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EU Commission proposes to revise the EU’s pharmaceutical legislation to adapt it to the needs of citizens

Apr 26, 2023 , , , , , ,

Brussels, 26 April 2023
Today, the Commission is proposing to revise the EU’s pharmaceutical legislation – the largest reform in over 20 years – to make it more agile, flexible, and adapted to the needs of citizens and businesses across the EU. The revision will make medicines more available, accessible and affordable. It will support innovation and boost the competitiveness and attractiveness of the EU pharmaceutical industry, while promoting higher environmental standards. In addition to this reform, the Commission proposes a Council Recommendation to step up the fight against antimicrobial resistance (AMR).

The challenges this reform addresses are fundamental. Medicines authorised in the EU are still not reaching patients quickly enough and are not equally accessible in all Member States. There are significant gaps in addressing unmet medical needs, rare diseases and antimicrobial resistance (AMR). High prices for innovative treatments and shortages of medicines remain an important concern for patients and healthcare systems. In addition, to ensure that the EU remains an attractive place for investment and a world leader in the development of medicines, it needs to adapt its rules to the digital transformation and new technologies, whilst cutting red tape and simplifying procedures. Finally, the new rules need to address the environmental impact of medicine production in line with the objectives of the European Green Deal.

The revision includes proposals for a new Directive and a new Regulation, which revise and replace the existing pharmaceutical legislation, including the legislation on medicines for children and for rare diseases. It aims to achieve the following main objectives:

  • Create a Single Market for medicines ensuring that all patients across the EU have timely and equitable access to safe, effective, and affordable medicines;
  • Continue to offer an attractive and innovation-friendly framework for research, development, and production of medicines in Europe;
  • Reduce drastically the administrative burden by speeding up procedures significantly, reducing authorisation times for medicines, so they reach patients faster;
  • Enhance availability and ensure medicines can always be supplied to patients, regardless of where they live in the EU;
  • Address antimicrobial resistance (AMR) and the presence of pharmaceuticals in the environment through a One Health approach;
  • Make medicines more environmentally sustainable.

To achieve these objectives, the reform addresses the entire lifecycle of medicines.

Key elements of the proposal:

  • Better access to innovative and affordable medicines for patients and national health systems: new incentives will encourage companies to make their medicines available to patients in all EU countries and develop products that address unmet medical needs. Furthermore, earlier availability of generic and biosimilar medicines will be facilitated, and market authorisation procedures simplified. Measures for greater transparency of public funding of medicines development will be introduced and the generation of comparative clinical data will be incentivised.
  • Promoting innovation and competitiveness through an efficient and simplified regulatory framework: the reform will create an innovation-friendly regulatory environment for the development of new medicines and the repurposing of existing ones. The European Medicines Agency (EMA) will provide better early regulatory and scientific support for developers of promising medicines to facilitate the fast approval and help SMEs and non-profit developers. The scientific evaluation and authorisation of medicines will be sped up (e.g., EMA authorisation procedures will take 180 days, helping reduce the current average of around 400 days) and the regulatory burden will be reduced through simplified procedures (e.g., by abolishing in most cases marketing authorisation renewal and introducing simpler procedures for generic medicines) and digitisation (e.g., electronic submissions of applications and electronic product information). The highest quality, safety, and efficacy standards for the authorisation of medicines will be maintained.
  • Effective incentives for innovation: regulatory protection of up to a maximum of 12 years for innovative medicines, combined with the existing intellectual property rights, will ensure Europe remains an attractive hub for investment and innovation. To create a single market for medicines, the reform will move the current system away from its ‘one-size-fits-all’ regulatory protection towards a more effective incentives framework for innovation that also promotes public health interests. To achieve this, it proposes a minimum period of regulatory protection of 8 years that can be extended in the following cases: if medicines are launched in all Member States, if they address unmet medical needs, if comparative clinical trials are conducted, or if a new therapeutic indication is developed. The combination of the existing intellectual property rights and the new regulatory protection periods will also safeguard the EU’s competitive edge in pharmaceutical development, one of the most protective world-wide. The reform will drive efforts so that research and development will focus on the patients’ greatest needs and there is more timely and equitable patient access to medicines across the EU.
  • Addressing shortages of medicines and ensuring security of supply: the reform introduces new requirements for monitoring of shortages of medicines by national authorities and EMA and a stronger coordination role for EMA. Obligations on companies will be strengthened, including earlier reporting of shortages and withdrawals of medicines and development and maintenance of shortage prevention plans. An EU-wide list of critical medicines will be established, and supply chain vulnerabilities of these medicines will be assessed, with specific recommendations on measures to be taken by companies and other supply chain stakeholders. In addition, the Commission can adopt legally binding measures to strengthen security of supply of specific critical medicines.
  • Stronger protection of the environment: better enforcement of current environmental requirements will limit the potential negative consequences of medicines on the environment and public health.
  • Tackling antimicrobial resistance (AMR): AMR is considered one of the top three health threats in the EU. The reform offers incentives through transferable vouchers to companies that invest in novel antimicrobials that can treat resistant pathogens, addressing the current market failure. Measures and targets for prudent use of antimicrobials, including adapted packaging and prescription requirement, will also be introduced to keep the antimicrobials effective.
Stepping up EU actions to combat AMR in a One Health approach

