AUTHOR: UMUHOZA HORTANCE, INSTITUTE OF LEGAL PRACTICE AND DEVELOPMENT(ILPD)RWANDA

For the last decade, several investigations showed that a significant portion of medicines  sold in some pharmaceutical and drug markets  across India and Africa are counterfeit, ineffective and sometimes deadly. For example, in Rwanda, authorities seized thousands of counterfeit anti-malarial drugs, risking lives of vulnerable populations. This alarming trend underscores a critical challenge in global health: ensuring that patients access genuine, safe medicines.

The counterfeit medicines deceives and threaten both health care professionals, consumers and lead to the undermine of health care systems and pharmaceutical industries. The consequences of this phenomenon can be significant, ranging from treatment failures and exacerbation of illnesses to development of drug resistance and even loss of life.

As criminal enforcement is crucial, the role of intellectual property rights(IPR) in fight this menace  has gain recognition in India (know the pharmacy of the world ) and other different countries in Africa(such as Rwanda,Kenya, DRC, Ghana and Cameroon, etc..), proper IPR  protection is needed hence facilitate the incentivize innovation, facilitate enforcement against counterfeiters and foster international cooperation.

Today, protecting patients from counterfeit medicines through IPR (Intellectual Property Rights) is more urgent than ever because counterfeit drugs threaten global health, causing treatment failures and increasing resistance (WHO, 2020). Strong IPR enforcement helps prevent illegal manufacturing and distribution, ensuring the safety and efficacy of medicines (WIPO, 2021). Advances in technology such as serialization and digital tracking, supported by organizations like the WHO and INTERPOL, enable real-time verification of genuine products (INTERPOL, 2019). Protecting intellectual property also encourages pharmaceutical innovation, ensuring access to safe, effective treatments. Overall, robust IPR safeguards public health, reduces economic losses, and maintains trust in healthcare systems worldwide (EUIPO, 2022)

It is believed that the history of counterfeit medications date back to at least the 4th century BCE. In the CE 1st century, counterfeit medicines were identified by Dioscorides “the Greek physician,” who wrote about the detection of counterfeit drugs (WHO, 1999a,b). Recent reforms include stricter enforcement provisions and international treaties like the TRIPS Agreement, which bolster patent protections and combat counterfeit activities. However, controversies persist regarding the balance between IPR enforcement and access to medicines.

In the early 2000 there was an excess of reports on the proliferation of counterfeit medicine across Africa and who started to raise serious concerns about their risk of those products on te population’s heath, 

• IMPACT Initiative launch 2006-2010

As years pass by the falsified medicines methods got sophisticated which forced the WHO to seek a global solution considering that issue as a global challenge and raising awareness of how dangerous it is to the community.that what led to the launch of the IMPACT Initiative.

By 2006 they launched the “IMPACT Initiative”  , which intensified efforts to combat counterfeit medicine and many countries started reporting the seizure  of such products. As years passes some African countries such as Nigeria faced an outbreak of counterfeit Anti-Malaria medicine which contributed to treatment failures and increased mortality”.

• WHO Global Surveillance and  Monitoring System (GSMS)

After  the IMPACT Initiative launch there was continuous effort fray against counterfeit medicine on pharmaceuticals market .between the year of  2013 and 2015 there existed a launch of major international and national initiatives like WHO Global surveillance and Monitoring system(GSMS) which showed the surging prevalence rates in several countries in Africa, WHO issues a report showing that 10 to 20 % of medicine  in some African countries were falsified and present a serious danger to the public health.

• Recent Reforms and Controversies

Despite absolute acknowledged instruments, administration of charcoal is a challenge, abnormally in developing countries like Rwanda and India, area authoritative accommodation is limited. Recent reforms focused on deepening bound controls, agenda monitoring, and incentivizing apparent protections. However, controversies abound about the antithesis amid IPR administration and admission to affordable medicines, abnormally in low-income countries.

