MEPs adopted their proposals to revamp EU pharmaceutical legislation, to foster innovation and enhance the security of supply, accessibility and affordability of medicines. The legislative package, covering medicinal products for human use, consists of a new directive and regulation.
MEPs want to introduce a minimum regulatory data protection period (during which other companies cannot access product data) of seven and a half years, in addition to two years of market protection (during which generic, hybrid or biosimilar products cannot be sold), following a marketing authorisation.
Pharmaceutical companies would be eligible for additional periods of data protection if their particular product addresses an unmet medical need (+12 months), if comparative clinical trials are being conducted on the product (+6 months), and if a significant share of the product’s research and development takes place in the EU and at least partly in collaboration with EU research entities (+6 months). MEPs also want a cap on the combined data protection period of eight and a half years.
A one-time extension (+12 months) of the two-year market protection period could be granted if the company obtains marketing authorisation for an additional therapeutic indication which provides significant clinical benefits in comparison with existing therapies. Orphan drugs (medicines developed to treat rare diseases) would benefit from up to 11 years of market exclusivity if they address a “high unmet medical need”.
To boost research and the development of novel antimicrobials, MEPs want to introduce market entry rewards and milestone payment reward schemes (e.g. early-stage financial support when certain R&D objectives are achieved prior to market approval). These would be complemented by a subscription model scheme through voluntary joint procurement agreements, to encourage investment in antimicrobials.
They support the introduction of a “transferable data exclusivity voucher” for priority antimicrobials, providing for a maximum of 12 additional months of data protection for an authorised product. The voucher could not be used for a product that has already benefited from maximum regulatory data protection and would be transferable only once to another marketing authorisation holder.
The Commission is proposing to revise the EU’s pharmaceutical legislation – the largest reform in over 20 years – to make it more agile, flexible, and adapted to the needs of citizens and businesses across the EU. The revision will make medicines more available, accessible and affordable. 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).
The challenges this reform addresses are fundamental. Medicines authorised in the EU are still not reaching patients quickly enough and are not equally accessible in all Member States. There are significant gaps in addressing unmet medical needs, rare diseases and antimicrobial resistance (AMR). High prices for innovative treatments and shortages of medicines remain an important concern for patients and healthcare systems. In addition, to ensure that the EU remains an attractive place for investment and a world leader in the development of medicines, it needs to adapt its rules to the digital transformation and new technologies, whilst cutting red tape and simplifying procedures. Finally, the new rules need to address the environmental impact of medicine production in line with the objectives of the European Green Deal.
The revision includes proposals for a new Directive and a new Regulation, which revise and replace the existing pharmaceutical legislation, including the legislation on medicines for children and for rare diseases. It aims to achieve the following main objectives:
- Create a Single Market for medicines ensuring that all patients across the EU have timely and equitable access to safe, effective, and affordable medicines;
- Continue to offer an attractive and innovation-friendly framework for research, development, and production of medicines in Europe;
- Reduce drastically the administrative burden by speeding up procedures significantly, reducing authorisation times for medicines, so they reach patients faster;
- Enhance availability and ensure medicines can always be supplied to patients, regardless of where they live in the EU;
- Address antimicrobial resistance (AMR) and the presence of pharmaceuticals in the environment through a One Health approach;
- Make medicines more environmentally sustainable.
Key elements of the proposal:
- Better access to innovative and affordable medicines for patients and national health systems: new incentives will encourage companies to make their medicines available to patients in all EU countries and develop products that address unmet medical needs. Furthermore, earlier availability of generic and biosimilar medicines will be facilitated, and market authorisation procedures simplified. Measures for greater transparency of public funding of medicines development will be introduced and the generation of comparative clinical data will be incentivised.
- Promoting innovation and competitiveness through an efficient and simplified regulatory framework: the reform will create an innovation-friendly regulatory environment for the development of new medicines and the repurposing of existing ones. The European Medicines Agency (EMA) will provide better early regulatory and scientific support for developers of promising medicines to facilitate the fast approval and help SMEs and non-profit developers. The scientific evaluation and authorisation of medicines will be sped up (e.g., EMA authorisation procedures will take 180 days, helping reduce the current average of around 400 days) and the regulatory burden will be reduced through simplified procedures (e.g., by abolishing in most cases marketing authorisation renewal and introducing simpler procedures for generic medicines) and digitisation (e.g., electronic submissions of applications and electronic product information). The highest quality, safety, and efficacy standards for the authorisation of medicines will be maintained.
- Effective incentives for innovation: regulatory protection of up to a maximum of 12 years for innovative medicines, combined with the existing intellectual property rights, will ensure Europe remains an attractive hub for investment and innovation. 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 also promotes public health interests. To achieve this, it proposes a minimum period of regulatory protection of 8 years that can be extended in the following cases: if medicines are launched in all Member States, if they address unmet medical needs, if comparative clinical trials are conducted, or if a new therapeutic indication is developed. The combination of the existing intellectual property rights and the new regulatory protection periods will also safeguard the EU’s competitive edge in pharmaceutical development, one of the most protective world-wide. The reform will drive efforts so that research and development will focus on the patients’ greatest needs and there is more timely and equitable patient access to medicines across the EU.
- Addressing shortages of medicines and ensuring security of supply: the reform introduces new requirements for monitoring of shortages of medicines by national authorities and EMA and a stronger coordination role for EMA. Obligations on companies will be strengthened, including earlier reporting of shortages and withdrawals of medicines and development and maintenance of shortage prevention plans. An EU-wide list of critical medicines will be established, and supply chain vulnerabilities of these medicines will be assessed, with specific recommendations on measures to be taken by companies and other supply chain stakeholders. In addition, the Commission can adopt legally binding measures to strengthen security of supply of specific critical medicines.
- Stronger protection of the environment: better enforcement of current environmental requirements will limit the potential negative consequences of medicines on the environment and public health.
- Tackling antimicrobial resistance (AMR): AMR is considered one of the top three health threats in the EU. The reform offers incentives through transferable vouchers to companies that invest in novel antimicrobials that can treat resistant pathogens, addressing the current market failure. Measures and targets for prudent use of antimicrobials, including adapted packaging and prescription requirement, will also be introduced to keep the antimicrobials effective.
Peel and Reveal Labels
Peel and Reveal Wrap Around Labels are extended content labels and are printed front and back. These labels are typically used for additional printed patient or consumer information. The function of these labels allow a patient or consumer to peel back the label to access important information and re-seal the label without compromising the integrity. The easy-to-open and easy to reseal peel back label provides a complete solution for additional content requirements without excess packaging. The peel and reveal label is a solution for the copy and graphics required on OTC, generic, and pharmaceutical medications without needing a booklet or leaflet extension.
Multi-Ply Labels, a popular labelling solution, are composed of multiple layers of pressure-sensitive material, with a hinge and release agent that enables the top layer to be easily peeled back, opened, and resealed. CCL Healthcare’s construction of this label facilitates repeated opening and re-closing, thereby meeting regulatory requirements.
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In summary, Multi-Ply Labels offer a versatile labelling solution for brands looking to maintain their brand identity while meeting regulatory requirements. With customisable printable surfaces, easy-to-use design, and the ability to fit a variety of container shapes and sizes, Multi-Ply Labels are an excellent choice for a wide range of applications.
The pharmaceutical industry has undergone a significant transformation in their labelling and marketing strategies. The new EU laws will definitely have an impact on the type of labels you want to use. Peel-and-reveal labels provide additional space to include more regulatory, product or promotional information than traditional labels allow. These booklets can be opened and closed repeatedly with several folding/closing options available for practically any container.