New trades secret law could block clinical trial information exchange, claims EPHA

The European Public Health Alliance (EPHA) has raised concerns that a new proposed European Union (EU) directive on trade secrets will undermine recently introduced rights to explore EU clinical trial data.

The EPHA was commenting after the European Parliament approved the new legislation (on 14 April), which introduces an EU-wide definition of ‘trade secret’ and obliges EU member states to ensure that victims of misuse of trade secrets can defend their rights in court and to seek compensation. The agreed law also lays down rules to protect confidential information during legal proceedings. The EU Council of Ministers was expected to formally approve the legislation on 26 May.

While a European Parliament communiqué claimed that amendments it supported will ensure the legislation 'does not curb media freedom and pluralism or restrict the work of journalists, in particular with regard to their investigations and the protection of their sources,' the EPHA fears that the law could be used by pharmaceutical firms to restrict access to clinical trial data authorised under the EU clinical trials regulation.

EPHA Secretary General Nina Renshaw argued that the vote 'is clearly designed to undermine' this earlier law 'on which the ink is barely dry, which was huge progress for patient safety and access to medicines, but has always been opposed by the pharmaceutical industry which prefers to conduct trials in secrecy.'

She argued that the law could smooth negotiations between the EU and the US for forging a Transatlantic Trade & Investment Partnership (TTIP) trade deal including these 'lower transparency requirements in the EU' which would henceforth be 'closer in line with much weaker rules in the US'.