Unlike many other professions, medicine is regulated nationally rather than internationally. While fields like finance or logistics operate under globally recognized standards, medical regulation varies by country. In this section, we’ll explore the different levels of jurisdiction and how they impact medical practice.
International Regulation
In the absence of a centralized global authority for medicine regulation, most countries rely on their own state, national, and federal frameworks. While organizations like the World Health Organization (WHO) provide global guidance, they do not have enforcement power. WHO has consistently expressed concern over the growing risks posed by unregulated online medicine sources.
Despite widespread awareness efforts, many unregulated websites continue to operate, creating serious safety risks for patients. These include:
- No assurance that the product received matches what was ordered
- Unknown origin, manufacturing practices, or storage conditions
- Suppliers with no verified qualifications or regulatory authorization
- Medications that may be inappropriate, unsafe, or interact with other drugs
- Misuse of personal or medical data
- Misuse of payment card information
European Union (EU)
The EU has made strides toward a more integrated healthcare infrastructure through the eHealth Digital Service Infrastructure (eHDSI). This initiative supports the secure cross-border exchange of health data, including patient summaries and electronic prescriptions (ePrescriptions).
The European Commission provides a common ICT platform and core services—covering interoperability, terminology standards, and more—while EU countries implement national-level systems known as “generic services.” These are coordinated through National Contact Points for eHealth (NCPeH) and receive financial backing from the Connecting Europe Facility Telecom Programme (2015–2020).
United Kingdom
In the UK, the General Pharmaceutical Council (GPhC) oversees online pharmacies and has increasingly focused on safety standards comparable to those of traditional pharmacies.
A landmark document released in September 2019, “Taking action on unsafe supply of high-risk medicines online”, targeted the irresponsible online sale of habit-forming medicines like codeine. The GPhC criticized practices such as:
- Use of online questionnaires without access to medical history
- Lack of patient consent to contact their GP
- Absence of safeguards and proper risk management
In late 2022, the GPhC issued a further alert titled “Advice to pharmacists about risks relating to online services.” It revealed that over 30% of open Fitness to Practise cases were linked to online pharmacy operations—far disproportionate to the sector’s market share. Seven interim orders were issued against pharmacists involved in online prescribing services, citing major concerns such as:
- Prescribing beyond the professional’s legal or clinical scope
- Prescribing high-risk or monitoring-required medications without adequate oversight
- Dispensing solely based on online forms, without any direct patient interaction
- Large volumes of prescriptions are issued rapidly and outside the prescriber’s area of expertise
In February 2025, the GPhC further updated this guidance to enhance patient safety, particularly concerning high-risk medications like weight-loss drugs. The revised guidelines mandate that prescribing decisions for such medications cannot rely solely on online questionnaires. Instead, prescribers must independently verify patient information—such as weight, height, and body mass index (BMI)—through methods like video consultations, access to clinical records, or direct communication with other healthcare providers. This measure aims to prevent the inappropriate supply of medications and ensure they are clinically appropriate for the patient.
Additionally, the guidance emphasizes the necessity of two-way communication between prescribers and patients for all online prescribing, allowing for thorough discussions about treatments and informed decision-making. Online pharmacies are also required to adhere strictly to laws and guidelines on the advertising and promotion of medicines, working closely with regulatory bodies like the Medicines and Healthcare Products Regulatory Agency (MHRA) and the Advertising Standards Authority (ASA) to prevent inappropriate advertising practices.
Conclusion
Building an online prescribing portal is just the beginning. To operate sustainably, it’s essential to understand and comply with both international and regional regulatory requirements.
Start with a thorough risk assessment for each jurisdiction to determine what can and cannot be prescribed. Next, ensure you meet all compliance obligations—this may include implementing systems to verify patient identity and age, and identifying those at higher medical risk due to comorbidities. Finally, staying compliant in an evolving regulatory landscape requires ongoing alignment with Best Practice. This includes maintaining up-to-date Standard Operating Procedures (SOPs) and implementing a robust Quality Management System (QMS).
References
1 Electronic cross-border health services. https://ec.europa.eu/health/ehealth/electronic_crossborder_healthservices_en
2 Taking action on unsafe supply of high-risk medicines online. GPhC: https://www.pharmacyregulation.org/regulate/article/taking-action-unsafe-supply-high-risk-medicines-online
