Morality in pharmaceutical regulation

29 Jan
There’s been a lot of questions recently about NICE’s approval procedures for new drugs. My own familiarity with the process is only related to the ethics committees’ role, so I wouldn’t try to offer any kind of solution- let’s face it theres going to be enough of those thrown out half-cocked in the coming months. What I do want to talk about, though, is the morals which underly the process, or at least that should. Normally, I’d rail against the idea that societal morality makes sense, but here, it really serves a purpose.
 

Moral criticisms often get thrown at big pharma, for reasons I don’t really need to go through here. The same can be said for the regulatory procedures governing what drugs make it to market, and who gets them. Things aren’t necessarily so simple as is often made out, though- it just doesn’t come down to blindly following rules and disregarding compassion, as so many commenters blithely shout. So, what I’m gonna do is attempt to demonstrate that while both policy and morality are essential for regulating pharmaceuticals, the latter is determinative of the fundamental nature of regulation; and that without morals it would be impossible to interpret standards set to maintain successful governance of the industry. Big talk, for sure.

To frame the discussion we must first determine, in context, to what it refers and the assumptions inherent within it. As such my starting point will be to outline the general purpose and aims of pharmaceutical regulation, and to examine what may be considered to constitute effectiveness in the field. Of equal importance will be to define both morals and policy as regards the statement, including how and by whom they are formed- wherein I’ll consider the role of Regulatory Impact Assessments- and their interrelationship. This latter connection is key; and I’ll go on to examine how it affects the efficacy of regulation by evaluating the need for, and methodology of, Research Ethics Committees.

So, it’s of value to understand the terms used in the statement of position that we are investigating. You might define the act of regulation, in any field, as being to “control or supervise by means of rules and… directive[s] made and maintained by an authority”, and consider that the purpose of these controls is to maintain standards of conduct reflecting the goals of and generally accepted behaviours within an industry, market, or area of society. The authority by whom the constraints themselves are imposed and enforced might encompass a variety of groups, from governmental legislators to trade associations and social peers; and in the case of the pharmaceutical industry the former pair are particularly relevant. The aims which give rise to the need for regulatory instruments in industry are manifold, but as regards the pharmaceutical sector we might hold that the maintenance of a competitive marketplace and the desire to ensure quality and safety of product are paramount. Without regulated competition, there is a risk of encroaching dominance by the larger pharmaceutical research and manufacture conglomerates; and because pharmaceuticals carry inherent risks, product safety regulations are necessary to prevent potential harm to consumers and engender faith in the industry. On the latter point we might consider that pharmaceuticals are expressly “compound[s] manufactured for use as medicinal drugs”, and if there was no form of oversight and stricture ensuring that the products did no harm, they would be failing in their sole cause.

I SEE WHAT YOU DID THERE

If we take these aims to be achievable by degree, then, I have to ask  what might render an implementation as being effective. If we take effectiveness to be “[the production of] a desired or intended result” then it follows that an effective regulation is one which would move the industry closer to its goals. Though this idea may seem self-evident, it is the case that a regulation could be more effective than another while still falling short of the apotheosis. The desire to protect the health and safety of the consumer is illustrative of this ideal in the industry under discussion- while every length is taken in creating safeguards and methods by which dangerous side-effects might be mitigated, the fact remains that 7.75% of accidental drug-related deaths in the UK in 2009 were caused by prescription medicines. As a hypothetical, if this figure was emblematic of a reduced rate of deaths than a previous year with different controls, we would be justified in saying the new regulation behind it as being of increased efficacy.

With this established, it is necessary to examine how both morality and policy can be judged to affect this goal of successful regulation. By suggesting that one of the two is of dominant significance in effective pharmaceutical regulation, the statement under investigation implies that both policy and morality are necessarily both active constituents. For one factor to be objectively judged as being of greater worth in furthering the goals of the industry, both must have a figuratively measurable input into the system. This assumption is of value to our discussion as it links the two elements together, but also because it suggests that it is possible to distinguish between them. Consequently, it is important that we determine contextually what these concepts might consist of, and what bearing they may have upon each other in the process by which they give rise to industrial supervision.

In itself, a policy might be defined as “a course or principle of action adopted or proposed by an organization or individual” with the goal of guiding decisions to achieve the outcomes desired by the policymakers. Policies are necessarily the basis of regulatory instruments, which might be considered to be implementations of the solutions identified during policy analysis, a subject to which I will return. Obviously, all models of policy cycle include a stage wherein they are put into effect- policies are unable to achieve their goals unless there is an instrument, in our case of regulation, to enact them. It is important, however, that we understand  how policies inform the instruments of regulation, in order that we might determine why they might be more or less important than other factors.