Antimicrobials are crucial medicines. However, over the years, their overuse and misuse have led to increasing antimicrobial resistance (AMR), meaning that antimicrobials lose their effectiveness, and it becomes more difficult, if not impossible, to treat infections. Therefore, today’s package also includes a proposal for a Council  Recommendation containing complementary measures to combat AMR in the fields of human health, animal health and the environment, through the so-called One Health approach.

The proposal supports the prudent use of antimicrobials, recommending concrete and measurable targets to reduce their use and promote high levels of infection prevention, notably in hospitals, and control in the area of human health. The proposal also improves public awareness, education and training of relevant professionals and fosters cooperation between stakeholders from all relevant sectors.

Recommended targets were designed with the support of the European Centre for Disease Prevention and Control (ECDC) and take into account national situations (different levels of antimicrobial consumption, spread of key resistant pathogens across the Member States). They also allow better monitoring of progress in the coming years.

In addition, the proposal will boost national One Health action plans on AMR, foster research and innovation, reinforce surveillance and monitoring of AMR and antimicrobial consumption, enhance global actions, contribute to the design of an EU multi-country financial incentive to improve access to antimicrobials and incentivise the development of other AMR medical countermeasures such as vaccines and rapid diagnostics.

Background

In November 2020, the Commission presented a Pharmaceutical Strategy for Europe  which aims to create a future-proof and patient-centred pharmaceutical environment in which the EU industry can innovate, flourish, and continue to be a global leader.

An EU pharmaceutical ecosystem that is crisis-resilient and fit for today’s landscape and tomorrow’s challenges is one of the central pillars of a strong European Health Union and will complement other key initiatives, including the reinforcement of the EU health security framework with the new legislation on cross-border threats to health and stronger mandates for EU health agencies, the establishment of the Health Emergency Preparedness and Response Authority (HERA) as well as Europe’s Beating Cancer Plan and the European Health Data Space.

The Strategy kick-started an ambitious revision of the current pharmaceutical legislation, a comprehensive response to the current challenges faced in the EU pharmaceutical sector.

Next steps

The legislative proposals will now be submitted to the European Parliament and the Council.

For More Information

EU’s pharmaceutical legislation

Questions and Answers on the pharmaceutical legislation

Questions and Answers on the Recommendation on AMR

Factsheet on putting patients in the centre

Factsheet on driving innovation for pharmaceutical industry

Factsheet on tackling antimicrobial resistance

Pharmaceutical Strategy for Europe

EU Action on Antimicrobial Resistance

Video on the revision of the pharmaceutical legislation

Quotes

This proposal is a once-in-a generation occasion to overhaul a legislation which is crucial for patients and for the strengthening and development of one of the EU’s key industrial sectors. Our proposals aim at striking the right balance between promoting innovation and ensuring patient access to affordable medicines across the EU. They also take heed of the lessons learned from the COVID-19 crisis, showing once again that the EU can adapt itself to new global realities. Our EU Health Union is emerging as a one of the most tangible achievements of this Commission.

Margaritis Schinas, Vice-President for Promoting our European Way of Life – 26/04/2023

Today we add another central pillar to our European Health Union. We are putting forward proposals to ensure that medicines reach patients everywhere in Europe, in a timely and equitable fashion. It is a reform which ensures that Europe remains attractive for business, and our pharmaceutical industry a global innovation powerhouse. Building a single market for medicines is a necessity both for our citizens and our companies.

