The European Commission has begun a public consultation on potential reforms to EU general pharmaceutical law.
The review of the EU’s general pharmaceutical legislation is a core plank of the European Commission’s pharmaceutical strategy, published in November 2020. The Commission said the aim of the review is to “ensure a future-proof and crisis-resistant medicines regulatory system”.
In its review, the Commission is considering potential reform in a wide range of areas including in relation to unmet medical needs; improving access to and affordability of medicines; addressing antimicrobial resistance, ensuring security of supply of medicines, adapting the regulatory approach to account for “novel products”; and environmental challenges.
Notably, EU policymakers are considering how to stimulate innovation in areas of unmet medical needs and whether the existing incentives framework is fit for purpose. The consultation seeks views on potential changes to the current regulatory data and market exclusivities which innovators enjoy upon getting regulatory approval for new speciality medicines. The proposed options include introducing new conditions to existing incentives - such as a commitment to make the medicine available in all EU member states - granting longer periods of protection in areas of unmet medical needs, or introducing new types of incentives in these areas.
A “transferable exclusivity voucher” is one of the possible new incentives the European Commission is considering to address antimicrobial resistance. Such vouchers are additional periods of exclusivity that would be granted to innovators upon regulatory approval of a new antibiotic. Subject to certain conditions, the vouchers could be used by the innovators to extend the protection of any other medicine in their own portfolio or transferred or sold to a third-party.
The Commission has also asked for feedback on potential measures that could be introduced to improve access to, and affordability of, medicines. It acknowledged the role that generic and biosimilar medicines have in this regard.
One of the options for supporting access to affordable medicines the Commission has proposed is a broadening of the so-called ’Bolar exemption’, which exempts from patent infringement the conduct of certain studies and trials for the purpose of applying for marketing authorisations.
Life sciences expert Jules Fabre of Pinsent Masons, the law firm behind Out-Law, said that, to date, EU countries have adopted different approaches when implementing this exemption.
“Some have applied the exemption with the minimum standard of the 2001 Medicinal Products for Human Use Directive, which limits its scope to studies that are ’necessary‘ to obtain a marketing authorisation in the EU or EEA for a generic, hybrid of biosimilar medicine; while other member states have adopted a broader exemption,” he said. “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, and the Commission seeks to tackle this issue.”
The Commission is also considering the creation of a specific regulatory incentive, potentially an exclusivity period, for a limited number of biosimilars that come to the market first. It is also considering introducing “an EU-wide scientific recommendation” in order to address the lack of harmonisation at a EU level on rules applying to interchangeability and substitution of biosimilars. This would encourage doctors to switch patients from using originator products, that sometimes attract a higher price, to approved rival medicines that are biologically equivalent, or to substitute a prescribed reference product for its biosimilars at pharmacy level.
The Commission is also considering new measures to encourage pharmaceutical manufacturers that have been granted EU-wide marketing authorisations via the centralised procedure to market those products in every EU member state. It said “various factors, such as national pricing and reimbursement policies, size of the population and level of wealth, the organisation of health systems and national administrative procedures” sometimes influence manufacturers in their decision to launch or not in certain national markets within the EU.
To improve patient access to medicines across the EU, the Commission is considering a range of measures, including a requirement for companies to notify their market launch intentions upon receiving a marketing authorisation. It is also proposing providing “incentives for swift market launch across the EU” or allowing generic or biosimilar medicines to enter the market early in cases where there is delayed launch of originator medicines across the trading bloc, subject to patent rights.
More radical options consulted on include requiring companies to place their approved medicines on “the market of the majority of member states, that includes small markets” within a certain period following approval or requiring them to offer company the option of supplying their medicines to a market they withdraw from.
The Commission has also asked for views on what measures “could stimulate the repurposing of off-patent medicines and provide additional uses of the medicine against new diseases and medical conditions”, and it is further considering introducing new requirements on pharmaceutical companies to guard against a potential shortage of supplies in the EU in future. In addition to potentially introducing new reporting and stockpiling obligations, the Commission is considering requiring companies to diversify their supply chains.
Potential harmonisation of environmental risk assessments across the EU relevant to medicines for human use is also under consideration.
The Commission’s consultation runs until 21 December. The Commission aims at adopting a proposal for a regulation by the end of 2022. A separate review of EU legislation for medicines for rare diseases and children is ongoing. A consultation on that subject closed earlier this year.
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