Why prescription drugs have different rules in different countries

Prescription drug regulations vary widely across the globe, so a medication that’s readily accessible in one country might be tightly restricted in another. This could be extremely dangerous for someone needing drugs while in a new country. Access to vital medication can depend on the country’s governmental policies, healthcare systems, and even cultural beliefs.

Why do the rules around prescription drugs differ so much from one country to another? In this article, we’ll look at the underlying reasons behind these differences, shedding light on why prescription drug policies look so different across the globe.

Why do prescription drug regulations vary?

Prescription drug rules between countries are dependent on a multitude of factors. Even commonly used medication at home may be looked at in a completely different way when in a new country. Three dominating contributors to these variances are likely to be a country’s healthcare system, a cultural attitude toward medicine and standing legal practices.

Healthcare Systems and Accessibility

One of the biggest contributors to global prescription differences is each country’s healthcare system and the accessibility of the substances. The UK’s National Healthcare Service’s government-funded system generally has regulations to manage costs and ensure everyone has access to the medication they need.

Countries with predominantly private healthcare systems, such as the United States, may see fewer restrictions on some prescription drugs. This can result in easier access to medications but often comes with a higher cost to the patient. Research from 2022 shows that prescription drug prices in the U.S. are 2.7 times more expensive than the average of 33 other nations.

Overuse of medication in low- and middle-income countries

Overuse of medications in low- and middle-income countries is something not many of us ever have to worry about, yet it plays a major role in how easy it is to access prescription drugs.

Research highlights this in a survey of 5 million prescriptions across 80 low- and middle-income countries. Of the 367 studies, up to 80% reported on the extent of overuse of medications. Commonly overused drugs include antibiotics, psychotropics and antihypertensives. The factors driving this overuse included limited knowledge of the dangers, poor regulations and financial influences.

Cultural attitudes and perspectives on medication

Aside from healthcare systems and drug access, a nation’s cultural view on medication can heavily shape regulations on prescription medications. Different cultural groups have used drugs in distinct ways throughout history, with each holding their own social norms and practices around their use.

Historical perspectives on medication still affect the way we view drugs today and may relate to a nation’s deeper beliefs on health, spirituality and sense of community. Outlined below are some examples of the varying perspectives and cultural beliefs toward medication that affect prescription views between countries:

U.S. perspective on prescriptions, including opioids

Compared to European rates, there’s a high level of prescriptions happening in the U.S. for pain relief, especially with opioids. Research shows that compared to their European counterparts,  U.S. healthcare providers prescribe opioids more frequently, at higher doses and throughout more stages of treatment for pain, including as first-time treatment.

The U.S. also generally allows healthcare providers more direct marketing, with decentralised prescription drug monitoring programmes (PDMPs). More intense marketing may be contributing to a higher reliance on pharmacological treatments in the U.S.

paitent with medicine in hand

Japan’s conservative approach

Prescriptions for severe and chronic pain often include opioids. Japan consistently has one of the lowest per-capita opioid consumption in the developed world. This is surprising, given Japan’s rapidly ageing population. Japan’s older citizens deal with diseases and ailments of ageing, such as arthritis, cancer and diabetic nerve damage.

Japan can be seen to have a comparatively cautious approach to opioid prescriptions, influenced by a restrictive healthcare approach and cultural attitudes. Opioids are usually reserved for the most severe cases, with many Japanese preferring non-drug pain management techniques.

Netherlands and preventive care

In the Netherlands, as well as many parts of Europe, a cultural focus is placed on balancing medication with preventive practices. The Netherlands’ 2023 Health Profile shows that their mortality rates from preventable and treatable causes are 21% and 36% lower than the EU average, respectively.

The Netherlands’ cultural focus on integrating wellness with reduced dependency on prescription drugs likely has a bearing on the country’s drug regulations and rates of prescription.

Legal frameworks and government policies

Every country holds its own rules and agencies that decide how medications are approved and used by its people. These approaches reflect the nation’s priorities and its legal system’s structure.

Most of Europe uses The European Medicines Agency (EMA) to handle the approval of drugs across EU nations. With its headquarters in Amsterdam, the EMA’s approval of medication makes it accessible throughout most of Europe. The centralised process speeds up distribution and keeps prices relatively affordable. The EMA works closely with national health services to create stability for people accessing prescriptions across Europe.

The U.S. governing body is the FDA (Food and Drug Administration), which makes sure each drug goes through a lengthy and thorough process of review. A large governing body like the FDA can more easily prioritise the safety of U.S. citizens, though there can be longer wait times for medications to enter U.S. markets. The FDA also largely monitors and regulates prescription drug ads, forcing manufacturers to be more upfront about any potential side effects.

On a larger, global level, agreements like the UN’s Single Convention on Narcotic Drugs strive for common standards on controlled substances. These global agreements try to balance access with control for as many people as possible, making global medicine more readily available while still aiming to minimise substance misuse.

While these laws and regulations provide a framework and a point of reference, each country still interprets prescription laws in its own way. Application of the rule of law means you may find big differences in how you get prescription drugs in different parts of the world.

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(Click here to see works cited)

  • International Prescription Drug Price Comparisons: Estimates Using 2022 Data | Rand, www.rand.org/pubs/research_reports/RRA788-3.html
  • Albarqouni L, Palagama S, Chai J, Sivananthajothy P, Pathirana T, Bakhit M, Arab-Zozani M, Ranakusuma R, Cardona M, Scott A, Clark J, Smith CF, Effa E, Ochodo E, Moynihan R; & the Overdiagnosis and Overuse of Healthcare Services in LMICs Network. Overuse of medications in low- and middle-income countries: a scoping review. Bull World Health Organ. 2023 Jan 1;101(1):36-61D. doi: 10.2471/BLT.22.288293. Epub 2022 Oct 31. PMID: 36593777; PMCID: PMC9795388.
  • Consumption of Prescription Opioids for Pain – CRS Reports, crsreports.congress.gov/product/pdf/R/R46805
  • Fahd Alogaili a, et al. “Prescription Drug Monitoring Programs in the US: A Systematic Literature Review on Its Strength and Weakness.” Journal of Infection and Public Health, Elsevier, 18 July 2020, www.sciencedirect.com/science/article/pii/S1876034120305657.
  • High Incidence of Severe Pain Is Associated with Low Opioid Availability in Patients with Advanced Cancer: A Nationwide Questionnaire Survey in Japan – the Lancet Oncology, www.thelancet.com/journals/lanonc/article/PIIS1470-2045(22)00411-9/fulltext
  • OECD/European Observatory on Health Systems and Policies (2023), Netherlands: Country Health Profile 2023, State of Health in the EU, OECD Publishing, Paris, https://doi.org/10.1787/3110840c-en.
  • “Medicines.” European Medicines Agency (EMA), www.ema.europa.eu/en/medicines
  • Center for Drug Evaluation and Research. “Prescription Drug Advertising: Questions and Answers.” U.S. Food and Drug Administration, FDA, www.fda.gov/drugs/prescription-drug-advertising/prescription-drug-advertising-questions-and-answers
  • Single Convention on Narcotic Drugs, 1961, www.unodc.org/pdf/convention_1961_en.pdf
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