The European Commission is collecting comment on its multifaceted blueprint for broadening access to biologics and generic drugs and stimulating competition.
The autumn months have opened with a public comment phase in the European Union’s ambitious blueprint for improving affordability and access to medicine, including biosimilars. The plan tackles patent exclusivities, standardizes pharmaceutical policies across multiple markets, and encourages the use of off-patent medicines in areas of unmet need.
“The strategy is an ambitious, long-term project in the area of health. It is intended to make the European pharmaceutical system patient-centered, future-proof, and crisis-resistant,” according to the European Commission.
“The Commission will consider targeted policies that support greater generic and biosimilar competition, based on the sound functioning of the single market, appropriate market protection mechanisms, the removal of barriers that delay their timely entry to market and increased uptake by health systems,” the plan states.
Broadening the "Bolar" Provision
The proposal calls for possibly broadening the “Bolar” provision, which exempts biosimilar development companies from infringing on originator company patents when using products for the purpose of studies and trials in preparation for seeking marketing authorization.
Bolar is not applied consistently across markets. For example, some may allow use of patented drug products to clinical studies necessary only for marketing authorization, whereas other may allow greater freedoms of use, according to a legal review of the proposed changes by Jules Fabre, of Pinsent Masons.
“This fragmentation means clinical trials and studies may or may not fall into the scope of the exemption depending on where they are carried out,” he stated.
Another potential outcome of the commission’s review is a greater emphasis on substitution of biosimilars for originator products. “Certain conditions such as newly launched niche products for a small number of patients or the absence of automatic substitution rules for biologicals, can create market barriers. This means that competing generics, biosimilars and ‘older’ products may find it hard to enter or stay in the market,” the commission wrote in its blueprint.
The commission hopes that ultimately, its review of pharmaceutical legislation will lead to more competition and lower prices.
Also on the drafting table, according to Pinsent Masons, is a potential exclusivity period for biosimilars that would grant them preferred status when they first come to market.
The commission is hoping to break the headlock that traditional factors have on the dissemination of biosimilars and other drug agents. Pricing and reimbursement policies, wealthier markets, and national administrative policies all influence manufacturer decisions on where to market drugs. The commission aims to achieve a more even distribution of essential medicines by sculpting a more “patient-centric” marketplace.
An effort to review potential anticompetitive practices and implement safeguards is incorporated into the plan.
“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. The commission will also continue to carefully review mergers between pharmaceutical companies to avoid distortion of competition,” the commission report states.
Additionally, the commission hopes to allow earlier market launch for biosimilar and generic developers when originator companies fail to roll out their products across markets soon enough, according to Pinsent Masons.
Comments From Both Sides of the Atlantic
The public comment period continues through the close of 2021. Already, the window of opportunity has attracted comments from both sides of the Atlantic.
The US Chamber of Commerce has protested the possible weakening of existing protections for originator pharmaceutical companies, contending these may lead to reduced investment and innovation and deprive the public of next-generation medicines.
“To avoid undermining innovation incentives, extreme caution should be taken to ensure that amendments to [intellectual property rights] for competition policy purposes (such as in relation to ‘Bolar’ exemption) strictly adhere to the end goal…, to facilitate clinical testing limited to purposes of generating safety and efficacy data for regulatory purposes,” the chamber wrote.
Pharmaceutical Research and Manufacturers of America (PhRMA), a trade association, addressed concerns expressed by the commission about uneven access to medicines across the European Union. “The EU pharmaceutical legislation will not solve the barriers to faster patient access. Moreover, conditioning incentives on access could undermine the goal of improving access to medicines in the EU and undermine their development in the first place,” the group wrote.
The TEDDY European Network of Excellence for Pediatric Research, in a response to the commission plan, called for more attention paid to developing or providing medicines for use in children.
COVID-19 shortages have hurt access to important medicines, “However, in [the] case of children the situation has proven to be more and more challenging, due to the chronic shortage of appropriate treatments, even when the treatment exists but has been tested and produced for adults use. Moreover, medicines are often not available in a pharmaceutical form suitable for all the children’s age groups,” the group wrote.