Weakened Patent Protection Impacts Pharmaceutical Product Safety

Patent standards have an impact on patient safety. Appropriate patent protection and regulation and good pharmaceutical production standards and quality are closely linked. When consumers are prescribed a patented medicine they can be assured that the product has been thoroughly tested for safety and efficacy and that it is produced using the highest manufacturing standards. Weakening patent protection by issuing a compulsory license to allow generic manufacturers to copy patented medicines contributes to the proliferation of sub-standard and counterfeit medicines.

What is Compulsory Licensing?

Compulsory licensing occurs when a government allows someone else to produce a patented product or process without the consent of the patent owner. Compulsory licensing is essentially the expropriation of someone else's intellectual property. Compulsory licenses allow generic manufacturers (often with little or no oversight in developing or middle income countries) to make and sell copies of a patented drug in a country that has granted the compulsory license.

Patent Protection and Patient Access to safe medicines

Weakening patent rules and expropriating or failing to protect intellectual property does little to expand drug coverage for patients who lack access to medicines. In fact, there is evidence that weak patent rules often contribute to the entry into the market place of sub-standard or counterfeit products.
Countries with weak patent rules have been linked on many occasions with sub-standard products. According to a recent OECD report, India is the number one source of counterfeit medicines (followed by Saudi Arabia and China).

India

Until 2005, only the manufacturing process, not the products themselves were covered by patents under Indian law. This gave Indian generic drug manufacturers an enormous advantage and allowed them to create generic versions of new drugs years before the patent had expired. When India changed its patent laws in 2005 to bring them into compliance with the World Trade Organization, even the Indian government recognized "that because of the country's strong pharmaceutical and biotechnology industries, it might stand to gain more than it would lose from strengthened patent protection."

According to the World Health Organization (WHO), counterfeiting is greatest in those regions where the regulatory and legal oversight is weakest. India still lacks the necessary infrastructure to ensure that the products they produce are up to standard. India only employs 35 drug inspectors at the national level and little more than one thousand spread across India's 28 states. An expert Committee in India said "the regulatory system is plagued by inadequate drug testing, a severe shortage of drug inspectors, and lack of enforcement. "The infrastructure in some states is pathetic," said Dr Raghunath Mashelkar, director general of India's Council of Scientific and Industrial Research and head of the expert committee."

According to the WHO, in 2002 India's pharmaceutical companies suggested that in India's major cities, one in five medicines sold was a fake. The industry also estimated that illegal drugs had grown from 10% to 20% of the total market.
Recently, Ethiopia withdrew the licenses of 60 generic manufacturers from India because of extensive evidence that they were providing sub-standard products.
A recent European Commission report claimed that India was the largest source of the 2.7 million counterfeit drugs seized by its customs department in 2006.
In 2003, most of the counterfeit medicines in Nigeria originated in India, a fact that led the Nigerian authorities to threaten to ban the import of all drugs from India.

Given the high number of counterfeit medicines produced in India, patients in the country are never sure if the drug they receive from the pharmacist is real or counterfeit, and experts say that millions of people in India each day are sold counterfeit medicines: "Dr. Sanjiv Zutshi, a New Delhi physician, thinks nearly anybody in India who receives medication is taking a gamble. 'I think it must be 20 to 30 per cent of the drugs might be counterfeit or sub-standard in that nature' he said. "

The role of Indian generic drug manufacturers in developing countries

India is the fourth largest producer of pharmaceuticals by volume, and given its previously lax patent laws, it produces much of the worlds' cheaper generic versions of medicines. According to Medecins Sans Frontieres, "Over half the medicines currently used for AIDS treatment in developing countries come from India and such medicines are used to treat over 80 per cent of the 80,000 AIDS patients in Médecins Sans Frontières projects today."

However, Indian generic companies, like any other companies are driven by profit.

India expropriated Glivec for the stated purpose of lowering the price for cancer patients, yet 99 per cent of patients in India receiving Glivec obtained the drug for free under a compassionate use program sponsored by the manufacturer.
When an Indian generics company introduced a version of Abbott's Aluvia that was more suited to tropical temperatures, it sold this generic version in Africa at a price three times what Abbott, the original patent holder, sells it for.
In India, the home of over 20,000 generic manufacturers, only 5 per cent of research and development funds are used for research into diseases primarily affecting the poor. The research focus of Indian generic manufacturers is on the richer markets, not on making treatments more affordable for those who are less affluent.

The recent conviction and execution of China's drug safety watchdog for ignoring safety standards is a signal that even China, a country well known for its disregard for intellectual property protection, is beginning to recognize the importance of establishing and enforcing standards.