Incorporating Software in Combination with Medical Devices Hardware
Published Dec 04, 2023
Published 14th August 2023
The European Commission presented its draft for a comprehensive reform of the pharmaceutical legislation on 26 April 2023.
The existing legislation grants medicinal products eight years data protection with a 10 year market protection extendable to 11 years. The aim was to balance a period of exclusivity for pharmaceutical companies to ensure a return on the high investments needed to develop new medicines , to ensure a market for affordable medicines, and maintain the competitive function of the EU internal market.
The objective of the new proposed pharmaceutical legislation is to ensure equitable access to patients across the EU/EEA. The proposed legislative framework looks to create incentives to ensure the development of priority medicines where there is a high unmet need.
The EU proposals for the regulatory protection periods targets a variable duration split between standard and conditional periods to balance the incentives for innovation and support timely access to patients. Chapter VII of the proposed Directive determines the regulatory data and market protection period.
Overall, the marketing of innovative medicines would have a minimum of eight years regulatory protection made up of six years data protection and two years market protection. This standard protection is a marked reduction compared to the existing 8 years data protection and 2 years market protection for all new actives. Nevertheless, the additional conditional protection to be offered could allow companies to extend the protection periods up to 12 years as opposed to the current 11 years under the current directive.
Under Article 82 of the proposed Directive, additional protection periods could increase the total period to a maximum of 12 years (compared to the 11 years of the current legislation). These additional protection periods require certain conditions which target to incentivise.
An additional 2 years data protection will be granted if the product is launched in all member states within two years of the initial grant. There is some additional flexibility provided for not for profit organisations and SMEs with an additional 12 months on meeting the conditions. It is estimated that this incentive could increase access to medicines across EU by 15%.
However there is clarity needed on what is considered sufficient quality of supply to meet the condition of extending the data protection and how this assessment by individual member states in the case of decentralised procedure will be interpreted.
The industry are concerned that the two years to meet the product launch in all 27 member states is flawed. The delays in access to new medicines are often related to the national pricing and reimbursement decisions which is outside the remit of the European Commission. Addressing the variation in access to medicines requires further collaboration of partners involved across Europe in the pricing and supply of medicines.
An additional six months data protection will be granted at the time of marketing authorisation for a product treating a life threatening or severely debilitating condition where there is no authorised products tin the EU or where the product is providing meaningful reduction in disease morbidity or mortality.
An additional six months data protection will be granted at the time of marketing authorisation where the development of the new active substance incorporates clinical studies utilising an evidence based comparator The application for this extension will rely on scientific advice being sought to confirm the comparator studies. There is question on how many innovative medicines may benefit from this provision as many products may not have the scope for comparator studies
An additional one year protection period could be granted for a new indication where there significant benefit over existing therapies, if granted during the l data protection period The additional one year can only be granted once regardless on the number of new indications added to a marketing authorisation. It is not clear at this stage if the additional indication needs to be granted in the initial standard six year data protection period or can be within the extended period granted from additional supply conditions
Currently there is only an additional one year protection where an existing medicine is re-developed for a new indication. The proposed legislation recognises the need to consider additional incentives for drug re-purposing and introduces the new provision of 4 years data protection for a new indication where there is significant non clinical and clinical studies and the medicinal product has not benefited from previous data protection or the original marketing authorisation was granted more than 25 years ago.
Within the transferable voucher scheme there is the option for a company to apply for an additional one year data protection for a priority anti-microbial if applied in the first four years of data protection Further detail on this initiative is discussed in our blog Addressing Antimicrobial Resistance: EU Commission Objectives.
Orphan medicines will benefit from the same regulatory protection periods as innovative medicines. In addition the market exclusivity specifically allocated for Orphan medicines includes a standard nine years but can be extended to 10 years where it has a recognised high unmet need. In addition if the product is launched within two years in all 27 member states a further year exclusivity is granted. Nevertheless the challenge to launch an orphan product in all member states could be an impossible hurdle. There could be the possibility to waive the condition for launch if it can be justified in a particular member state. An additional year exclusivity can be granted for each new orphan indication up to a maximum of two years. More detail on the proposed changes for Orphan medicine can be found in our previous blog EU Pharmaceutical Legislation Proposal: Regulatory Impact to Orphan Designations.
A six month extension of market exclusivity based on the extension of the supplementary protection certificate continues to apply for the medicines developed for a paediatric indication. Although this cannot be claimed if the one year data protection for a new indication is already claimed.
The European Commission’s proposal will aim to encourage a competitive internal EU market, foster innovation and improve access to medicines across all member states. It is a tight-rope walk to balance the innovative medicines development with regulatory data protection incentives and enhance access to generic medicines. Regulatory data protection is complementary to intellectual property protection and vital to mobilise investment in high risk biotech developments.
The proposed changes do reduce standard periods of protection and introduce conditional incentives to promote supply of products. This will create a regulatory burden as MA Holders will need to apply for the extensions to the protection period. The variation in protection periods based on meeting certain conditions could make calculating the protection periods more challenging for regulators and introduce challenges from generics.
The proposal will be under debate and there is likely to be some opposing views from member states across the EU so there could be further updates to the data protection periods and the common ground to suit all territories is considered.
DLRC will continue to monitor the updates to review how the changes will impact new developments and the need to adapt innovation to maximise the benefit from the proposed incentives. Find out how this will effect your business by contacting our experts using the link below.