The Swedish government this summer has gone on to provide an opportunity for more than 120 stakeholders so as to share their viewpoints on the new EU pharmaceutical package that was put forward by the European Commission in April 2023. More than 70 individuals have gone on to send their comments to the government.
The new legislation looks to ward off a range of contemporary challenges. The Commission states that there are challenges with the timely availability and equal access of medicines as well as treatments throughout all EU member states, and also concerns about pricing that’s fair and affordable.
It is well to be noted that investments often fail to focus on significant unmet medical needs, like cancer treatments, paediatric diseases, as well as orphan diseases. In addition, the high prices when it comes to innovative new medicines and drugs continue to remain a concern in many European Union countries.
The Commission looks to address the impact of the environment on medicine production in line with the goal of the European Green Deal. Additionally, they also aim to tackle antimicrobial resistance by releasing exclusivity vouchers, which are meant to incentivize companies in order to develop new antibiotics.
The rising cost risk
It is well to be noted that in Sweden, the public sector and the pharmaceutical industry are happy to witness the ongoing modernization when it comes to regulations. That said, there are certain concerns as well.
The fact is that the Swedish Association of Local Authorities and Regions- SKR realises that the reforms have set the right goals but also expresses concern about their potential insufficiency in attaining the desired outcomes.
Maria Landgren, the manager for pharmaceutical issues at the SKR, expressed her concern about the proposal by the Commission, thereby highlighting a significant imbalance in their focus on boosting and also approving new medicines.
The association also goes on to recognise a potential risk associated with the use of exclusivity vouchers. They believe that this form of financing lacks transparency and might have a substantial economic impact on healthcare system costs in the times ahead. Another possible outcome is the potential transfer of important national decision-making to the EU level. This could occur if the European Medicines Agency is assigned more responsibilities.
Norrbotten, a region situated in the northernmost part of Sweden, believes that the recently implemented difficult system when it comes to data protection as well as market exclusivity regulations in the pharmaceutical industry might be utilised to preserve elevated drug prices.
If this is the case, the pressure on Sweden’s healthcare systems will persist and remain unresolved.
The Swedish Association of the Pharmaceutical Industry, known as LIF, goes on to represent 90 private companies. LIF is pleased with the reforms, as they have the potential to streamline and enhance the efficiency of the application process for market authorizations and also other regulatory procedures.
However, they also emphasise the need for substantial enhancements in the case of incentives and competitiveness. Johan Farnstrand, the CEO of the association, goes on to explain that the proposed declines in regulatory data security and other incentives outweigh the positive effect of the suggestions made in this part.
The Commission proposes reducing the regulatory protection for medicines from 10 to 8 years. Additionally, there is also a provision for up to 2 extra years of protection if novel drugs are launched in all member states within a span of 2 years.
He cautions that the competitive conditions in the life sciences sector are at risk of being weakened.
According to Farnstrand, this implies that both Sweden as well as the EU will experience negative consequences. Specifically, the research and development of new medicines will shift outside of the EU, resulting in a decline in the percentage of new treatments accepted within the EU.
Input from patients
The Swedish Disability Rights Federation, which comprises 52 member associations, supports the implementation of new incentives for the development of medicines. That said, they also advocate for the inclusion of generic drugs in this policy.
Access to medicines for patients has deteriorated both during the pandemic and subsequently due to the ongoing war in Ukraine. As per the chairman of the federation, Nicklas Martensson, they are pleased that the EU pharma package is now addressing concerns when it comes to patient access.