Tag Archives: market access

Smart anti-counterfeiting: it is all in the system’s design

How can I be sure the medicine I take is genuine?

Counterfeit medicines are a global problem, with trade in the billions of dollars. The World Health Organization estimates 8-10% of all drugs supplied globally are counterfeit.
Counterfeits are a clear and present danger to human health. No country is immune from the risk. Fake medicines are hazardous, with documented toxicity, instability and ineffectiveness but few people are experts in pill authentication (even pharmacists get fooled). Counterfeit drugs are easier to make and fake than money. But there is little patients can do but rely on assurances by others that drugs are genuine. That may not be good enough.

The health and medicines regulators had for years believed there wasn’t a problem because there are few cases from their perspective. But today we know better and there have been efforts to address regulatory denial.

Counterfeit medicines are infiltrated into the supply and distribution of legitimate medicines by rogue, criminal organizations and individuals, who specifically target the weaknesses in supply chains, as well as human weakness (bribes and kickbacks) and gaps in healthcare payment systems.

Counterfeiting had originally been viewed as a patent issue legal advisors took a purely legalistic interpretation. It was not until the problem of counterfeiting was presented as a risk to human health and people’s lives that the dead end logic of patent protection was dropped. But why did the lawyers fail understand the context in which the problem existed? New legislation is always being introduced, such as the EU’s Falsified Medicines Directive, but the criminals will find a way to game this, even though this directive was apparently ‘gamed’ by developers using the French problem with the drug Mediator. However, gaming policy for developmental purposes also needs people to think like a criminal.

Once a medicine has been factory sealed by the pharmaceutical manufacturer, there is no assurance that it will reach the patient unopened; a pharmacist and doctor can open it, and packages that cross borders are opened for repackaging and labelling. Indeed, there are companies with the licensed authority to repackage factory-sealed medicines with new labels in new languages. Unscrupulous distributors can conceal the illegal substitution of counterfeits within these apparently highly regulated systems. Many countries are net importers of medicines as they lack sufficient domestic manufacturing capacity or the medicine is complex and is manufactured in only a few places. This makes these countries vulnerable to supply chain interference.
While international trade in medicines trade has often focused on internet pharmacies, the real problem is that the online mail-order environment is a counterfeit drug delivery system into every home on the planet.

Healthcare systems themselves must address perverse incentives that drive criminal behaviour; keep in mind that criminals exploit weaknesses in supply chains, laws and regulations, and respond to unmet demand for a product (from toasters to cars, there are illegal markets everywhere and not just for drugs) resting on common incentives. A major driver for criminals is the existence of cash markets for their products (they tend not to take cheques), and one of the largest cash markets is people without adequate health insurance cover and reimbursement systems that do not cover the full cost of medicines, or fail to insulate patients from high drug costs. In addition, as information on medicines can now be widely salient through internet social media, a country failing to license a medicine that some people would value opens a door to counterfeiters to exploit a patient demand for that medicine.

What Cognology says.

Catching crooks with counterfeit drugs is also a problem of finding them. Using advanced intelligent technologies (cognologies as in the name of this blog) means that surveillance can be smarter and less distracted by false signals.

“I told you so”: post-Brexit access to medicines and medical device technologies

Continuing the theme of looking at life sciences, healthcare implications for the UK exiting the EU.

  1. The NHS, the UK’s public healthcare system, procures medicines in many cases through the benefits of the single market. While it is not clear what impact an exit will have on pricing itself, failure to ensure access to that single market will inevitably lead to the increase in drug costs. I’d hazard a guess of 10%. Given the difficult financing circumstances of healthcare expenditure in the UK, an increase of this magnitude, will have a knock-on effect on patients and their care.
  2. Apart from the price impact, UK patients may find access to medicines and medical devices restricted as the UK exits the wider European market overseen by the European Medicines Agency. The UK is not every companies’ first choice of a market to launch a new medicine or device, but with an exit, it clearly will drop further down the queue. Excluded from products launched in the rest of the EU, the UK can only wait for companies to ‘get around’ to including the UK.
  3. And apart from the loss of a degree of certainty of access to medicines and devices within the EU, a UK exit, the UK will need to introduce a separate regulatory scheme to replace the European Medicines Agency approach, adding costs and an additional regulatory hurdle for companies. The UK can, of course, try to harmonise itself with EMA, but in the end, departing EMA will reduce patient access to medicines.
  4. Is the UK market big enough to make a difference? Perhaps for some, but I suspect the economics coupled with the overall difficulty new products face contesting the UK market points to a general decline in product availability. At least with the EU, access to medicines and devices could be compared to other EU states; with an exit, the UK stands alone and does not look particularly welcoming.
  5. Of course, the NHS could have a rethink as is slowly underway and move to ensure access to new medicines and technologies. But that may require a different assessment whether the current way of financing the NHS itself is sustainable and that has really little to do with leaving the EU, although the EU does offer a safety value for patients denied care by the NHS. All this is now in jeopardy.
  6. The European Medicines Agency will need to leave the UK, and with it will go not just those jobs, but a whole domain of expertise. That expertise with EMA made the UK within the EU, one of two global centres of excellence in medicines regulation, along with the US FDA, Few people outside this area will appreciate the consequences of EMA departing, but it will be felt within pharmaceutical who maintain many high-paid and knowledgeable staff focused on medicines regulation. All this expertise goes and with it a capability within the UK that can never be regained. Whoever gets the agency, Sweden, Denmark, elsewhere, will be a net gainer of  talent from which to build tremendous domestic capabilities.

