Quality & Compliance
Safety & Vigilance
29 september 2023
On 26th April 2023, the European Commission published its pharmaceuticals reform proposal for more accessible, affordable, and innovative medicines. The Commission proposes revising the European Union’s (EU) pharmaceutical legislation to make it more agile, flexible and adapted to the needs of citizens and businesses across the EU. It will support innovation and boost the competitiveness and attractiveness of the EU pharmaceutical industry while promoting higher environmental standards. In addition to this reform, the Commission proposes a Council Recommendation to step up the fight against antimicrobial resistance (AMR).
For continuous patient access, medications must be approved for marketing, and the company holding the authorization must place them on the market. The most innovative drugs receive centralized marketing authorization in the EU, allowing them to be simultaneously present in the markets of all member states. However, the decision to market a drug in a specific member state is the company’s business decision. It is based on market size, promotional and distribution networks, and national pricing and reimbursement policies. Therefore, small or less affluent member states often face limited or delayed entry of products into their markets.
To create a single market for medicines, the reform will move the current system away from its ‘one-size-fits-all’ regulatory protection towards a more effective incentives framework for innovation that promotes public health interests. As part of the proposed reform, the shortest period of regulatory protection for innovative drugs will be eight years, encompassing six years of data protection and two years of market protection. Companies can utilize additional periods of regulatory data protection if they market the drug in all member states (+2 years), develop a drug that addresses unmet medical needs (+6 months), or conduct comparative clinical trials (+6 months). Additional regulatory protection for marketing in all member states will be granted if the drug is continuously supplied in sufficient quantities to all member states within two years from the issuance of the marketing authorization or within three years if the company has limited experience within the EU system, for example, small and medium-sized enterprises (SMEs). Additional regulatory protection will be granted if a member state issues an exemption (for example, because it intends to introduce the drug later).
By implementing these measures, the earlier entry of generic and biosimilar drugs to the market will be facilitated, which will increase market competition among medications, prices will decrease, and cost-effective accessibility for patients and sustainability of healthcare systems will be promoted. Furthermore, the creation of comparative clinical data will be encouraged to enhance drug evaluation further and support pricing and reimbursement decision-making at lower levels. Reducing drug prices could also be aided by transparency in public funding. It’s often unclear how much public financial support has contributed to the research and development of a specific drug. Following the proposed reform, pharmaceutical companies will be required to disclose information about all direct financial support they have received from any public authority or publicly funded body for activities related to the research and development of medicines. This information will be readily accessible to the public on the company’s dedicated webpage and in a database of medicines for human use approved in the Union. Transparency is intended to assist member states in negotiations with pharmaceutical companies, ultimately leading to greater affordability of medications. Finally, to make medications more financially accessible, the pharmaceutical strategy for Europe has introduced measures to support collaboration among member states in pricing and reimbursement, which falls under national jurisdiction. Joint procurement of medicines can be a successful form of enhanced cooperation to increase affordability, access to medications, and supply security. This has been demonstrated through the joint procurement of therapeutics for COVID-19 and vaccines against monkeypox.
Last but not least, the scientific support provided by the EMA (European Medicines Agency) to drug developers before submitting marketing authorization applications will be enhanced. Currently, during the scientific evaluation of medicines for granting EU marketing authorization, there are significant interruptions where companies prepare responses to requests from the EMA for additional information missing from the initial submission. By enhancing scientific support, the quality of initial submissions will improve, delays caused by evaluation interruptions will be reduced, and the evaluation process for granting marketing authorization will be expedited. Incomplete submissions will be invalidated during the evaluation if the applicants fail to provide missing data within specified deadlines. This will free up resources and optimize the evaluation system.
Furthermore, as part of the reform, the duration of scientific assessments will be shortened from the current 210 days to 180 days, and the timeframe for the Commission to approve a drug will be reduced from 67 to 46 days. Assessments of medicines of significant public health interest will take 150 days. These shortened timelines and supportive measures will enable medicines to reach patients more quickly.
Drug shortages are becoming an increasingly significant issue for public health in many EU countries and globally. They represent a potentially severe risk to patient health within the EU and impact patients’ right to appropriate treatment. In recent years, the Parliament, through its resolutions, the Council, its conclusions, member states, and relevant stakeholders have highlighted the growing occurrence of drug shortages.
The proposed reform introduces requirements for continuously monitoring drug shortages by competent authorities at the national level and the EMA. The obligations of marketing authorization holders will be strengthened, including earlier and harmonized reporting of drug shortages and the implementation of plans to prevent shortages. In collaboration with the executive steering group for shortages and safety of medicines, EMA will have an enhanced role in coordinating continuous monitoring and management of critical drug shortages at the EU level. In this context, member states must report to EMA about all intended or undertaken measures at the national level to mitigate or address shortages of specific drugs. Transparency regarding shortages will be achieved by publishing information about drug shortages at national and EU levels.
