Will Kenya amend the Anti-counterfeit act?

Commerce Department of India has asked to Kenyan legislation to make changes in its anti-counterfeit law passed last year 24 July after a stiff dispute . The Kenyan legislation lays down that all generics will be treated as counterfeits and rejected in case a patent holder in a third country files a dispute. The medicines import from India to which are also contemplating passing similar legislations

The Indian pharmaceutical industry, which supplies nearly 15% of its total exports of more than Rs 30,000 crore annually to Africa. cipla (one of the largest exporter of drug in Africa ) has pointing out that if similar legislation was adopted by other African countries as Uganda, Nigeria and Tanzania under the influence of global MNCs then export of India’s drugs to African countries will be under threat and depriving the Kenyan population access to affordable generic medicines

In a Kenya Gazette Supplement No. 50 dated 24th July 2009, the Minister gave the directive for the Act to be operational from 7th July 2009 even though on 8th July 2009, three people living with HIV filed a petition with the Constitutional Court challenging the constitutionality of the Anti-Counterfeit Act.

The petitioners said that:

1. The Act confuses counterfeits and generic medicines through inaccurate and confounding language. By noting that generic medicines are legitimate exact copies of their brand-name original, the petitioners stated “Generics are not counterfeits and should not be confused with counterfeits.

2. The Act addresses the numerous sections which contain dangerous ambiguities; their mis-interpretation would be detrimental to the government’s ongoing efforts to ensure access to essential medicines for all Kenyans.

3. A clause in act was added which specifically mentions “medicines” it is still incomplete – for example, the clause does not include vaccines. The Anti-Counterfeit Act does not distinguish medicines from other goods. “Medicines are essential and life-saving and should be distinguished from non-essential goods such as DVDs and batteries,”

4. Pharmacy and Poisons Board (PPB) which is a drug regulatory authority under the pharmacy & poison act should be in charge of combating counterfeit medicines, not the Kenya Revenue Authority (KRA).

The coordinator of the Kenya Treatment Access Movement (KETAM) argued that the

1. Act contravenes sections of the Industrial Property Act, 2001 such as Section 58(2) (providing for parallel importation) and Section 80 (government use). These sections have played an important role in the struggle to increase access to essential medicines in Kenya

2. Section 34 on seizures of suspected counterfeits goods (including medicines) is too broad

source : Economic times

Pangea II** A operation against online supply of Counterfeit Drug

The U.S. Food and Drug Administration on has completed a coordinated, weeklong (16 to 20 November 2009), international effort, called the International Internet Week of Action (IIWA).

The goal of the IIWA is to protect public health by: (1) Increasing the public's awareness about the dangers and risks associated with purchasing drugs and medical devices from Web sites (2) Identifying producers and distributors of counterfeit and illegal pharmaceutical products and medical devices (3) Targeting these individuals and businesses with civil or criminal action (4) Seizing counterfeit and illegal products and removing them from the supply chain.

The IIWA is an initiative sponsored by the International Criminal Police Organization (Interpol), the World Health Organization's International Medical Products Anti-Counterfeiting Task Force (IMPACT), the Permanent Forum on International Pharmaceutical Crime(PFIPC), and national health and law enforcement agencies from 24 countries (Australia, Austria, Belgium, Canada, the Czech Republic, Denmark, France, Germany, Ireland, Israel, Italy, Liechtenstein, Netherlands, New Zealand, Norway, Portugal, Singapore, South Africa, Spain, Sweden, Switzerland, Thailand, the UK and the US) .This coordinated International effort Operation is known as Operation Pangea II**.

Pangea II** is an operation to Combat Online Supply of Counterfeit & Illegal Medicines. Due to an ever-increasing number of websites supplying dangerous and illegal medicines, this operation was focused on three aspects of the illegal websites – 1. Internet Service Provider (ISP) 2 . Payment Systems 3 . The Delivery services, investigators revealed 751 websites engaged in illegally selling drugs, 72 of which have now been taken down. In addition to that, more than 16,000 packages were inspected by regulators and customs, 995 packages were seized and nearly 167,000 illicit and counterfeit pills including antibiotics, steroids and slimming pills were confiscate. One of the Findings from the European Alliance for Access to Safe Medicines Report 2008 revealed that 62% of medicines purchased online are fake or substandard.

Interpol secretary general Ronald K Noble said that the primary goal of Operation Pangea II was to protect the public. "We will do this by removing counterfeit and illicit medicines from the market, by shutting down illegal sales on the web, and by prosecuting those potentially putting lives of innocent consumers at risk," he said.

During the week, OCI and FDA import specialists joined with Immigration and Customs Enforcement (ICE) Customs and Border Protection ( CBP) , the Drug Enforcement Administration, and the U.S. Postal Inspection Service to target and interdict shipments of violative pharmaceutical products moving through certain International Mail Facilities (IMFs) and express courier hubs for more information buying medicine and medical product over the internet .

During the effort, the FDA’s Office of Criminal Investigations (OCI), in conjunction with the Center for Drug Evaluation and Research ( CDER )and the Office of Regulatory Affairs, Office of Enforcement, targeted 136 Web sites that appeared to be engaged in the illegal sale of unapproved or misbranded drugs to U.S. consumers. None of the Web sites are for pharmacies in the United States or Canada.

The agency issued 22 warning letters to the operators of these Web sites and notified Internet service providers (ISP) and domain name registrars that the Web sites were selling products in violation of U.S. law. In many cases, because of these violations, Internet service providers and domain name registrars may have grounds to terminate the Web sites and suspend the use of domain names.

The FDA works in close collaboration with our regulatory and law enforcement counterparts in the United States and throughout the world to protect the public,” said FDA Commissioner Margaret A. Hamburg, M.D. “Many U.S. consumers are being misled in the hopes of saving money by purchasing prescription drugs over the Internet from illegal pharmacies. Unfortunately, these drugs are often counterfeit, contaminated, or unapproved products, or contain an inconsistent amount of the active ingredient. Taking these drugs can pose a danger to consumers.