Tag Archives: pharmaceutical

Regulating internet pharmacies at the European level is necessary

Various prescription and street drugs may caus...

Available over the internet

It would be a serious mistake not have an EU-wide regulatory framework for internet pharmacies.  Not achieving one would be just more evidence of the politics that infects all discussions of cross-border healthcare to the detriment of the patient and health consumer.  Illegal drugs, fake drugs, reimported drugs, counterfeit drugs, substandard drugs, legitimate drugs — how is a consumer to tell the difference on the internet?

We need an EU-wide regulatory framework for a few pretty sensible reasons:

  • EU wide standards would ensure a common standard of practice, and European citizens should expect no less.
  • A key element of internet pharmacies is their cross-border character, and indeed whether they are inside or outside of the EU itself; the provenance of a medicine is integral to knowledge about its legitimacy and by breaking the information flow about specific medicines in a cross-border environment, the EU is putting people’s lives at unnecessary risk.
  • Price differentials within the EU actually encourage internet pharmacy sales, as it is these price differentials that make internet medicines attractive to consumers, and which create the risk of buying counterfeits in the first place. It is also known that the cash market in medicines underlies the opportunities for criminal elements to insert fakes into the medicines supply chain.  This will only become easier to do and harder to detect.
  • Cross-border trade in medicines involves a lot of repackaging, relabeling, etc., which destroys or confuses such information as batch numbers and point of origin.  This is essential core EU-wide information.

Leaving all this to different national regulators will simply play to the regulatory patch-work that characterises medicines regulation in the EU, and ensure that consumers will be confronted with varying degrees of protection, information and risk.

Despite protections from other EU directives on cross-border sales, medicines and the risk of counterfeits put the issue into a different situation as the efficacy of the medicines may only be determined after the patient has experienced the consequences to their health from the purchase of a fake medicine.

Member states are not that good at organising multi-lateral arrangements, so why should we expect them to be any better on medicines trade in a cross-border world?  The complexity of the EU will now be sustenance to those who would wish to contaminate the medicines supply chain.

I am obviously trying to decouple the problem from the issue of parallel trade, and focus on the core elements of cross-border regulation.  Parallel trade would be caught by a simple internet regulatory framework.

What would a solution look like?

Well, the opportunity to establish an EU Internet Pharmacy Imprimatur will be lost, as it would have been a key element in the solution.  It would have established basic information about the legal status of the internet provider, and its legal dispensing practices, including handling of prescriptions.  It would have given us pooled knowledge about all medicines, whether legal or not, with their origins and destinations being available in an EU-wide systematic manner.  With common regulation would come shared knowledge of all regulated and licensed firms operating in the very complex medicines supply chain; this information is not shared across borders, with obvious consequences.

The push-back from industry on the technological side is understandable but to be regretted.  it is possible to establish common technologies, and common data-gathering to make a sensible system work where costs are not onerous and patient safety is assured.  The outcome to be achieved is common knowledge across the whole medicines supply chain in a cross-border world. In addition to the much-talked about radio frequency tags, and barcodes, there are other methods available or in development which offer additional opportunities and are likely to alter the impact of costs on industry.  The current technologies are hardly longer term solutions anyway, but industry will need reasons to explore them.

A common regulatory framework for cross-border medicines trade over the internet is sensible, and does not really need the problem of counterfeits to be justified.  Industry resistance needs to understand that consumers, who will be in the main buying these medicines, need assurances of appropriate dispensing, quality of the medicines, proper shipping, and expiry dates,for example.  They also need to have named individuals if there are concerns, as mistakes can happen such as the wrong dosage being provided.  As well, there are naming differences amongst member states of similar medicines, dosages and methods of delivery differ (e.g. tablets, suppositories, soluble, all in the same medicine reflecting cultural preferences), and so on.

New directions for a productive and innovative European biopharma industry

Kuhn used the duck-rabbit optical illusion to ...

European pharma: which is it?

