The European Commission’s formal pitch for revising the medicines legislative & EU regulatory framework was recently released. The new European regulatory documents targeting pharmaceutical industry reform & regulation law have been uploaded to the EU’s website. Multiple documents are included to help industry participants better understand the proposed regulatory compliance initiatives.
Regulatory Framework
The current European regulatory system is responsible for the evaluation & assessment of medicinal products. This regulatory process involves the European Medicines Agency (EMA), the competent authority of each EU member state, and subject matter experts on EMA scientific committees.
The proposed measures are designed to update the regulatory framework to accommodate the increase in EU pharmaceutical new product development. This includes requirements related to both clinical trials & real-world evidence. Additionally, secondary use of health data & regulatory sandboxes are also a focus of the legislation.
Regulatory Legislation
The new legislation draft mentions COVID-19 & the reduced availability of scientific resources has led to capacity constraints becoming more common. Further, this problem would continue without changes based on the current regulatory submission volume from drug companies.
Finally, the proposal mentions the current inefficiency of pharmaceutical product submissions. Regulatory submissions currently going through as many as five scientific committees to receive marketing authorization. A simplified regulatory framework is proposed to add flexibility so committee members have more time to concentrate on evolving pharmaceutical drug priorities.
Scientific Committees
The regulatory legislation draft proposes to reduce the number of scientific committees to just two:
- Committee for Medicinal Products for Human Use (CHMP)
- Pharmacovigilance Risk Assessment Committee (PRAC)
The CHMP & PRAC would continue to include pharmaceutical chemistry subject matter experts from each EU member state. The CHMP would also incorporate patient representatives on the new committee, a first of its kind for the European Commission. This representation of patients & health care professionals would consist of individuals with expertise in all areas, including rare & pediatric diseases.
Regulatory Training
New members of scientific committees from all EU member states would be offered different types of regulatory training opportunities. The goal for the EU regulatory training is to increase expertise in new areas of science & technology by partnering with top pharmaceutical companies & industry experts. This would help to relieve the current bandwidth issues many regulatory agencies & committees encounter, directly impacting new committee members who can contribute.
Further, training programs would be designed to help individuals assess & monitor pharmaceutical products. In fact, the proposal specifically mentions the speed of researching & approving cutting edge medicinal products from drug manufacturers.
Regulatory Procedure
The regulatory proposal continues by documenting the need for a reduction of regulatory burden on the committees. The opportunity to simplify regulatory procedures & increased digitalization are both mentioned as European Medicines Agency priorities. Additionally, this regulation meaning could influence electronic submission of applications & electronic product information (ePI) for approved pharmaceuticals.
Sunset Clause
Two measures designed to shrink the EU regulatory committee responsibility are the elimination of the renewal and the sunset clause. The EMA legal framework states the pharmaceutical research leading to marketing authorization of a medicine will:
- Cease to be valid if the medicine is not on the market within three years of approval
- Cease to be valid if the medicine is removed from the market for three consecutive years
While this does not represent a majority of pharmaceutical regulatory approvals, it does show the goal of the proposal is simplification. By reducing the regulatory burden of unnecessary policy, pharmaceutical companies should hopefully be able to expedite their dealings with the EMA. This will also amplify the streamlining of the new scientific committee structure. Finally, a more efficient regulatory process should help new pharmaceuticals move toward approval quicker and deliver product to patients sooner.
Paediatric Investigation Plans (PIPs)
Paediatric drug development is also evolving per the regulatory proposal draft. Clinical development plans for children at a young age currently requires pharmaceutical manufacturers to make statements about the anticipated results. As a result, regulatory teams submitting approval for novel therapies will be given more freedom to introduce a high level clinical development plan. Subsequently, this could help pharma manufacturing companies working on multiple novel treatments at the same time during the pharmaceutical product development process.
Pharmaceutical Companies
So, who exactly does this proposed legislation help & would it impact pharmaceutical sales? According to the EMA, the reduction of administrative burden should benefit small & medium-sized EU pharmaceutical companies who have more challenges bringing new products to market. The regulatory legislation would also help not-for-profit bodies participating in pharmaceutical manufacturing research & development of new therapeutic products.
Industry Reaction
As anticipated, reaction from big pharma leaders has been swift & mixed. Martuscelli reports that policymakers want to tackle the uneven rollout of drugs across the EU. However, the proposed rules would remove two years of data protection from all new medicines launched in the European Union.
This would allow unbranded competitors to enter the market more quickly. Cutting drug market exclusivity for new medicines from ten to eight years will not go over well with pharmaceutical industry executives. Billions of dollars are spent annually on pharmaceutical technology & developing new products to address unmet needs of the patient.
Stella Kyriakides, European Commissioner for Health and Food Safety, commented the proposal would help regulatory process by offering incentives for novel drugs & providing concrete action toward reducing drug shortages. Additionally, transparent supply chains & leaner regulatory approval rules could increase the speed of pharmaceutical science programs. This is an important step as pharmaceutical supply chain members recover from the COVID-19 pandemic & drug shortages associated with the outbreak.
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