The proliferation of substandard, dangerous medicines in poor countries is being used by rich countries as an excuse to tighten intellectual property rules, boosting the profits of large pharmaceutical companies while making it harder for poor people to get access to the medicines they need, according to a report published today by international agency Oxfam.
Eye on the Ball, launched at a high-level conference hosted by INTERPOL and the World Intellectual Property Organization in Paris, argues that improved regulation of medicines by poor countries, not enforcement of intellectual property rules, is the best way to ensure safe, effective, quality medicines.
More than 2 billion people lack regular access to affordable and quality medicines. The World Health Organization estimates that 30 per cent of countries have no functioning drug regulatory authorities. While there is no conclusive data regarding the prevalence of substandard and falsified medicines in the developing world, studies indicate that in some countries as much as 44 per cent of certain types of medicines, such as anti-malarials, are substandard.
Rich countries express concern about this real threat to public health, but they propose actions that will do little to address this problem. Specifically, they propose the enactment in poor countries of expanded intellectual property rules to reduce the availability of counterfeit products that criminally infringe trademarks. Yet anti-counterfeit measures are limited in scope and fail to address the broader public health problem of substandard and falsified medicines which pose a danger to public health but do not necessarily infringe intellectual property rights. Worse, new anti-counterfeit measures will stifle the production of and trade in low-cost generic medicines.
Invest in better drug regulation – not anti-counterfeit measures
Oxfam is calling on rich countries to abandon their focus on expanded intellectual property protection and instead provide funds to support drug regulation in poor countries.
Rohit Malpani, Oxfam senior policy adviser, said: “Poor countries are facing a crisis of substandard and falsified medicines that can harm or even kill those who take them.
“Yet rather than help poor countries address the problem to ensure safe, effective and quality medicines for all, rich countries are putting commercial interests ahead of public health in these countries.
“The European Union and the United States continue to focus almost exclusively on eliminating counterfeit medicines which form only a small part of this public health problem – but which are a serious concern for their multinational companies. They have used the crisis in medicine quality in developing countries as an excuse to push for new intellectual property rules that will boost the profits of pharmaceutical giants at the expense of affordable medicines for the poor.”
ACTA and IMPACT among harmful initiatives
The European Union is especially culpable of pushing for stricter levels of IP protection that would limit access to medicines. In many cases, these efforts have been supported – both tacitly and overtly – by the multinational pharmaceutical industry.
The report highlights several of these harmful initiatives, including the Anti-Counterfeiting Trade Agreement, industry pressure to change intellectual property laws in Kenya and Thailand, and continuing negotiation of new anti-counterfeit measures at the World Health Organization through an initiative known as IMPACT.
Malpani said: “At a time when poor countries struggle to ensure that their populations can get affordable, quality medicines it is outrageous that rich countries and drug companies are pushing ‘solutions’ that will do more harm than good to patients and public health. It is critical that poor countries ignore rich-country pressure, and focus instead on solutions that will ensure both quality and affordability of medicines. While poor countries must continue to fight against efforts to introduce new intellectual property rules, they must also find ways to both invest in, and attract investments to create, well-functioning drug regulatory authorities.”
Notes to editors
- Substandard medicines
- Substandard medicines are medicines that do not meet quality standards or scientific specifications for the product as defined under World Health Organization guidelines. They may contain the wrong type or concentration of ingredient, or they may have deteriorated during distribution in the supply chain and thus become ineffective and dangerous.
- Falsified medicines
- Falsified medicines are medicines for which the identity, source or history of the product is misrepresented. Such products may be falsified, or fake, in terms of composition or ingredients, or they may be falsely labeled, meaning that the information provided about the product is inaccurate.
- Counterfeit medicines
- Counterfeit medicines are products that involve criminal trademark infringement. Only a subset of substandard and falsified medicines in developing-country markets is linked to criminal trademark infringement (counterfeiting). Therefore, new anti-counterfeit measures will do little to address the broader public health problem of substandard drugs.
Jon Slater: +44 (0)1865 472249 / +44 (0)7876 476403 / email@example.com