Plans to vary the length of time that pharmaceutical manufacturers will have exclusive rights to exploit data depending on criteria they fulfil have in general been backed by members of the European Parliament (MEPs). Protection would be linked to the extent of their clinical trials activity and the location in which they carry out research, among other factors.
The proposals concern regulatory data protection and form part of a wider package of reforms to the EU’s general pharmaceutical legislation, which was initiated by the European Commission last year. Since the Commission published its plans, EU law makers in the European Parliament and Council of Ministers have been scrutinising the proposals. Both institutions must ultimately agree on – and formally adopt – the wording of the proposed legislation in order for it to become EU law.
In fixing its negotiating position on the plans last week, the Parliament has given its broad backing to a central plank of the Commission proposals – moving from a fixed system of varied regulatory data protection for all medicinal products for human use, to a new system where the protection available varies depending on the criteria products and their manufacturers are able to fulfil.
However, a statement issued by the European Parliament highlighted some differences between what MEPs support in relation to the changes to regulatory data protection and what the Commission had originally proposed.
“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,” the Parliament’s statement said.
“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 half years,” it said.
“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,” the Parliament said.
The Commission had proposed reducing standard regulatory data protection period from the current eight years to six years, but allowing for extensions of that protection to up to 12 years in certain cases if various conditions were satisfied – including if manufacturers make the new medicines available across all EU member states, if the product addresses an unmet medical need, if the manufacturer carries out comparative clinical trials, or if an additional therapeutic indication is identified for the product.
The Commission further proposed changes to the market exclusivity period that so-called ‘orphan drugs’ – medicines earmarked for treating rare diseases – benefit from. Under its proposals, the existing standard 10-year market exclusivity incentive, that applies after marketing authorisation has been granted, would be revised down to nine years, though new orphan medicines addressing a “high unmet medical need” would be eligible for 10-year market exclusivity. MEPs have proposed that orphan drugs should benefit from up to 11 years of market exclusivity if they satisfy the ‘high unmet medical need’ criteria.
Further proposals set out by the Commission have also been broadly backed by the Parliament, including plans to introduce a new ‘transferable data exclusivity voucher’ to incentivise the development of new antibiotics. Those vouchers would enable product manufacturers to confer an addition 12 months of regulatory data protection on any product that has obtained marketing authorisation – except products that already benefit from the maximum period of regulatory data protection.
A new environmental sustainability regime is also planned under the reforms to the EU’s general pharmaceutical legislation. MEPs have backed those proposals, which would add environmental risk assessment requirements to the process of obtaining marketing authorisation for new products.
One industry body in Germany, the Association of Research-based Pharmaceutical Companies (VFA), has criticised the MEPs’ proposals as “a missed opportunity”. It specifically referenced the proposals on regulatory data protection as “weakening” the existing regime and described this as “innovation-hostile”. The VFA has called on the Council of Ministers to “set the course for sustainable framework conditions and to take into account the interests of medicine, industry, and research equally”.
“Anyone who wants to strengthen competitiveness must offer predictability and certainty of expectations,” the VFA added. “Research-based pharmaceutical manufacturers need the assurance that investments in cutting-edge research are made in reliable framework conditions. And we do not see this assurance in Europe to a sufficient extent.”
Munich-based Marc Holtorf, an expert in life sciences regulatory and intellectual property law at Pinsent Masons, said there are pros and cons for pharmaceutical businesses within the proposed reforms to the EU’s general pharmaceutical legislation.
“On the positive side, the EU pharma package aims to improve safety and quality of pharmaceutical products, enhance transparency in the industry, and streamline regulatory processes,” Holtorf said. “This can give businesses greater confidence in the products they are sourcing and selling, as well as potentially reducing barriers to market entry for new products.”
“However, the increased regulatory requirements and compliance costs associated with the EU pharma package, such as new environmental risk assessment or marketing authorisations, or the requirement to publish a report listing all direct financial support received from any public body for the research and development of the medicinal products, can also pose challenges for pharma businesses. Companies may need to invest more resources in complying with the new regulations, which could increase their operational costs. Additionally, the stricter regulations may lead to more rigorous inspections and enforcement actions, which could impact businesses´ ability to bring products to market or maintain existing operations,” he said.
Pavlína Hlavenková, also of Pinsent Masons in Munich, added: “Overall, businesses linked to pharma will need to carefully evaluate the implications of the EU pharma package on their operations and be prepared to adapt to the changing regulatory landscape in order to remain competitive in the European market.”
Separate plans to help biotech companies bring new products to market faster are under consideration by the European Commission.
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