In India, the Patents (Amendment) Act, 2005, and consecutive regulations adequate apparent protections, adjustment with TRIPS requirements, yet debates abound over admission and affordability. Similarly, Rwanda has fabricated efforts to acclimate acknowledged frameworks but faces ability constraints

• India’s Patent Act, 1970, 

Due to  its consecutive amendments, including the 2005 Patent (Amendment) Act, aim to advance patent protections for pharmaceuticals. Section 48 of the Act empowers patentees to accomplish their rights adjoining anarchic goods, including affected medicines. Indian courts accept consistently upheld patent rights, emphasizing their emphasis in incentivizing R&D (e.g., Novartis AG v. Union of India, AIR 2013 SC 1311). The Indian Drug and Cosmetics Act, 1940, additionally criminalizes affected drugs beneath Sections 27, 28, and 33.

• Rwandan Law ,Regulations and Authorities on IPR 

Through the law provides the primary legal basis for regulating pharmaceuticals, including provisions against counterfeit product. The law mandates licensing, quality control, and sanctions for violations. Additionally, Rwanda’s Law on Intellectual Property Rights offers protections for trademarks and patents, which are essential in identifying genuine medicines and deterring counterfeiters.

Enforcement agencies such as the Rwanda Food and Drugs Authority (Rwanda FDA) oversee market surveillance and licensing, while the Rwanda National Police and Revenue Authority play roles in enforcement and customs controls through several Through different operation such as Operation MambaII with collaboration with other East African Countries and Interpol they seize tons of counterfeit medicines, Operations dubbed Fagia OPSON led to the seizure of illicit products worth Rwf 14 million respectively and similar operation continue to be executed in the following years

Rwanda is also a signatory to international treaties like the TRIPS Agreement and WIPO treaties, which bolster its legal capacity to protect IPR and combat counterfeit medicines.

Rwanda’s Law No. 30/2018 on Intellectual Property aligns with the African Regional Intellectual Property Organization (ARIPO) protocols. It provides for Patent protections, brand enforcement, and penalties for affected medicines. However, administration accommodation is charcoal limited, and the acknowledged framework is still evolving.

 Relevant Case Laws

India: 

Novartis AG v. Union of India (2013)

 The Supreme Court alone made an apparent appeal for an adapted adaptation of an accepted drug, emphasizing that patents should not be accepted for accessory modifications that do not accommodate adroit footfall criteria. This case allowed the accent of apparent rights but additionally accentuated the charge to anticipate barmy patents that could arrest admission to affordable medicines.

International  

The European Court of Justice in “Pfizer v. Sandoz” (2017) states that a biosimilar biologic infringes on patents if it copies the patented molecule, emphasizing the emphasis of IPR administration in biosimilars.

Rwandan Case Law  

While specific Rwandan jurisprudence on affected medicines is limited, contempo cases absorb access and abolition of affected goods, emphasizing the emphasis of able-bodied enforcement.a lot has been done by government with collaboration with every concerned authority in the country  for the protection of the population.

“since 2008, RNP participated in Interpol led operations dubbed Mamba (2008), Wipe Out (June 2014) and Opson-Fagia (December) in which counterfeit and illegal pharmaceuticals were seized”

Rwandan ministry of health (MOH) in their National strategic Plan(2018-2024) in the section of quality assurance they included the”  the systems to track and trace products in the national supply chain will be considered in order to minimize or avoid counterfeit products being used”.

Rwanda begins implementing serialization and barcoding systems for medicines to adviser accumulation chains effectively. This aligns with bounded efforts beneath the East African Community (EAC) to action affected drugs.

Rwanda's Bureau of Standards verifies certification documents and, together with the Customs Services Department and the Ministry of Health, inspects each shipment of drugs upon importation into the country”.

Until now Rwandan government is progressively implementing and updating the counterfeit medicine combat as it matters for their community security and health

• Balancing Addition and Access  

Proponents alter that able IPR protections to incentivize biologic addition and allure investments. Conversely, critics argue that boundless administration can allow absolute admission to affordable medicines, abnormally in developing countries. The agitation is decidedly astute apropos capital medicines like antimalarials and HIV/AIDS drugs.

