Tony Hagen is senior managing editor for The Center for Biosimilars®.
The European Commission (EC) said it will take the lessons learned from the coronavirus disease 2019 (COVID-19) pandemic and build a better marketplace for generics and biosimilars.
The European Commission (EC), the group that authorizes medicines for the European Union, has issued a blueprint for emerging from the coronavirus disease 2019 (COVID-19) pandemic with a stronger, more competitive health care industry that is more supportive of the uptake of biosimilars and generics.
The EC “pharmastrategy” issued this week outlines a myriad of goals, such as achieving a more competitive system that does not discourage innovation or turn biosimilar and generic producers away, developing a deeper understanding of pharmaceutical supply chain issues so that uncertainties spawned by the pandemic can be managed more effectively the next time, and improving country-by-country procurement of medicines by strengthening the competitive bidding system.
“Though we are experiencing a period of rapid change and innovation, many patients do not benefit from that innovation, because medicines are either unaffordable or unavailable. And there is greater awareness of the need to ensure that our use of pharmaceuticals is sustainable,” the EC said.
The blueprint also calls for stepping up efforts to develop new antimicrobials and antibiotics (a subclass of antimicrobials) and impose regulations that encourage more safe and sensible use of these medicines. This will include greater use of existing regulatory tools to combat growing resistance to these medicines.
In response to the statement, Medicines for Europe, a trade association of pharmaceutical manufacturers, called upon the EC to work especially hard to develop a marketplace that promotes access to biosimilars, generics, and other “value-added” drugs.
“Often in Europe, patients can only fully access the medicines they need when the off-patent version becomes available. Barriers to off-patent medicines use must be removed,” the group said in a statement.
Vulnerabilities in Sharp Focus
COVID-19 has had “a very serious impact on Europe,” and although the European Union’s strengths in responding have been showcased during the pandemic, its vulnerabilities have been “thrown into sharp focus,” the EC said. There have been problems with data availability, medicine supply, and manufacturing capacity.
“The conclusion of advance purchase agreements for vaccines is nevertheless an example of effective cooperation between public and regulatory authorities, industry, and civil society organizations,” the EC said.
But because of access bottlenecks in various markets, innovative therapies do not always reach patients, the EC said. “Companies are not obliged to market a medicine in all EU countries.”
This might happen because of national pricing and payment policy, population size, health system organization, or relative wealth factors country by country, the EC suggested. The blueprint included recognition of a critical lack of transparency on research costs and necessary return on investment, which each factor into a company's decision to enter or refrain from entering a market.
“Drawing on this and wider experience, the commission will review the system of incentives,” the EC said.
In tandem with this, the EC said it will consider “targeted policies” for beefing up generic and biosimilar competition. “This may include further clarifying the provisions for the conduct of trials on patented products to support generic and biosimilar marketing authorization applications.”
The EC said it intends to buttress these efforts with “enforcement” of rules on competition, noting that “originator companies sometimes implement strategies to hinder the entry or expansion of the more affordable medicines of their generic and biosimilar competitors and that such strategies may require competition law scrutiny.”
Reforming the competitive landscape is not a one-way street, the EC said. It called upon health systems and private companies to make use of an “innovation partnership” tender system that allows for cooperative agreements on development, manufacturing, and subsequent purchase of medicines.
“Certain conditions…such as the absence of automatic substitution rules for biologicals, can create market barriers,” the EC said. “This lack of competition thus inhibits price savings once innovative products lose their market exclusivities. The commission will take this into account in the review of the pharmaceutical legislation, to see how sound competition can best be fostered, leading to a downward effect on prices of medicines.”
In a recent white paper, Medicines for Europe described numerous intellectual property hurdles that constitute barriers to entry for biosimilars and generics. To read the story, click here.