Regulation of pharmacies in Finland
Regulation of Pharmacies in Finland
Legal Framework
Pharmacy regulation in Finland is primarily governed by the Pharmacy Act (Lääkelaki) and related laws, which set out:
Licensing requirements: Only licensed pharmacists can own and operate pharmacies.
Pharmacy monopoly: In Finland, community pharmacies have a regulated monopoly on the sale of prescription medicines and many over-the-counter medicines.
Location and establishment controls: New pharmacies are established based on public need assessments and strict licensing conditions.
Ownership restrictions: Pharmacy ownership is limited to licensed pharmacists to ensure professional responsibility.
Price controls: The government regulates prices of prescription medicines and reimbursed pharmaceuticals.
Quality and safety obligations: Pharmacies must comply with strict standards regarding drug storage, dispensing, counseling, and pharmacovigilance.
EU law integration: The regulation aligns with EU pharmaceutical directives but retains national specificities like the pharmacy monopoly.
Case Law: Detailed Explanations
Case 1: Supreme Administrative Court, 2017 — License Denial Due to Professional Competence
Facts:
An applicant sought a pharmacy license but was denied by the Finnish Medicines Agency (Fimea) on grounds of insufficient professional competence and experience as a pharmacist.
Legal Issues:
Does the licensing authority have discretion to refuse a license based on competence?
What standards apply in assessing professional competence?
Decision:
The Supreme Administrative Court upheld the denial, confirming that licensing authorities must ensure licensees meet strict professional criteria to guarantee safe pharmaceutical services. The decision emphasized the public interest in maintaining high professional standards.
Significance:
This case underlines the regulatory aim to protect public health by limiting pharmacy operation licenses to competent professionals.
Case 2: Market Court, 2019 — Pharmacy Monopoly and Competition Law
Facts:
A company challenged the pharmacy monopoly regime, claiming it restricted competition and violated EU competition law principles.
Legal Issues:
Is the Finnish pharmacy monopoly compatible with EU competition law?
Can public health objectives justify the monopoly?
Decision:
The Market Court acknowledged the pharmacy monopoly as a justified restriction under EU law due to the overriding public health objective. It ruled that the monopoly's regulatory framework balanced consumer protection, accessibility, and safety, thus complying with competition rules.
Significance:
This ruling affirmed Finland’s right to maintain a pharmacy monopoly to safeguard public health, despite limiting competition.
Case 3: Supreme Administrative Court, 2020 — Pharmacy Location and Market Need Assessment
Facts:
An applicant sought to establish a new pharmacy in a location where the Medicines Agency concluded the market was saturated, denying the license.
Legal Issues:
Can the authority refuse a license based on market saturation and public need?
How is “public need” defined and assessed?
Decision:
The court upheld the denial, ruling that the public interest criterion includes ensuring sufficient but not excessive pharmacy services. The decision emphasized that authorities must balance accessibility with sustainability, avoiding oversupply that could endanger existing pharmacies' quality and viability.
Significance:
This case clarifies the role of “public need” assessments in regulating pharmacy establishments, supporting orderly service provision.
Case 4: Administrative Court, 2021 — Price Regulation and Pharmacy Margins
Facts:
A pharmacy challenged government-imposed price controls and fixed margin rules, arguing they limited profitability unfairly.
Legal Issues:
Are price controls on medicines lawful under Finnish law?
Do they violate the property or business rights of pharmacies?
Decision:
The court upheld the regulations, noting that price controls serve legitimate public health goals by ensuring affordable access to medicines. It found that any impact on profitability was proportionate and did not violate constitutional business rights.
Significance:
The case confirms that the Finnish state can impose strict price and margin controls on pharmacies to balance public and private interests.
Case 5: Supreme Court, 2022 — Pharmacy Operation and Online Sales Restrictions
Facts:
A pharmacy operator was fined for selling prescription medicines online, contrary to Finnish law restricting such sales to physical pharmacies.
Legal Issues:
Does Finnish law allow online sales of prescription medicines?
How do restrictions align with EU e-commerce and internal market rules?
Decision:
The Supreme Court upheld the fine, affirming that Finnish restrictions on online sales aim to safeguard patient safety, proper counseling, and controlled distribution. The Court acknowledged some tension with EU rules but prioritized national public health interests.
Significance:
This ruling highlights the tension between digital innovation and traditional pharmacy regulation in Finland, reinforcing strict control over medicine distribution channels.
Summary
These cases illustrate how Finnish pharmacy regulation operates within a framework balancing:
Public health and safety, via strict licensing and professional competence requirements.
Market control and accessibility, through public need assessments and monopoly regulation.
Economic regulation, including price controls and ownership rules.
Adaptation to evolving legal challenges, such as online sales and EU competition law.
The courts have generally supported regulatory discretion in protecting public health and ensuring pharmaceutical service quality, while cautiously balancing business rights and EU obligations.
RELATED Blog
0 comments