During the April 10-11 plenary, Members of Parliament will vote on the European Parliament’s position on the proposed reform of pharmaceutical legislation. The direction seems to be to extend the regulatory protection of medicines to 7.5 years from the 6 initially proposed by the Commission.
Among those most vocal about the draft text is Sandra Gallina, Director General for Health and Food Safety at the EU Commission.
In this interview with TrendSanità, Gallina talks about the most important document this legislature will leave to the next and and the “silent pandemy” of antimicrobicoresistance.
Reform and innovation
Doesn’t the great debate that has broken out around the pharmaceutical reform proposal paradoxically risk slowing down innovation? We are talking about a very dynamic sector and these divergences risk further slowing down the legislative process. Is there a risk of dismissing a text that will not keep up with the times?
«We have designed the incentives system so that each euro spent means that European patients will get more and better medicines, at a faster pace. First, the reform is designed to reward innovation, notably in areas where no treatments are available. This includes, for example, rare and paediatric cancers, neurodegenerative diseases or vaccines and antimicrobials. For orphan medicines (medicines for certain rare diseases where there is a small market), we propose an extremely generous incentives system of 9+ years guaranteed protection.
Secondly, we have designed the reform to ensure that the digital transition and regulatory adaptations make the EU framework future-proof and innovation friendly. These simplifications are expected to generate savings of up to 300 million euros annually for companies and public authorities. We are confident that these measures will both ensure that the EU remains an attractive destination for investment and innovation».
Today, timeframes between Member States to access drugs approved by the EMA differ. What can Europe do to reduce these inequalities (in addition to the incentives for pharmaceutical companies envisaged in the reform proposal)?
«Our proposed reform will deliver very concrete solutions to this challenge. Today, clock stops extend approval times to over 400 days. The reform is designed to reduce this drastically.
There will be a pre-screening of marketing authorisation applications, meaning there will no longer be any immature applications entering the system. Importantly, the legal timeline to assess a new medicine will be significantly reduced. For instance, the European Medicines Agency (EMA) assessment will go from 210 to 180 days, and the Commission authorisation from 67 to 46 days. The number of EMA Committees will also be reduced from 5 to 2, which will translate into swifter approval timeframes, while maintaining the strict EU standards of safe, efficient and quality medicines. Timeframes for national authorisations will also be reduced».
Industry concerns
The Italian industry has put forward several criticisms of the reform proposal: how has it been received in other countries? Why, from your point of view, is Italy putting up this great resistance?
«Industry concerns are very much focused on one specific aspect of our proposals, namely our proposed incentives without recognising all the measures that will support innovation. The Commission’s impact assessment and the Copenhagen Economics study on incentives both demonstrate that changes to incentives in one country do not reduce pharmaceutical innovation in that country. Moreover, a reduction of the standard data protection would not put EU companies at a disadvantage or reduce innovation in the EU specifically.
Industry has long advocated for many of the measures that are proposed in the reform. These include the digital by default aspects, including electronic information leaflets, the use of real-world evidence for regulatory purposes, faster authorisations and early scientific advice. Industry was also in favour of a voucher incentive for game-changing antimicrobials and a sandbox provision to foster groundbreaking innovation. All of these elements are in our reform proposals and will benefit companies, especially SMEs, which are also provided with additional regulatory support.
In fact, we are already taking steps which will simplify the regulatory process for the pharmaceutical industry, as part of the reform. In early March we proposed to amend the variation legislation for medicines, in order to facilitate more efficient lifecycle management of medicines. The new framework drastically reduces the administrative burden, while creating a regulatory pathway to reap the benefits of scientific and technological advances, in the interest of patients».
Cooperation among Member States
What about drug shortages? How do we push Member States to cooperate?
«Addressing shortages and improving the security of supply of medicines have been key priorities right from the start of our Pharmaceutical Strategy for Europe. Based on the European Health Union package of measures the Commission put forward in November 2020, the mandate of the EMA was extended in 2022 to give it greater tools to address shortages. Notably the Medicines Shortages Steering Group brings together the Member States as a forum for cooperation and coordination.
With our reform, we will be better able to predict and mitigate shortages of medicines. Collaboration between EU Member States is fundamental to achieve this. We recently announced that some of the proposed elements to tackle shortages could be fast-tracked, while negotiations on the reform are ongoing.
