The proliferation of substandard, dangerous medicines in poor countries is being used by rich nations as an excuse to tighten intellectual property (IP) rules, boosting the profits of large pharmaceutical companies while making it harder for poor people to get access to the medicines they need, claims a new report.

The study, which is produced by international aid agency Oxfam, is particularly critical of the European Union (EU) for “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,” it claims.

Improved regulation of medicines by poor countries, rather than enforcement of IP rules, is the best way to ensure the supply of safe, effective and quality medicines, claims the study, which is entitled Eye on the Ball and was launched at a conference in Paris last week hosted by INTERPOL and the World Intellectual Property Organization (WIPO) in Paris.

Over two billion worldwide people lack regular access to affordable and quality medicines and the World Health Organization (WHO) estimates that 30% 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% of certain types of medicines, such as anti-malarials, are substandard, says Oxfam.

Rich countries express concern about this threat to public health but the actions they propose will do little to address this problem, according to Oxfam, which points specifically to calls from wealthy nations for poor countries to enact expanded IP rules to reduce the availability of counterfeit products that criminally infringe trademarks. But, the report argues, 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 IP rights. And worse, new anti-counterfeit measures will stifle the production of and trade in low-cost generic medicines, it adds.

The report urges rich countries to abandon their focus on expanded IP protection and instead provide funds to support drug regulation in poor countries.

“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,” said Rohit Malpani, senior policy adviser at Oxfam.

“The European Union (EU) 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 IP rules that will boost the profits of pharmaceutical giants at the expense of affordable medicines for the poor,” he added.

The study is particularly critical of the EU for its support for “harmful initiatives” to tighten levels of IP protection and limit access to medicines, adding these are, in many cases, backed by the multinational pharmaceutical industry.

These initiatives include the Anti-Counterfeiting Trade Agreement (ACTA), industry pressure to change intellectual property laws in Kenya and Thailand and continuing negotiation of new anti-counterfeit measures at the WHO through the International Medical Products Anti-Counterfeiting Taskforce (IMPACT) initiative. This latter initiative should be disbanded, said Oxfam.

The report also recommends that governments of developing countries should promote generic competition in their drugs policies and invest in both their regulatory authorities’ capacity and the provision of free essential medicines.

For their part, pharmaceutical companies should adhere consistently to WHO quality standards and “fulfill their responsibility to declare to purchasers the full provenance of products openly and transparently,” the report recommends.

Moreover, drugmakers should “recognize the damage inflicted on public as a result of the confusion of quality with IP issues in initiatives such as IMPACT, and correct this fundamental error in their public statements and comments,” says Oxfam.