Recent research suggests that the European pharmaceutical industry is more productive than the US one.  Euractive reports on this here: article-184974.

A few things to consider.  Light’s work is a reanalysis of existing data.  His conclusions are based on using the head-office of the company discovering the drug as determining the country of origin.  He is trying to distinguish between drugs that are important, and add clinical value, and those that are ‘me to’ drugs.  He notes that the reimbursement system in the US favours me-to drug development.  This drives a logic that drugs that are top-selling are also important — this is the so-called blockbuster model of drug development and sales. The European Commission still thinks this is a sensible way to measure innovation.

This model is tiresome and bankrupt.  We are in paradigm shift in the medicines industry which few in policy circles seem to have noticed.  And of course the major pharmas will be the last ones to admit it.  One major pharma CEO is reported to have said that they are going to ride this baby (blockbusters) until the wheels fall off.  Well, someone should tell this person, the wheels are falling off.

Light’s point is a simple one really.  The value-add of research spending on pharmaceutical research should produce better medicines, with improved clinical value, not me-to’s.  Europe appears to be better at doing this. The Commission’s plans to work with the pharmaceutical industry should pay attention to this. Indeed, there are lots of medicines around, just not as many of the ones we really need.  And of course, big pharma isn’t the same as little pharma or biotech pharma, and the latter are the disruptive players.  Medicines are moving away from blockbuster drugs administered to millions and sold in vast quantities toward personalised medicines, focused on specific categories of patients. [Keep in mind, that in clinical trials, many of these subgroups of patients could be discarded from the trials as they were too small and skewed the studies. Now of course, by data-mining past clinical trials we can identify subgroups of patients with specific response characteristics that a tailored medicine will do.  But that doesn’t produce sales in the billions.]

Of course, Light’s work lumps all the countries of Europe together.  There are free-riders on that innovation claim, EU member states with small and probably ineffective pharmaceutical research and development capabilities, while there are a few world-class countries.  Certainly, the big players are those countries with the big companies, but also the ones with policies which make it productive for pharma research to be done in the first place, e.g. Germany, Sweden, UK. I might add France, but it isn’t particularly good at commercialisation of its research.  One could add a couple of others.  I would like to have seen the disaggregated country-by-country data, in the same way as disaggregated US data would have shown which US states are the real drivers and which are the free-riders.

In the end, comments will fall on either sides of the issue.  Industry will point to claims of innovation based on sales, while others will point to importance.  Methinks the Commission and Europe generally should align its policies around importance.  That way the goals are over quality not quantity.

Innovative medicines: it is about the patient, stupid!

The Clown

Clowning around with policy

The Innovative Medicines Initiative seeks to put right the chaotic treatment of pharmaceutical innovation by EU member states, and will likely fail.  The goose that lays golden eggs of medical innovation is cooked to death by member state medicines policies.

Increasing the speed of product development will come to a grinding halt as member states inconsistently apply economic evidence, and thereby stifle adoption of new medicines into clinical use to the benefit of patients.

Current regulatory thinking (i.e. EMEA) is dated as the priorities have moved beyond safety/efficacy issues to outcomes and cost-effectiveness.   NICE and its counterparts across Europe have yet to harmonise their methods, adding uncertainty as member states use economic evaluation as a 4th hurdle which varies in height depending on which country you’re in.  That economic evaluation is really just a code for controlling health expenditure and reimbursement, and is less about real value and outcomes in many member states only adds to chaos of the regulatory environment into which innovative products are thrown.

So, as we incentivise the early stages of medicines development and speed up the launch of drugs, we continue to tolerate a bottleneck on the utilisation and adoption of medicines themselves within member states.    The whole translational medicine process, from bench to bedside, is not just of faster benches, but of clear bedside clinical priorities.  We can incentivise the bench until the cows come home, but until we address the real disconnect between adoption and utilisation and link innovation priorities with real-world priorities, patients will still not have the medicines they need.  However, the statistics will undoubtedly show a rise in innovation!