USTR complains of IP infringements in pharma sector
Particular concern with proliferation of counterfeit pharmaceuticals manufactured sold, and distributed in trading partners such as Brazil, China, Guatemala, India, Indonesia, Lebanon, Peru, and Russia
The United States Trade Representative (USTR) has highlighted its continuing concern about intellectual property rights violations in the pharma sector, citing claims that 20% of medicines sold in India are fakes.
In its annual ‘Special 301 Report’, the USTR said it notes 'its particular concern with the proliferation of counterfeit pharmaceuticals that are manufactured, sold, and distributed in trading partners such as Brazil, China, Guatemala, India, Indonesia, Lebanon, Peru, and Russia.' The large-scale reported sale of counterfeit medicines in India 'could represent a serious threat to patient health and safety,' said the report.
Indeed, the report stressed that the Indian pharmaceutical industry 'faces a host of challenges related to IPR'. These include irregularities in applying the Patents Act; an ineffective system for protecting against unfair commercial use and unauthorised disclosure of undisclosed medical trial test data; a lack of clarity on standards for compulsory licences; and inefficient alerts regarding marketing approvals for generics.
'Brand owners also face delays and challenges in obtaining trademarks, and rampant counterfeit products in the market. India has yet to develop legislation that would ensure trade secrets are adequately protected against misappropriation,' it added.
The Indian pharmaceutical industry faces a host of challenges related to IPR, the report said
The report noted that 97% of all counterfeit pharmaceuticals seized at the US border in the 2015 fiscal year were shipped from China, Hong Kong, India, and Singapore.
It also cited concerns within the US pharmaceutical and medical device industry about the pharma innovation and market access policies of Algeria, Austria, Belgium, China, Colombia, Czech Republic, Ecuador, Hungary, Italy, South Korea, Lithuania, New Zealand, Portugal, Romania, Taiwan, and Turkey.
Problems highlighted in the report included Algeria’s ban on more than 350 imported pharmaceutical products and medical devices.
Regarding European Union member states Austria, Belgium, Czech Republic, Finland, Hungary, Italy, Lithuania, Portugal, and Romania, the USTR is concerned about 'uncertainty and unpredictability' in pharma pricing and reimbursement policies.
There has been progress, however. The USTR removed Tajikistan from its IP Watch List after it passed legal reforms protecting against the unfair commercial use and unauthorised disclosure of undisclosed pharma test or other data.
The USTR welcomed reports that in 2015, customs authorities in Hong Kong increased their efforts to seize counterfeit pharmaceuticals, and that US Customs and Border Protection (CBP) collaborated with Singapore Customs in fighting counterfeit pharmaceuticals.