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You probably wouldn’t need a committee for this.

These instruments arise in part through the application of Regulatory Impact Assessments, herein RIAs. Policymaking requires legitimacy, transparency, and reasonability, and RIAs are one way in which this can be both examined and displayed. Although the actual use of these assessments has been criticised on the basis that “the dependence upon individuals’ knowledge and expertise, as well as the absence of relevant data undermine the rationality of the Impact Assessment system”, they continue to be used in the formation of EU legislation, and are notable in the area of pharmaceuticals for having been used to produce such instruments as Regulation 1394/2007 on advanced therapy medicinal products. Think of them as being a method by which policy informs and is incorporated into regulatory instruments- their purpose is to scrutinise the potential impacts of a policy if it was enacted, and to determine the risk of those which it would be impossible to foretell without the depth of analysis and industry consultation that an RIA can provide. Where impacts could be problematic, solutions are sought, and in theory the final instrument will reflect these amendments. Ultimately, an RIA is intended as a means of verifying that a proposed regulation will bring a desirable benefit to cost ratio in achieving its objectives. This concern for societal welfare reflects the principle of beneficence found in medical ethics, and wider moral thought; which holds that the term “include[s] effectively all forms of action intended to benefit or promote the good of other persons.”

Just as elephants are known for their memory, Agent Bear was well regarded for his moral compass.

On this basis I’d suggest that RIAs are a moral agent, filtering policy to ensure it conforms to an acceptable actionable standard which can then be utilised by legislators. In order to understand this assertion and consider it in the context of the statement under examination, it is necessary to establish how else morality might relate to policy, and its greater relevance to the pharmaceutical sector.

While this  isn’t the place to debate the relativistic nature of morality, this having been the focus of a great number of works by those more learned than I can claim to be (my avatar is a comic book alien, what do you want?), it is of value for us to specify to what we refer by the term in our discussion. If we consider the two senses of morality, those found in normative and in descriptive ethics; we are faced with a choice between either a prescriptive, independent ‘right and wrong’, or in the latter a more subjective understanding reliant on individually and culturally accepted values. Given that we are focussing on a particular entity, id est the pharmaceutical industry- or more specifically those who legislate its regulation- descriptive morality looks like the most suitable understanding.  For our purposes, then, we will frame morality as being a value judgement, a subjective construct which describes a reason for taking a position. This latter notion is key, and we might hold that a ‘position’ is represented in the form of a policy. We might note the similarities which lie between this understanding and the definition of policy that we have outlined previously, in that both are a form of guidance and in theory a decision-making apparatus.

This notion, that morality gives rise to opinions which may be the basis of policy agendas, warrants further study, and in doing so we might question the process by which the former informs the latter. As I have noted, policies are principles intended to guide the industry into fulfilling goals which are deemed desirable, for instance the previously mentioned wish to protect the health and safety of the consumer. This example is nonspecific but it serves ably to demonstrate that the intent behind the creation of any such regulatory construct is necessarily of a moral basis.

In our illustration, the aspiration to ensure product safety is born of the innate belief that it would be morally correct to do so- that it would be immoral to produce drugs which are known to cause harm. This concept is exemplified if we consider that to do so would run contra to the previously mentioned principle of beneficence, which is the cornerstone of all ethical thought related to medicine. The primary corollary of the principle is non-maleficence, frequently termed as that axiom of the Hippocratic Oath primum non nocere, that first we should do no harm.

Ha!

If, for the purposes of this paper, we assume that our idealised pharmaceutical policymakers adhere to the moral beliefs generally accepted in society; we would then be safe in suggesting that they would rationalise their intentions by this principle also. Consequently, a policy or regulation which aimed to fulfil this socially designated moral aim must itself be moral. By extension, it is the morally constructed responsibility of government to act in the interests of its populace- therefore we might postulate that any motion to ensure their health and wellbeing, if we accept that as being in their interest, is a moral desire. This being the case, if we characterise “[p]harmaceutical products [as being] among the most efficient forms of therapeutic agents” and accept the implicit description of the pharmaceutical industry as being a provider of drugs intended for use as medicines, then we might be justified in the belief that the trade is ultimately inherently moral in its activities despite any lingering questions about the ethics of some practices. As I’ve mentioned, policies are pretty much just statements of intent- and therefore if they are designed to work towards a morally sound goal, be that of the industrial objective or the regulatory objective, it follows that they must themselves be of a moral nature.

