test, the producer/vendor would be rewarded by the substance being considered legal for regulated sale.
Reduced rate of appearance of new NPSs – Tested and regulated NPSs will, if such a regime is introduced, appear on the market much more slowly, as the process of testing is very expensive. In the scenario described above, vendors will test the safety of the products prior to bringing them to market. Since not all substances will pass the test successfully, the rate at which NPSs appear on the regulated market will diminish.
Despite the many problems alleviated by this evidence-based approach, there would still remain a serious shortcoming. The idea of safety-testing NPSs prior to bringing them to market has been suggested before (Gee and Fountain, 2007; Winstock and Ramsey, 2010; Fisher, 2012), and even hailed as “unique progress” by the All-Party Parliamentary Group for Drug Policy Reform [APPG, 2013] when referring to New Zealand’s emerging legislation. However, this same report also pointed out that the experimental policy conducted by New Zealand on Benzylpiperazine (BZP) between 2005 and 2008 failed, partly due to “a lack of enforcement of those regulations restricting its supply”. This is an important point, because clearly the demand for available NPSs may be so great that if such a material were to be declared “safe” (within certain usage limits) it could register in the public mind as safe at any dosage – and a public binge could ensue. Therefore an inherent braking-mechanism needs to be incorporated into the system, if the failure of the BZP-experiment in New Zealand is not to be repeated with the regulation of NPSs in the future.
Thus we propose a method of regulation for NPSs based on two principles:
1. Testing NPSs for safety according to pharmaceutical standards.
2. Insuring the consumer of the NPS for each usage.
Two different entities would be involved in the process of supplying the consumer: (1) commercial companies selling safety-tested and insured NPSs; and (2) not-for-profit insurance bodies insuring the consumer against any mishap resulting from the sale and use of the drug. The not-for-profit insurer would direct any surplus funds received from their operations to a scientific charitable organization which would fund and direct scientific research, and produce educational material.
To regulate correctly an NPS that has been found to be safe, we suggest the founding of a not-for-profit insurance body that insures the consumer in exchange for a fee (a small portion of the cost of the NPS). A commercial insurance body would naturally have as its mandate the maximization of profit, which would be achieved by selling more insurance – and therefore more of the NPS. That is why it is key that this insurance body should be a not-for-profit.
This insurance body and the insurance policies it sells would play many roles in making this system work:
The insurance body would funnel its surplus funds towards a charitable organization which would be in charge of research and education. The first research objective would be to establish a clinical practice manual for all NPSs, so as to inform the medical community of the full information known about these substances. The second research objective would be to develop an antidote to each NPS that would rapidly cancel its effect. Such an antidote, if purchased with the NPS, could be both useful in the (rare) case of an adverse reaction, and comforting for the consumer to know that he or she has an “escape” button available. Lastly, the insurance body’s mandate would create educational material for users, so as to teach them the safe dosage and to prepare them for their first encounters with NPSs. It would also encourage them to delay first use to an appropriate age and, if they do use, to do so in a responsible manner.
The NPS-consumer would be covered for any medical and related costs incurred as a result of taking the NPS, so long as the dosage guidelines specified in the policy had been followed. The medical community is constantly at a disadvantage when treating NPS-related complaints, because there is no clinical information as to how to treat them. Despite this, medical staff are responsible, by law and their oath, to safeguard the public’s health. The extra treatments, advice or literature required to treat the consumer appropriately would be supplied by, and funded by, the insurance body.
The consumer of a regulated NPS would have the assurance that the NPS had been tested for safety; and, through the insurance policy, would have the additional assurance that if something untoward did result, he or she would be financially covered. This would also relieve the state of much of the burden of costs arising from problematic NPS-use.
That additional assurance is precisely what is lost to the consumer if he or she breaches the guide-lines set forth in the policy – for example with respect to dosage or frequency of consumption. This should motivate the consumer to moderate consumption in accordance with the policy.
The insurance body would continue to refine its knowledge of the reaction of different kinds of people to different NPSs, and could in principle make personalized policies. The price of each policy would reflect the risk that a person runs in consuming the NPS.
The insurance body would relieve the government of the burden of managing this complex problem, and would fund the research that improves management from the premiums it collects.
The state would insist on the insurance policy being included in any regulated sale. This would then be somewhat similar to driving. When we drive illegally, we void the terms of our insurance and, on the other hand, it is illegal to drive without insurance. The double advantage to the consumer of the system here proposed is that he or she would be getting a substance with a defined ingredient and strength (as opposed to an unknown powder), and would additionally be insured against any accident.
In this way, NPSs that have been safety-tested and use-insured will gradually enter the regulated market, thereby reducing potential harms and costs.
All-Party Parliamentary Group for Drug Policy Reform (2013). Towards a Safer Drug Policy: Challenges and Opportunities arising from ‘legal highs’.
Demos/UK Drug Policy Commission (2011). Report on legal highs, Taking Drugs Seriously, p. 99.
EMCCDA/Europol (2013) EU Drug Markets Report: A strategic analysis, p. 106.
Fisher, D. (2012, 28 July). “’Revolutionary’ legal high law means state regulated drug market” The New Zealand Herald.
Gee, P. and Fountain, J. (2007). Party on? BZP party pills in New Zealand. Journal of the New Zealand Medical Association, vol. 120.
Winstock, A.R. and Ramsey, J.D. (2010). “Legal highs and the challenges for policy makers,” Addiction, 105(10):1685–87.