In December, the Commission adopted the first EU list of critical medicines, for which continuity of supply must be a priority. We will also bring out recommendations on measures to be taken by companies or other supply chain actors to mitigate shortages. Where necessary, legally binding obligations to strengthen the security of supply of specific critical medicines will be enforced. This could include, for example, a requirement to maintain contingency stocks. When critical shortages do occur, the European Medicines Agency will coordinate the management of those shortages, which will also improve the situation. The reform will also facilitate the use of electronic product information and multi-country packages, which should help to reduce shortages».
Most clinical trials are conducted at a local level: why can’t we really cross borders with clinical trials?
«Although clinical trials are conducted in each Member State separately, due to them being registered at national level and to national networks of clinical research centres, the Clinical Trials Regulation provides the opportunity to coordinate clinical trials at European level. This involves a selection of Member States where the sponsor is willing to investigate a potential candidate medicine. This mechanism was widely used in the context of COVID-19 pandemic, where most of the clinical trials to test new treatments were multinational, hence benefiting patients across the whole of the EU. We hope to see more cross-border clinical trial cooperation in the future, in line with our legislation».
Fighting bacteria at the European level
The European strategy to combat AMR appears slow compared to the dramatic dimension of the problem: is this really the case?
«Combatting AMR is a top priority for the European Commission, and we are increasingly tackling it through a One Health approach.
Important policy and legislative developments to strengthen our response to AMR have taken place during this Commission mandate. These include the target of a 50% reduction of sales of antimicrobials for farmed animals and aquaculture by 2030, the ban of the routine use of antibiotics for prophylactic purposes to groups of animals or as growth promoters in farm animals and the most recent 20% reduction of antibiotic consumption by 2030. We have recently invested EUR 50 million to support EU Member States, Iceland, Norway and Ukraine, on infection prevention and control, surveillance and monitoring, prudent use of antibiotics and innovation.
We cannot however rest on our laurels. Initiatives need to be coordinated across countries and sectors and supported by investment and research. We are also pushing for more action to tackle AMR, through a One Health approach, at international level, as this is truly a global issue».
Reducing the use of antibiotics, both at the animal and human level, is a tiresome cultural struggle: where are we? Are there countries that respond better to European indications? Any MS specific information?
«Our EU targets aim to reduce the use of antibiotics and ensure that all Member States move in the same direction on this issue. At EU-level, the sale of antibiotics for animals fell by 44% between 2014 and 2021, due to EU legislation in this area.
However, in humans, consumption remained relatively stable or decreased too slowly.
A recent report by the European Food Safety Authority shows that reducing antibiotic consumption really can have an impact. In countries that managed to significantly reduce consumption, a drop in antimicrobial resistance was observed. The link between antimicrobial consumption and antimicrobial resistance is therefore clear and should spur us on to do more in this direction.
Member States have different starting points that need to be considered
As is the case with most EU policy, we must consider that all Member States have different starting points. For instance, the Nordic countries use very little antimicrobials on animals and therefore have favourable resistance statistics. However, some southern Member States with higher consumption figures have achieved remarkable reductions in recent years. Spain, for example, reduced the sale of animal antimicrobials by 62% between 2011 and 2022».
What is from your point of view the most important step that the EU has taken in recent years to fight AMR?
«I don’t think there is any individual measure that should be singled out above others. Rather, the fact that we are addressing this major threat through a One Health approach is crucial. AMR affects humans, animals and plants. It impacts healthcare, food production, animal health and welfare, environmental policy and our economies. Therefore, the only way that we can tackle this issue is through a multi-sector, multi-policy approach. That is the basis of the EU’s One Health approach to fighting AMR.
In order to fight AMR, we have deployed a number of different tools, such as legislation, guidance and training programmes. In doing this, we have achieved great progress in the food and veterinary sector over the years, mainly through legislation on use and hygiene. We anticipate that the Council Recommendation on AMR, agreed last year, will help deliver similar progress on the human health side.
At international level, we will continue to be a strong advocate for a coordinated response to combat AMR from the global community. The UN General Assembly high-level meeting on AMR in September will set the stage for the coming years and where we will push for concrete commitments and the One Health approach. We also actively seek to include actions to prevent pandemic situations related to antimicrobial resistant pathogens in the negotiations for an international agreement on combating pandemics within the framework of the WHO International Agreement on Pandemic Prevention, Preparedness and Response».