• Public Health vs. IPR  

The TRIPS abandonment angle during the COVID-19 communicable exemplifies this tension, with advocates advancing waivers to acquiesce to all-encompassing production, while opponents accent the charge to assure apparent rights to sustain innovation.

International Comparisons

The EU’s access is characterized by absolute bound controls, binding notification systems, and austere penalties, which accept accurate and adjoining affected medicines. In contrast, abounding developing countries await heavily on bent sanctions and abridgement acceptable infrastructure, arch to assiduous problems.

 Challenges 

• Administration Gaps

Despite acknowledged provisions, administration of charcoal is inconsistent. In Rwanda, bound assets impede bound surveillance; in India, the all-inclusive calm bazaar complicates enforcement. Counterfeiters generally accomplish authoritative gaps, abnormally in online sales.

• Adverse Judgments and Legal Ambiguities

Courts sometimes face adverse judgments apropos apparent authority and infringement, arch to uncertainty. For example, in India, the “Novartis case” has antiseptic patentability standards, but ambiguities abide in the case of accessory patents.

• Cross-Border Challenges

Counterfeit medicines generally arise from or alteration through assorted jurisdictions, complicating enforcement. Abridgement of all-embracing allocation can arrest action, abnormally adjoin organized transnational affected networks.

• Public Acquaintance and Consumer Protection

Consumers generally abridgement acquaintance of affected risks,  authoritative them accessible to ambiguous marketing. The admeasurement of online pharmacies exacerbates this issue.

Suggestions 

• Strengthening Legal Frameworks

by harmonizing civic laws with all-embracing standards such as TRIPS and bounded agreements like ARIPO and Enact specialized legislation targeting biologic counterfeiting, including accoutrement for agenda enforcement.

• Enhancing Administration and Surveillance

through Invest in bound ascendancy infrastructure, surveillance technology, and training, promote the use of blockchain and serialization to cure medicines through accumulation chains and Establish specialized courts for bookish acreage and biologic cases.

• All-embracing Cooperation

Strengthen cross-border accord through INTERPOL’s I-Check programme and WHO’s IMPACT initiative, Share intelligence and best practices amid countries, abnormally amid India, Rwanda, and added developing nations.

• Accessible Acquaintance and Consumer Engagement

The Launch acquaintance campaigns about risks associated with affected medicines and regulate online pharmacies and advance absolute sources.

• Balancing IPR and Accessible Health

Implementation and flexibilities such as compulsory licensing beneath TRIPS during bloom emergencies. Advance apparent pooling and autonomous licensing to advance admission to capital medicines.

Counterfeit medicines abide to affectation, a cogent blackmail to all-around health, abrasive assurance in healthcare systems and endangering lives. While able-bodied acknowledged frameworks abiding in IPR are acute in combatting this menace, administration challenges, abstruse advancements, and action debates complicate the landscape. Countries like India and Rwanda body efforts to adjust civic laws with all-embracing standards, but ability limitations and administration gaps remain.

Protecting patents and trademarks not alone incentivizes biologic addition but additionally acts as a bridle adjoining counterfeiters. Ultimately, attention to patients' bloom requires an aerial antithesis amid able-bodied IPR administration and ensuring admission to affordable medicines. As the action adjoining affected medicines intensifies, the role of IPR will be cardinal in creating a safer, convalescent world for creation and inventions.

• World Trade Organization. Agreement on Trade-Related Aspects of Intellectual Property Rights (TRIPS), 1994.

• Supreme Court of India. Novartis AG v. Union of India, AIR 2013 SC 1311.

• India. Patent Act, 1970, amended 2005.

• India. Drugs and Cosmetics Act, 1940.

• Rwanda. Law No. 31/2009 of 26/10/2009 on the Protection of Intellectual Property.

• World Health Organization. Counterfeit Medical Products: Policy Brief, 2017.

• European Medicines Agency. Guidelines on Preventing Counterfeit Medicines, 2020.

• INTERPOL. I-Check Programme for Combating Counterfeit Medicines, 2019.

• African Regional Intellectual Property Organization (ARIPO). Harare Protocol, 2014.