Brexit consequences on UK medicines shortages may be more complex and less predictable than anticipated
A recent BMJ news warns about the possible consequences of Brexit for medicines shortages in the UK (Iacobucci, 2018). Medicines shortage is nonetheless a worldwide and persistent health crisis (WHO, 2016). Factors contributing to medicines shortage include production and reimbursement problems, as well as product withdrawal, however additional factors may be involved which are not yet completely understood. For instance, a recent study showed that in the USA between 2015 and 2016 prices for medicines with a shortage increased more than twice in comparison to those without a shortage, suggesting that manufacturers' opportunistic behavior may also contribute (Hernandez et al., 2018).
Several lines of evidence suggest that in the European Union a primary source for medicines shortage is parallel import (also called parallel trade or parallel distribution). According to the World Trade Organization, "parallel import" is "when a product made legally (i.e. not pirated) abroad is imported without the permission of the intellectual property right-holder (e.g. the trademark or patent owner)" (https://www.wto.org/english/thewto_e/glossary_e/glossary_e.htm). The EU protects and promotes parallel import as a way to promote competition and trade. Prices for medicines are however widely different from one EU country to the other, and as a result low-price countries like Greece, Poland and Italy are convenient locations for buying cheap products for re-export, while in high-price countries like Nederlands, Sweden, Denmark and United Kingdom the penetration of parallel import is rapidly growing (Bernini, 2014). Thus, while parallel import has been suggested as the most likely cause of continuing drug shortages e.g. in Italy (APMHealthEurope.com, 2018), parallel import-generated savings to UK health budgets had been estimated 342 millions Euro in 2003 and 237 millions Euro in 2004 (reported by Morgan, 2008). Others however suggested that parallel import may generate only moderate savings to health budgets, while leading to product shortages in exporting countries and possibly also a higher probability of counterfeiting (Kanavos and Kowal, 2008). On the other side, the Association of the British Pharmaceutical Industry already in 2008 complained of £ 1.2 bn less revenues due to parallel import (reported by Morgan, 2008).
As a whole, it is of course possible that Brexit will worsen drug shortages in the UK, however consequences are likely to be more complex and possibly less predictable than anticipated. For instance lorazepam, which is mentioned as an example of latest shortage in UK (Iacobucci, 2018) was already missing in UK several years ago (de Monteverde-Robb et al., 2011), and - by the way - is presently also included in the italian medicines shortage list, together with nearly 2000 other medicinal products (http://www.agenziafarmaco.gov.it/content/carenze-e-indisponibiltà). Meanwhile, the European Union should possibly examine in more detail the consequences of free parallel import in light of the peculiarities of medicinal products and their market. Thorough research about mechanisms and consequences of parallel import of medicines as well as more in general about the mechanisms leading to medicines shortage would help evidence-based regulation of medicines trade in the public interest.
References
APMHealthEurope.com. Parallel trading most likely cause of Italy’s continuing drug shortages. APMHealthEurope.com Press review - Friday 13 July 2018 (URL: https://www.apmhealtheurope.com/freestory/0/59457/parallel-trading-most-..., last accessed: 30th september 2018).
Bernini C. Medicines shortages: an European overview? Pharma World Magazine, 4 april 2014 (URL: http://www.pharmaworldmagazine.com/medicines-shortages-an-european-overv..., last accessed: 30th september 2018).
de Monteverde-Robb DJ, Allen CM, Damian MS, Manford MR, Burnstein RM, Gunning KE, Menon DK. Where has all the lorazepam gone? BMJ 2011, 343: d5955.
Hernandez I, Sampathkumar S, Good CB, Kesselheim AS, Shrank WH. Changes in Drug Pricing After Drug Shortages in the United States. Ann Intern Med 2018 Sep 18. doi: 10.7326/M18-1137. [Epub ahead of print]
Iacobucci G. Harmful drug shortages will worsen after Brexit, doctors warn. BMJ 2018, 362: k4040.
Kanavos P, Kowal S. Does pharmaceutical parallel trade serve the objectives of cost control? Eurohealth 2008, 14(2): 22-26.
Morgan O. Parallel trade in drugs puts EU patients at risk. The Guardian, Sun 29 Jun 2008 (URL: https://www.theguardian.com/business/2008/jun/29/pharmaceuticals, last accessed: 30th september 2018).
WHO. Medicines shortages - Global approaches to addressing shortages of essential medicines in health systems. WHO Drug Information 2016, 30(2): 180-185.
