In its statement, ESIP, representing public payers, warmly welcomes the Commission’s proposal to amend the Regulation by introducing a manufacturing waiver for EU-based generic and biosimilar producers for export purposes. “The proposal has the potential to increase competition in the sector and encourage generic and biosimilar manufacturers to establish facilities in the EU. More importantly, improved competition will lead to more affordable medicines and to a wider choice of products for patients. This is in line with the public payers’ mission to ensure access to high quality healthcare for all, in an affordable way”, stresses Arnaud Emériau, ESIP’s President.

Nevertheless, in ESIP’s view the Commission’s text should go further to address public health interests by introducing an additional stockpiling waiver that would allow generic and biosimilar manufacturers to launch their products immediately on day-1 after expiry of the SPC - without further delay.

In addition, ESIP believes that the interests of patients and healthcare systems would be best met by introducing these waivers as soon as possible, i.e. also to existing SPCs recalling that the aim of the new rules is to resolve unintended consequences of the current Regulation on general interest and public health. It cannot therefore be reasonably argued that immediate application of the new rules to existing SPCs would deprive the originator companies of their due rights.

“We should not have to wait another 10-15 years for patients and healthcare systems to benefit from the waivers. Patients’ access to affordable treatment cannot wait!”, says Arnaud Emériau.

Find out more in our statement.