The European Parliament (EP) is refining its position on two new proposals in the EU’s ongoing pharmaceutical package deliberations – a contested directive and a regulation. Czech MEP, Kateřina Konečná, shadow rapporteur of the new pharma package, favours the European Commission’s proposal for a regulatory data protection period while criticizing a shift from paper to digital medicine leaflets.

The overarching aim of the EU pharmaceutical package is to create a market for medicines that will ensure timely access for patients while providing an attractive research and development environment for companies in Europe.

The proposed directive focuses on authorisation, labelling, regulatory protection, and procedures for all medicines authorised at an EU and national level. The regulation under discussion sets additional, specific rules for medicines authorised at the EU level, particularly the most innovative ones. It also sets out rules for the management of critical medicines supplies.

Paper to digital leaflets

Euractiv spoke at length with Konečná (The Left), shadow rapporteur for both directive and regulation, she remarked: “The situation with the directive is very complicated because there is a right-wing rapporteur who relatively goes along with the pharmaceutical industry. This is reflected, for example, in her pressure to abolish paper leaflets for medicines, or her efforts to extend patent protection for medicines.”

The directive’s rapporteur, Pernille Weiss (EPP), argues that when it comes to medicine leaflets, mandatory formats should be decided by member states.

“The decision to make information available only electronically shall lay with each Member State, and in this case, patients shall be made aware of their right to a printed copy,” Weiss stated in her draft report, adding that if states require only a digital version, manufacturers may provide a paper leaflet on a voluntary basis.

Konečná sees the abolition of the EU obligation to provide the paper leaflet as a “very bad move that will severely damage the rights of people who are not digitally literate, especially the elderly.”

“I even believe that it is potentially health threatening. You will not always have access to the internet to download it, and you will be faced with the dilemma of taking a medicine that you are not sure how to take or waiting it out until getting to the internet,” she added.

Long patent protection

Another thorny issue is the length of patent protection for innovative medicines manufacturers. The European Commission proposed a reduction of the baseline period of regulatory data protection from eight to six years. In addition, medicines manufacturers would be granted two years of market protection.

Additional years of protection can be granted if the manufacturers meet criteria such as the launch of the medicines in all EU member states. With this approach, the Commission wants to motivate innovative companies to make their products more accessible across borders.

Rapporteur Weiss agrees with the incentives, but in her draft report, she proposes to prolong the baseline period of regulatory data protection to nine years, arguing that manufacturers need certainty and long-term predictability.

The Czech shadow rapporteur has a different approach.

“If the last two decades have shown us anything, it is that excessively long patent protection reduces the availability of medicines and, conversely, does not encourage manufacturers to develop medicines that we need or to enter the European market,” Konečná claims.

She commented that the problem is also visible in the case of drugs for rare diseases. “There is no cure for most rare diseases discovered so far. For many reasons, it is not lucrative to develop them. Those that have been developed then cost absurd sums,” she said.

Konečná is convinced that long patent protection can only be granted under clear criteria. These criteria should include the development of economically non-lucrative medicines and absolute transparency regarding the public budgets spent on their development.

Moreover, she suggests that if unprofitability is the reason why new drugs are not developed, public funds should be involved but “always in combination with a proportional reduction in the length of patent protection.”

Research outflow from Europe

The pharmaceutical industry has voiced an opposite opinion, claiming that a reduced protection period will lead to further outflow of research and development of new drugs to other parts of the world – to the United States, for example.

Expressing its strong concerns, EFPIA, the European Federation of Pharmaceutical Industries and Associations, has stated that the Commission proposal undermines the predictability of the existing intellectual property framework in the EU and will harm the innovation pipeline, reducing investment in innovative medicine by 55% in the next 15 years.

EFPIA argues that the result will be an overall failure to improve access to medicines for European patients. Specifically, they said, according to an impact assessment commissioned by EFPIA and conducted by Dolon, the proposed changes “might lead to the ‘loss’ of 45 orphan medicines expected in Europe by 2035.”

[By Aneta Zachová, Edited by Vasiliki Angouridi, Brian Maguire | Euractiv’s Advocacy Lab ]

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