Sweden aims to keep current data protection period in EU pharma package [Advocacy Lab Content]

The Swedish government is opposed to shortening the regulatory data protection period (RDP) for new medicines, as currently proposed by the EU Commission in its pharma legislative overhaul. Swedish key stakeholders are demanding a stronger focus on patients and healthcare.

The EU parliament plenary voted this week on its compromise proposal to the pharmaceutical legislation reform.

In one of the most controversial areas – the baseline RDP – the European Commission wants to reduce the current period from eight to six years. A majority of the MEPs voted, however, for a minimum regulatory data protection period of 7,5 years

At the same time, the EU Council working groups will now discuss the data protection period and industry incentive models.

In a speech in December, Swedish Health Minister Acko Ankarberg Johansson (Christian Democrat) stressed the need to strike a balance between “a future-proof regulatory framework that contains the right balance of medicines for all patients and the best conditions for the development of innovation of new medicines.” What this balance means is not yet clear.

In a statement in early March, Acko Ankarberg Johansson and her party leader Ebba Busch, the Deputy Prime Minister and Minister for Energy, Business and Industry, said that data protection for new medicinal products must be strong, at the same time pointing at the Swedish pharmaceutical exports, which amounted to SEK 141 billion (€ 12,3 billion) in 2022.

Sweden wants eight years of RDP

On 22 March, an interview with Acko Ankarberg Johansson appeared in Life-Time, the media channel of LIF, the Association of Research-based Pharmaceutical Companies in Sweden, where she declared that the government wants to maintain the current baseline of eight years of data protection, which would be in line with industry demands.

“Companies are not investing, not doing clinical trials, not putting their products on the market in the same way as they do in other parts of the world,” she argued.

On the other hand, according to the EU Commission, there is a need to reduce the minimum data protection period to six years in the EU, which compares to five years for small molecules in the US and six years in China.

It proposes incentives, such as “carrots”, that could give a pharmaceutical company extra data protection time for a new drug if, for example, it addresses unmet medical needs in Europe or is made available in all 27 member states.

“The same net impact”

This mix should “ensure no additional costs for national health systems by modulating the incentive system so that the net impact is the same as today while more public health objectives are achieved,” the EU Commission explained on social media, quoting its earlier Impact Assessment report.

The Swedish Health Minister now calls these conclusions into question.

“I understand that the Commission believes that the overall package would still lead to an improvement. But my view is that it does not do so in the current system; it must change. We need to keep the data protection rules as they are today, but we also need other measures that will increase the EU’s competitiveness,” Acko Ankarberg Johansson told Life-Time, notably without making any declarations as to the government’s views on the proposed incentive models.

Sustainable healthcare

At the same time, two Swedish key stakeholders, the Swedish Association of Local Authorities and Regions and the Swedish Dental and Pharmaceutical Agency, recently called for a stronger and “sustainable” healthcare perspective, saying Swedish policy should be more focused on patients’ “real needs” and reward new medicines with a documented added value for patients.

“Pharmaceutical companies should get good conditions to develop new medicines. But these must also be affordable for the healthcare system and available for patients, Susanna Eklund, a senior investigator at the Swedish Association of Local Authorities and Regions, told Euractiv.

Generics in a reasonable time

“Generic medicines must be able to enter the market within a reasonable time, “she added, without specifying an exact data protection period.

An extra year of basic data protection beyond the proposed period would – according to the EU Commission’s estimates – cost €1.23 billion, while an additional 2.5 years would cost taxpayers around €5 billion.

Meanwhile, according to Jenni Nordborg, LIF’s Director of International Relations, different calculation models “give different results in terms of incentives”.

“The EU Commission’s current proposal on a data protection period creates above all uncertainty for investment decisions and risks fuelling the negative trend of more and more medicines being researched, developed, and clinically tested in other parts of the world,” she told Euractiv.

She also added that LIF welcomes the Swedish stand on the eight-year baseline RDP and is positive to the proposed incentive model to combat antimicrobial resistance. But other factors, such as the design of the so-called Bolar exception, would also be important for the industry ahead.

Increasing survival rates

Margareta Haag, chair of the Swedish Network against Cancer – which is an umbrella association for cancer patient organisations – told Euractiv that they have high hopes that new precision medicine therapies will increase survival rates among cancer patients.

However, those clinical trials, in general, have been falling in Sweden in recent years.
For these reasons, she hopes that maintaining eight years of basic data protection will attract pharmaceutical companies to come and conduct research in Sweden, she said.

“We want Sweden to be a magnet for life science companies,” Haag told Euractiv, adding that a central reason for the decline of clinical trials is Sweden’s “complicated” division of healthcare into 21 self-governing regions.

Euractiv asked the Health Minister for comments on the government’s policy regarding the pharma legislative package, but her press office declined the request for now, deferring to a later date.

[By Monica Kleja, edited by Vasiliki Angouridi, Brian Maguire | Euractiv’s Advocacy Lab]

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