Rapid Response:
Brexit consequences on UK medicines shortages may be more complex and less predictable than anticipated
A recent BMJ news warns about the possible consequences of Brexit for medicines shortages in the UK (Iacobucci, 2018). Medicines shortage is nonetheless a worldwide and persistent health crisis (WHO, 2016). Factors contributing to medicines shortage include production and reimbursement problems, as well as product withdrawal, however additional factors may be involved which are not yet completely understood. For instance, a recent study showed that in the USA between 2015 and 2016 prices for medicines with a shortage increased more than twice in comparison to those without a shortage, suggesting that manufacturers' opportunistic behavior may also contribute (Hernandez et al., 2018).
Several lines of evidence suggest that in the European Union a primary source for medicines shortage is parallel import (also called parallel trade or parallel distribution). According to the World Trade Organization, "parallel import" is "when a product made legally (i.e. not pirated) abroad is imported without the permission of the intellectual property right-holder (e.g. the trademark or patent owner)" (https://www.wto.org/english/thewto_e/glossary_e/glossary_e.htm). The EU protects and promotes parallel import as a way to promote competition and trade. Prices for medicines are however widely different from one EU country to the other, and as a result low-price countries like Greece, Poland and Italy are convenient locations for buying cheap products for re-export, while in high-price countries like Nederlands, Sweden, Denmark and United Kingdom the penetration of parallel import is rapidly growing (Bernini, 2014). Thus, while parallel import has been suggested as the most likely cause of continuing drug shortages e.g. in Italy (APMHealthEurope.com, 2018), parallel import-generated savings to UK health budgets had been estimated 342 millions Euro in 2003 and 237 millions Euro in 2004 (reported by Morgan, 2008). Others however suggested that parallel import may generate only moderate savings to health budgets, while leading to product shortages in exporting countries and possibly also a higher probability of counterfeiting (Kanavos and Kowal, 2008). On the other side, the Association of the British Pharmaceutical Industry already in 2008 complained of £ 1.2 bn less revenues due to parallel import (reported by Morgan, 2008).
As a whole, it is of course possible that Brexit will worsen drug shortages in the UK, however consequences are likely to be more complex and possibly less predictable than anticipated. For instance lorazepam, which is mentioned as an example of latest shortage in UK (Iacobucci, 2018) was already missing in UK several years ago (de Monteverde-Robb et al., 2011), and - by the way - is presently also included in the italian medicines shortage list, together with nearly 2000 other medicinal products (http://www.agenziafarmaco.gov.it/content/carenze-e-indisponibiltà). Meanwhile, the European Union should possibly examine in more detail the consequences of free parallel import in light of the peculiarities of medicinal products and their market. Thorough research about mechanisms and consequences of parallel import of medicines as well as more in general about the mechanisms leading to medicines shortage would help evidence-based regulation of medicines trade in the public interest.
References
APMHealthEurope.com. Parallel trading most likely cause of Italy’s continuing drug shortages. APMHealthEurope.com Press review - Friday 13 July 2018 (URL: https://www.apmhealtheurope.com/freestory/0/59457/parallel-trading-most-..., last accessed: 30th september 2018).
Bernini C. Medicines shortages: an European overview? Pharma World Magazine, 4 april 2014 (URL: http://www.pharmaworldmagazine.com/medicines-shortages-an-european-overv..., last accessed: 30th september 2018).
de Monteverde-Robb DJ, Allen CM, Damian MS, Manford MR, Burnstein RM, Gunning KE, Menon DK. Where has all the lorazepam gone? BMJ 2011, 343: d5955.
Hernandez I, Sampathkumar S, Good CB, Kesselheim AS, Shrank WH. Changes in Drug Pricing After Drug Shortages in the United States. Ann Intern Med 2018 Sep 18. doi: 10.7326/M18-1137. [Epub ahead of print]
Iacobucci G. Harmful drug shortages will worsen after Brexit, doctors warn. BMJ 2018, 362: k4040.
Kanavos P, Kowal S. Does pharmaceutical parallel trade serve the objectives of cost control? Eurohealth 2008, 14(2): 22-26.
Morgan O. Parallel trade in drugs puts EU patients at risk. The Guardian, Sun 29 Jun 2008 (URL: https://www.theguardian.com/business/2008/jun/29/pharmaceuticals, last accessed: 30th september 2018).
WHO. Medicines shortages - Global approaches to addressing shortages of essential medicines in health systems. WHO Drug Information 2016, 30(2): 180-185.
Competing interests: No competing interests