Having attested to the relevance of morality in the context of pharmaceuticals, and having identified the idea that morality is the basis of policy, we are led to ask if this hypothesis could be construed to support the statement that ‘regulating pharmaceuticals effectively is more a matter of morals than of policy’. Our postulation would appear to suggest a dominant importance for morality, if the earlier assertion that regulation is a fundamentally morally-guided form of legislation is accepted. By virtue of being the originating point of the aims that a regulatory instrument might have, a moral holding could be seen as being of more influence than policy; which is itself a moral construct. In essence, the same moral position informs both the policy and the legislation that arises from it, the latter given shape through the former. However, the assumption we have previously outlined in the statement at hand is that both elements have their own input into the efficacy of  active regulation, despite any interrelationship in their formation. Accordingly, we would be remiss to reach a conclusion without an examination of this input, one form of which can be exemplified by Research Ethics Committees, herein RECs.

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Listen, ’till I can get a dramatic transformation like this, you can keep your research.

By its very nature, the biomedical research involved in developing therapies and products for the pharmaceutical industry is constantly “undergoing dramatic transformation”. New types of medicinal commodity are consistently under development, as exemplified by the wide advent of biologics. Derived from organic sources rather than being chemically synthesised, such treatments can include a “wide range of products such as vaccines, blood and blood components, allergenics, somatic cells, gene therapy, tissues, and recombinant therapeutic proteins.”

You’ll recognise contributing elements such as genetic technologies and stem cell research as being the centres of widespread ethical debate both within academia and in the wider public sphere, and so we can assume that they carry potential moral problems which develop alongside them. Given that these technologies will continue to develop and give rise to new products and issues, it is unrealistic to expect any given regulatory instrument to be able to enforce policy ideals in situations which may not have existed at the time of their institution. As an example, biologics as a generality are regulated by the  previously mentioned document on advanced therapy medicinal products, which builds upon the  2001 Directive regarding medicinal products for human use as this latter instrument did not cover the new technology. Ethical issues, too, are ever-changing and are often highly varied between individual products- for instance, where one gene therapy was relatively uncontroversial, utilising an equivalent which involved genetic material derived from an animal would carry a different set of issues. Regulation can include methods by which legislators attempt to ‘future-proof’ the document somewhat, and the institution of RECs can be thought of as an example of this. European Union Directive 2001/20/EC, also known as the Clinical Trials Directive, instituted RECs as a formalised element of the clinical trials process for medical products and devices, responsible for oversight of the moral aspects of testing any given product and the protection of the rights and welfare of the human subjects.

We might acknowledge then that RECs are in a position to address the vagaries of individual instances that could not be directly regulated by an instrument such as the Directive itself- they could be construed as a form of devolved regulation. Although bound by the overarching legislation, RECs can be thought of as having a comparatively subjective approach- whether an application to enter trials is approved or rejected is a matter of the opinion of the committee. If we consider our conception of the term ‘moral’, we can apply it to the work of the RECs- their work is necessarily of a moral nature, as it concerns the welfare of the subjects: an idea we have discussed elsewhere under the subject of beneficence. In coming to a conclusion regarding an application, each member of a committee is employing the process of moral judgement, which we can define as “the ability to reason correctly about what ‘ought’ [in their subjective opinion] to be done in a specific situation.”

Judge Dredd

What’s cool is that they get to dress like this while they do.

To once more utilise my example of the moral regulatory goal of ensuring product safety, we can see that a decision by an REC to deny a trial on the basis that it would be too risky for the participants, and therefore ethically unsound, is very similar. If we assume that a pharmaceutical regulatory policy aims to fulfil socially accepted moral standards, we can also assume that the members of the REC also operate under these same ideals and are attempting to apply them to the case in front of them. In other words, they are using morality as a method by which to apply regulatory policy in order to comply with the legislation.

While this exemplifies inputs by both elements of interest- policy as guidance to be applied and morality as the method- we might suggest that without the use of a moral agent in the form of the REC the former would be ineffectual, which lends an implication once more that of the two the latter is of greater value. If I was to elucidate on the concept that the committee members are utilising the same moral ideas that inform the goals of regulation and form the basis of policy, I’d suggest that for any policy to be actionable as legislation it is essential that there exists moral coherency throughout the industry and between it and the regulators, lest any interpretations differed. If alternate moralities were applied by an REC, the aims of the relevant policy would not be served.

As such, I’m going to conclude that while both policy and morality are essential for regulating pharmaceuticals, the latter is determinative of the fundamental nature of regulation; and that without morals it would be impossible to interpret standards set to maintain governance of the industry. So, in my eyes, morality is of greater importance than policy in the regulation of pharmaceuticals.

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