New EU laws safeguarding national ownership of ‘genetic resources’ may delay production of seasonal influenza vaccines according to EFPIA, which wants stakeholders to discuss the issue.
Last week the European Parliament adopted laws designed to ensure that natural genetic resources are accessed in a responsible way and that any benefits coming from their commercial use are shared fairly.
Viruses are classed as a genetic resource under the legislation, which means that any company using them to develop a vaccine must first obtain prior informed consent from the source country.
While the laws are unlikely to impact production of most anti-infectives, they could hinder manufacturers of seasonal influenza vaccines which must collect circulating virus strains every year, according to the European Federation of Pharmaceutical Industry Associations (EFPIA).
“For every new influenza season, there are three or four different virus strains selected by the WHO expert groups; this is done twice per year, in view of isolating the virus and preparing the seed strain to be provided to vaccine manufacturers to produce the vaccine.”
EFPIA told in-Pharmatechnologist.com that new strains and reagents are usually made available to manufacturers by March to April in order to have vaccines available by August to September of the same year to start the Northern hemisphere influenza campaign.
The organization is concerned that any delays to these already tight production timelines resulting from lengthly negotiations with source countries could negatively impact manufacturers’ ability to produce vaccines.
“In light of this, we consider that all relevant stakeholders should sit together and find practical solutions to not only ensure compliance with the new regulation, but also to allow seasonal vaccines to be developed in time for the vaccination campaign.”
The European Parliament did not respond to a request for comment.
Despite the concerns relating to influenza vaccine, EFPIA backed the adoption of both the new laws and the Nagoya Protocol , which is the agreement that underpins the Convention on Biological Diversity (CBD).
The industry group’s only caveat is that they are implemented with industry in mind.
“Most large pharmaceutical companies have closed their active natural products programmes over the past 10 years. Today, natural product discovery is found largely in smaller discovery companies, semi-governmental or governmental entities and universities around the world.
“However, as potential downstream users of their results, it was important to ensure the implementation of the Nagoya Protocol in the EU would ensure legal certainty for all users, and would foster collaborations involving academia and large and small companies.