The Commission will establish a list of crucial medicines at the EU level and conduct assessments of vulnerabilities in the supply chains of these medicines. Regarding critical shortages, marketing authorization holders will be required to address these shortages based on recommendations and report the outcomes of the measures taken. Examples of such suggestions could include increasing or reorganizing production capacities or adjusting distribution to enhance supply.
Special provisions will apply to medicines for rare diseases to encourage research and development in rare diseases. The standard duration of exclusive marketing rights for medicines for rare diseases will be nine years. Companies can utilize additional periods of exclusive marketing rights if they address significant unmet medical needs (+1 year), market the drug in all member states (+1 year), or develop new therapeutic indications for an already approved medicine for rare diseases (up to 2 additional years).
Through the proposed reform, the scientific support provided by the EMA will be further strengthened, particularly for promising drugs developed to address unmet medical needs, based on the experience gained from the Priority Medicines (PRIME) program. Such priority medicines will receive enhanced scientific and regulatory support and be subject to accelerated assessment mechanisms. This intensified PRIME program will encourage innovation in areas with unmet medical needs, allow pharmaceutical companies to expedite development, and promote earlier patient access to medications.
Antimicrobials are among the most essential medications. However, over the years, their excessive and improper use has led to increased AMR, meaning that antimicrobials are becoming ineffective, and infections are becoming more challenging or even impossible to treat. Antimicrobial resistance is a “silent pandemic” that causes more than 35,000 deaths annually in the EU and results in high costs for healthcare systems. Antimicrobial resistance is considered one of the EU’s three significant threats to health.
The EU needs both push incentives (research and innovation funding in antimicrobials, primarily through grants for research and within partnerships) and pull incentives (regulatory and financial) to encourage the successful development of effective antimicrobials and ensure access to them. The Commission proposes the following pull incentives: a temporary mechanism consisting of transferable data protection vouchers for the development of new antimicrobials, which will be issued and used under strict conditions; procurement mechanisms that ensure access to new and existing antimicrobials, guaranteeing revenue to marketing authorization holders for antimicrobials, regardless of sales volume.
Within the framework of the pharmaceutical legislation reform, measures for rational use will become part of the marketing authorization process, encompassing the way a medication is issued, appropriate package sizes, unique patient/healthcare information, an antimicrobial management plan, including risk mitigation measures, and monitoring of resistance to the specific antimicrobial and reporting on it. The Council’s recommendation proposal suggests additional support measures, including goals and actions to promote high infection prevention and control, enhancing information, training, and education, and fostering collaboration among stakeholders from all relevant sectors.
Scientific evidence indicates that drugs enter the environment due to production, patient use, and improper disposal of unused or expired medications. Of particular concern is that antimicrobials have been detected in wastewater treatment, wastewater generated during production, surface waters, and groundwater, as their presence contributes to AMR. Medications in the environment not only impact the ecosystem, but if they enter the water cycle or the food chain, they can directly affect human health.
The proposed reform of pharmaceutical legislation responds to several commitments outlined in the strategic approach to pharmaceuticals in the environment. It strengthens the assessment of the environmental risks posed by medications to ensure better evaluation and limit potential adverse effects of drugs on the environment and public health. Environmental risk assessment is now mandatory for all pharmaceutical companies placing their drugs on the EU market, encompassing the use and disposal of medications into the environment. Furthermore, efforts to promote EU environmental standards at the international level will continue.
The Parliament and the Council will now discuss the proposal. The discussions will start as soon as possible, but the timing for adoption at this stage cannot be predicted.
The Commission said its package of measures would help increase patient access to medicines and deliver hundreds of millions of euros of annual savings to public health systems in the EU. It said pharmaceutical companies would also realize savings from the more streamlined regulatory processes. However, it has also assessed that while its specific proposals concerning orphan medicines will boost the gross profits of generic manufacturers, there would be an annual estimated fall in the gross profits of originator manufacturers of €640 million arising from those plans – though it said they stand to gain an estimated €103 million each year in gross profits from the proposals specific to pediatric medicines.
We can see the European Commission is pushing for several changes. Whether they all come to the past or not, it shows a trend in the industry. Change is ever-present, and we must stay lean and flexible to adapt to minor and major changes. PLG’s core concepts revolve around this adaptability, one of the main advantages we can bring to our clients. It is change management. We support by identifying the main reason for change and the main factors facilitating changes, and we implement plans around these factors to allow you and your to change and grow as the industry does.
PLG has our experts to support you in registration, commercialization, life cycle maintenance, price and reimbursement, and general innovation. Contact us to learn how partnering with us can drive your company forward.
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