Stella Kyriakides, Commissioner for Health and Food Safety – 26/04/2023
Source – EU Commission

Opening remarks by EU Commission VP Schinas and Commissioner Kyriakides on the revision of EU’s pharmaceutical legislation *

 

Brussels, 26 April 2023
Remarks by Vice-President Schinas:

Good afternoon, I am proud to present today, with Commissioner Kyriakides, the revision of the pharmaceutical legislation. It is the most complex, neuralgic, epic, big package we have prepared in the area of health throughout our mandate.

This is one of the oldest pieces of legislation, about 20 years old. When we kickstarted the project three years ago, we were aiming to bring about a holistic, balanced review that is fit for purpose, modern and reflects all the lessons drawn from the pandemic and the word that we live in, much more complex than 20 years ago.

Before going into the details, let me give some context. When the legacy moment will come for this Commission, health will be an important chapter in the achievement of this Commission. Never before in the history of the European Union we were able to do so much in the area of public health. Not only in terms of management of the pandemic, but also in building an EU Health Union.

I am convinced that this chapter will be known as the untold success story of the European Union, keeping always in mind that the legal base of health policy in the treaties are not among the strongest ones when we develop policies for Europeans.

It all started with the EU vaccines strategy, the biggest ever vaccination programme in the history of mankind. It enabled access to lifesaving vaccines for citizens, regardless of the place of residence or socioeconomic conditions.

The Digital COVID Certificate, which gave us our lives back, became a global standard for more than 69 third countries. The reinforced mandates of our health agencies, EMA and ECDC. The creation of a new authority, HERA, that can ring the alarm before crisis hit us. The first-ever health programme in the EU budget, EU4Healt. The first-ever comprehensive European plan to beat cancer the first-ever proposal to create a European Health Data Space. All this is what we managed to achieve under this commission.

I take this opportunity to thank the President, Stella, and all the teams represented here for this impressive work.

The pharmaceutical package is the penultimate step in this process, probably the last legislative step of the term. We still have the mental health proposal coming in June.

When it comes to pharma. This is a package that is meant to address two objectives: a patient-centred approach. This gives more opportunities for patients, better access, affordability.

I take the opportunity to salute the presence of representatives of patients organisations today Welcome.

The other twin objective is the competitiveness of our pharma industry. It is a European champion, that needs to be given the chance to compete globally through innovation and make sure that, as a result of this review, they continue to be a European champion.

This translates into two sets of concrete objectives: what we characterize as the triple As (access, affordability, availability). But also, what I call the triple Cs (competitiveness, compliance, combatting AMR).

I will briefly illustrate those main objectives and then Stella will guide you through the concrete actions to make them a reality:

  • First and outmost is Access. We want our citizens, wherever they live in the EU to have equal access to medicines. It is not a secret that bigger and wealthier countries get medicines first and faster. The facto, this creates first- and second-class citizens. And we want to change that, through a smart system of incentives that replaces the current blanket protection system. The more you are compliant with enhancing market access the better protected your products are in the Single Market.
  • We also want to ensure that medicines are more Affordable for patients and for health-system. We want to see more generics coming in; we want to see prices coming down. We are not setting prices, this is a national competence. But there are many things we can do to influence the ecosystem around that. This can be done through simplification of procedure, rationalisation and the introduction of generics.
  • We will minimize shortages of medicines across the EU, enhancing Availability for all EU citizens. This is a crucial issue from a health perspective, but also a key contributor to Europe’s strategic autonomy, resilience and also security. Europe needs to maintain access to raw materials. We have high hopes that EMA will rationalise and coordinate this process to act together before we have the problem emerging.
  • At the same time, we wish to maintain the Competitiveness of the EU pharmaceutical industry, one of our crown jewels. The revised regulatory system will be simpler for authorisation, faster and SME’s friendly; it will also offer even longer protection of industrial activity than today – if specific conditions that are predictable and clear are met. Altogether, the new measures will generate up to €300 million savings annually for our industry.
  • And we want to do all this mindfully of the environmental impact of medicines, by ensuring Compliance with our Green deal and environmental goals. For now, it was more a box-ticking exercise, we want to make it a meaningful exercise.
  • We bring at the forefront action on Combatting antimicrobial resilience, the ‘silent pandemic’. This is a huge problem. It is becoming more and more of a threat. To address overuse and misuse of antibiotics, and to promote the development of more effective treatments through a system of incentives and transferable voucher

In a nutshell, we are building together a Single Market for medicines in the EU, one that works for citizens and for industry, 20 years since the legislation was inacted.

