Pharmaceutical Litigation and Dispute Resolution in Georgia
The pharmaceutical sector is one of the most strictly regulated and high-risk industries, where legal disputes often involve millions in damages or significant reputational harm. Pharmaceutical litigation covers a wide range of disputes: from appealing fines imposed by regulatory bodies to civil liability issues related to drug quality. In Georgia, where healthcare regulations are constantly being refined and tightened (e.g., introduction of reference pricing, mandatory GMP standards), pharmaceutical companies, pharmacies, and distributors need strong legal protection to maintain their commercial interests and licenses.
Legal.ge offers access to experienced lawyers specializing in pharmaceutical litigation. Our platform's specialists possess deep knowledge in both administrative and civil proceedings, which is critical during disputes with Ministry of Health regulations or contractors. Whether it is a licensing dispute, intellectual property infringement, or damage compensation, our lawyers ensure professional defense of your positions.
What Does Pharmaceutical Litigation Service Cover?
This service covers all types of legal conflicts that may arise during pharmaceutical activities:
- Administrative Disputes: Appealing decisions, protocols, and fines (e.g., price violations, non-prescription sales) of the Regulation Agency for Medical and Pharmaceutical Activities in court.
- Product Liability: Defense against lawsuits related to medication side effects, quality defects, or labeling errors.
- Commercial Disputes: Disputes between manufacturers, distributors, and pharmacies regarding breach of supply contracts, non-payment, or violation of exclusivity terms.
- Intellectual Property Disputes: Litigation related to patent infringement, particularly between original and generic drug manufacturers.
- State Procurement Disputes: Appealing disqualification in tenders or a competitor's victory at the Dispute Resolution Board and in court.
- Labor Disputes in Pharma Sector: Specific labor disputes (e.g., pharmacist liability, non-compete clauses).
Common Situations and Scenarios
One of the most current scenarios is violation of reference pricing. The state sets a price ceiling, and if a pharmacy or distributor sells above this limit, the Agency fines the company. Often, this is caused by a technical error or unclear regulation. In such cases, a lawyer appeals the administrative act, proving the company's innocence or requesting mitigation of liability.
Another common case is the threat of license suspension. If an inspection reveals violations of psychotropic medication recording rules in a pharmacy, the regulator may suspend authorization. This is devastating for business. A pharmaceutical law attorney requests the court to suspend the act's effect until the dispute is resolved, allowing the business to continue operations.
Georgian Legislation and Legal Framework
Crucial in pharmaceutical disputes is the Law of Georgia on Medicines and Pharmaceutical Activities, which defines types of violations and sanctions. Administrative disputes proceed according to the General Administrative Code of Georgia and the Administrative Procedure Code. In the commercial part, the Civil Code of Georgia applies.
Regarding product liability, the Code on Product Safety and Free Movement is important, defining the manufacturer's obligations for damage compensation. For state tenders, the Law on State Procurement is used. The role of a specialized lawyer is the complex analysis of these laws in the client's favor.
Process of Receiving Services
The process begins with studying case materials (protocols, contracts, orders). Legal.ge specialists assess the dispute's perspective and risks. In administrative disputes, the first stage is often filing an administrative complaint with the superior body (e.g., Ministry of Health), and in case of a negative outcome — filing a lawsuit in court. In private disputes (B2B), emphasis is placed on negotiation and mediation to avoid lengthy court proceedings, though if necessary, the lawyer fully represents the client in all three instances.
Legal.ge allows you to protect your pharmaceutical business from unforeseen financial and legal blows.
Why Choose a Specialist on Legal.ge?
General profile lawyers often struggle to understand the specifics of pharmaceutical regulations (drug forms, regimes, prescriptions). On Legal.ge, you will find specialists with experience specifically in the healthcare and pharma sectors. They are familiar with the regulator's practice and judges' approaches to similar cases, increasing your chances of victory.
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