Ali & Associates is handling numerous trademark infringement cases involving identical and similar brand names of different medicines registered with the Drug Regulatory Authority of Pakistan (DRAP). DRAP is responsible for regulating and registering therapeutic goods in Pakistan, including approving brand names to ensure they are distinct and do not create market confusion. In addition to seeking approval from DRAP, companies also protect their product names by registering them as trademarks with the Intellectual Property Organization (IPO) of Pakistan. However, despite DRAP's regulatory framework, there have been instances of registrations with identical or similar brand names for different therapeutic goods, constituting a violation of intellectual property rights.
Beyond legal concerns, similar brand names pose a significant risk to patient safety. There have been numerous cases of physicians prescribing the wrong medications due to brand name confusion. Moreover, nurses and pharmacists sometimes misinterpret similar drug names when transcribing and dispensing prescriptions. This issue becomes more critical because most patients may not possess a deep understanding of medications and may fail to notice differences among brand names when making purchases. When medication errors due to similar brand names occur, patients face a range of health-related complications, including taking the wrong medication, incorrect dosages, adverse drug interactions, delayed treatments, adverse side effects, non-compliance, psychological stress, hospitalization, long-term health consequences, and more. Though rare, severe medication errors can result in fatal outcomes, particularly when administered to patients with life-threatening conditions.
As mentioned, DRAP reviews proposed brand names for drugs submitted by manufacturing companies to reduce medication errors stemming from name confusion. Nevertheless, the issue persists due to the lack of an integrated regulatory framework ensuring that new brand names for pharmaceuticals, biologicals, nutraceuticals, herbal products, medical devices, or imported medications differ from existing registered brand names to mitigate associated risks related to name confusion.
Therefore, DRAP must seek regulatory improvements and develop laws, regulations, and guidelines pertaining to pharmaceutical brand name approvals. These should include legal provisions explicitly addressing issues of similarity and the consequences of non-adherence. DRAP can implement specific measures in the pre-registration process, involving a comprehensive examination of proposed brand names to identify potential similarities with existing products. To achieve this, it should establish advisory committees comprising experts in pharmacology, medicine, pharmacy, and intellectual property, providing valuable insights and recommendations on brand name approvals and potential conflicts before product registration. Furthermore, it can collaborate with international regulatory bodies and organizations to learn from best practices in other countries and gain insights into addressing cases of brand name similarity. Most importantly, DRAP should establish swift enforcement mechanisms to promptly enforce its decisions regarding brand names, including issuing warnings, fines, or even revoking the registration of medications with deceptively similar brand names.
Manufacturers should also consider this risk before submitting proposed brand names to DRAP by seeking a trademark search report to determine whether someone has already applied for the trademark they desire. Moreover, DRAP can work with manufacturers to eliminate the use of identical or similar brand names for already registered products.
The brand name rules established by DRAP in Pakistan have given rise to trademark infringement challenges, underscoring the need for a careful and equitable approach to brand name approvals in the healthcare sector. Ensuring that brand names are unique and distinct is essential for safeguarding patient safety and intellectual property rights. Collaboration between the pharmaceutical industry, DRAP, and legal professionals is imperative to address and effectively mitigate these challenges.
