The European Commission was expected to outline proposed amendments to the Human Medicines Directive and Regulation by the end of this year, but Politico has reported that an impact assessment on the planned changes has been rejected by the Regulatory Scrutiny Board within the European Commission.
The Regulatory Scrutiny Board acts as quality control over major EU legislative initiatives. Impact assessments for such initiatives need to be endorsed by the Board for the Commission to be able to take forward the plans. Where it issues a negative opinion, “the draft report must be reviewed and resubmitted to the Board before it can proceed”, according to its website.
The EU’s general pharmaceutical legislation was the subject of a review by EU policymakers following publication of the European Commission’s pharmaceutical strategy in November 2020. The Commission said at the time that the aim of the review was to “ensure a future-proof and crisis-resistant medicines regulatory system”.
In its review, the Commission said it was 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.
The anticipated proposals in relation to amendments to human medicines legislation only form part of a wider package of reforms expected to stem from the review, according to life sciences expert Jules Fabre of Pinsent Masons.
Fabre said: “The evaluation in relation to human medicines law is running in parallel to a number of other initiatives from the European Commission in relation to specific areas of the pharmaceutical legislation, such as the review of orphan and paediatric regulations, the review of the supplementary protection certificate (SPC) regulation and potential introduction of a unitary SPC and/or unified SPC grant mechanism, a public consultation on compulsory licensing. All of this will likely lead to quite significant changes to the pharmaceutical legal and regulatory framework in Europe by 2023-2024, in particular when it comes to incentives to invest in new medicines and medical technologies.”
Catherine Drew, also of Pinsent Masons, who specialises in regulation in the life sciences sector, said the Commission should take longer to get its reform package right, rather than push through a proposal which doesn’t meet the goals it has identified for reform. She said industry and ultimately patients would pay the price of navigating proposals that are not right.
“There may be a perception that the pharmaceutical regulatory framework requires some updating to take account of progress, such as the efficiencies in regulatory process driven by the Covid-19 pandemic and more broadly in opportunities offered through digital technology and data,” Drew said. “However, industry would no doubt prefer that the Commission takes longer and presents a proposal which is balanced, efficient and effective. This would be preferable than proposals being rushed through but resulting in a new regulatory framework which introduces greater challenges that industry is left to navigate.”
Politico reported that it is now possible that the proposals on human medicines expected before the end of 2022 will not now be published by the Commission until into 2023.
Once the Commission has adopted legislative proposals, they face scrutiny by the EU’s two main law-making bodies – the European Parliament and the Council of Ministers. It is common for both bodies to make amendments to the Commission’s original text before entering so-called ‘trilogue’ negotiations with a view to agreeing on finalised wording. Both bodies must formally adopt the text before the proposals can become EU law.
The process of making new EU legislation, particularly in areas as important and complex as pharmaceuticals, can take several months and even years. Public policy expert Mark Ferguson of Pinsent Masons said that if the Commission’s proposals are delayed, this is likely to have an impact on when the final proposals are agreed.
“This delay could mean that there is insufficient time pre-European Parliament elections in 2024 to complete negotiations and reach an agreement once the reforms are presented by the Commission,” Ferguson said. “Therefore, it could be after the 2024 elections before the reforms are progressed fully in Parliament.”