What Cognology says

Perhaps, I told you so?

Broken logic: NICE and the Cancer Drug Fund

Sir Andrew Dillon, the erstwhile leader of NICE as said that it is irrational for the Cancer Drug Fund to pay for drugs that NICE has turned down.

He’s right of course, it is irrational. But only if NICE’s logic is compelling.

The problem for Sir Andrew, and like-minded people, is that there is another logic that trumps NICE’s rational world. Don’t get me wrong. NICE performs a useful, but technocratic, function with analytical assessments that any rational person would indeed want to know. Where we part company is believing that NICE’s logic is the final word on the matter. Which it isn’t.

Tasked, perhaps unenviably, with parsing the performance of medicines and clinical practice, cannot also mean that they are above challenge. Many of NICE’s rulings fly in the face, not of logic, but of our beliefs as humans. It is why we do things when the odds are against us, because not to do so would be wrong. If we think of the challenges NICE faces as wicked problems, that is complex problems with a multiplicity of solutions, it becomes self-evident that their logic is just one way of deciding and choosing. We could use other rules, other criteria. The Cancer Drug Fund is just such an approach. It is another matter whether we should have in place alternative funding approaches that individuals can avail themselves of (such as co-payments or co-insurance); for extraordinarily costly therapies, co-funding would not apply, so we’ll back to the problem anyway.

NICE has a troublesome relationship with the notion of ‘rule of rescue’ and so has decided to ignore it. There replacement, the “end-of-life premium” is really just a reweighting of the logic they use.

You see, the rule of rescue is what we might call a meta-rule — it is a rule that tells us if other rules are working properly, and importantly, as a moral imperative which tells us what to do. The rule is often invoked in a particular form: that people facing death should be treated regardless of cost. The rule as originally formulated is really about assisting identifiable individuals facing avoidable death (Jonson, 1986); the bioethicists and economists have shifted this to a cost-effectiveness approach, making it one about trade-offs instead.

The problem for healthcare systems is that all patients are becoming identifiable as medicines become personalised (medicines may become orphan drugs). The problem for the NHS is that it does not allow such people to rescue themselves because it prohibits any sort of co-funding or other arrangements. The only option is an opt-out (and private medical insurance has rules about pre-existing conditions). Given the funding priorities of the NHS, we should be reflecting not so much on how to make the pot bigger, but on using the money that is available better (there will never be enough money), and ways to introduce practical co-funding.

Since individuals have no other options in the NHS, the rule of rescue as a moral imperative will be violated and we will act, not out of analytical error (i.e. make a technical mistake), but unethically. You see, the NHS must be the healthcare system of last resort and therefore of rescue, otherwise, identified individuals are destined to a death sanctioned by public policy and is that a policy or healthcare system worth having?

We have seen a similar challenge to NHS/NICE logic recently with the King family and proton beam therapy, and the NHS will also use NICE logic to determine access. Whether beams or drugs, it is the same argument.

But why cancer? The main public policy question is why should cancer patients be given preferential treatment as against any other deserving group? This may in part be driven by the often astronomical costs of new cancer therapies themselves, which demarcate cancer patients decisively from equally deserving patients with less cost-contentious therapies. I have just finished some work on motor neuron disease, for which there is one specific medicine and life expectancy from diagnosis is 3 to 5 years, with median survival rates that are measured in months. NICE reportedly is developing guidelines for this disease. Costs are considerable, and at least in the UK, highlight the bureaucratic illogic of separate healthcare and social care, but that is another story.

What Cognology says

The moral dilemma that the economists at NICE are trying to reduce to an equation is whether a new therapy is extending life, or delaying death. The Oregon approach collapsed when the hard choices emerged and people were unable to resolve this dilemma, which is not a quantitative issue, but one of how we value our humanity. Kierkegaard’s Concluding Unscientific Postscript speaks of the leap to faith as involving self-reflection and the emergence of scepticism. It is worrisome that NICE is so confident.

Further reading

Cookson R, McCabe C, Tsuchiya A. Public healthcare resource allocation and the Rule of Rescue. J Med Ethics. 2008 Jan 7 [cited 2014 Sep 4];34(7):540–4.

Jonsen, AR 1986, Bentham in a box: technology assessment and health care allocation, Law, Medicine and Health Care, Vol 14, pp172–4.
Richardson J, McKie J. The rule of rescue, working paper 112, Centre for Health Program Evaluation, Monash University