To conclude, I have to confess that, taking stock of all that we have achieved over the last few years in the area of health fills me with a sense of pride and appreciation.

The European Health Union is not a concept, a slogan, a verbal objective. It is action and it is happening.

Thank you.

*****

Remarks by Commissioner Kyriakides:

Ladies and gentlemen,

What we are presenting today represents the European Way of Life.

We cannot have first- and second-class citizens when it comes to accessing medicines in the EU.

This reform is about not leaving anyone behind.

On health inequality, Bono once said: “Where you live should not determine whether you live, or whether you die”.

This premise underpins the proposals of the European Health Union we have been building since 2020 with Europe’s Beating Cancer Plan, the European Health Data Space, the Cross-Border Health Threats Regulation, the strengthening of the mandates of the European Centre for Disease Prevention and Control, the European Medicines Agency and today, with our pharmaceutical reform proposals.

Today, we are acting on behalf of citizens, patients and industry.

Our proposals today are historic. This is  because it has been 20 years that our rules have been in place. These rules served a purpose, as they have delivered safe and effective medicines to citizens, but they have not delivered a Single Market for medicines. They also have not addressed the challenges surrounding inequalities in the area of medicines.

Every year, half of us purchase at least one prescribed medicine.

Every year, we spend 1.5-2% of our GDP on medicines.

The pharmaceutical industry is a key economic and innovative sector for the EU, worth €215 billion in exports every year.

In a European Health Union, access to medicines can no longer be fragmented.

Today, with our pharmaceutical legislation reform proposals we are presenting a toolbox that puts equal access at the centre of our European Health Union.

These proposals should not be seen in isolation, but as a toolbox that will bring about change in many different areas. Taken together, these actions will make the difference.

With our proposals we are aiming to have:

  • Equal and timely access for patients to more and better medicines.
  • Strong incentives for innovation and less burden on companies and regulators.
  • More affordable medicines and more sustainable healthcare costs for Member States and patients.
  • Less shortages of medicines and increased security of supply.

Today, whilst patients in Western and bigger Member States have access to 90% of newly approved medicines, in Eastern and smaller Member States, this number is as low as 10%.

EU citizens also have to wait anywhere from 4 months to more than 2 years for these medicines.

This is truly unacceptable.

The EU has ensured equal and simultaneous deliveries of lifesaving COVID vaccines to all 27 Member States.

Today, we act to address inequalities in access to medicines more broadly, by rewarding via a range of incentives companies that go the extra mile.

These incentives will provide access to new medicines to around 70 million more citizens compared to today.

We will provide 8 years of guaranteed regulatory protection.

In addition, 2 extra years will be given to medicines launched in all Member States, 1 more year for additional therapeutic indications,  6 extra months for unmet medical needs and 6 months for comparative trials.

We will continue to have one of the most competitive and industry-friendly incentive systems in the world.

Companies can still reach the 11 years of protection they have today, and go even higher to 12 if they fulfil all conditions.

However, it will be a system that rewards innovation while improving access.

Innovation has to reach patients to have value for society.

I spoke before of a toolbox of proposals. It is important that these proposals are seen as complementing each other.

Beyond incentives, we are aiming to build a, simpler, faster regulatory ecosystem.

We will reduce authorisation procedures and timelines to ensure that medicines reach patients faster.

This will mean, without compromising safety, we will have reduced assessment times for medicines from around 400 days today to 180 with the reform.

Overall, this administrative burden could save up to €300 million annually in costs for companies and authorities.

All of these actions are important for industry, as we expect this to generate large savings over the next 15 years.

Affordability of medicines is another critical issue for patients and healthcare systems.

National budgets today are struggling to keep up with the cost of medicines.

We propose that generics and biosimilars, which are cheaper can enter the market on day 1 after protections expire.

We will also help Member States to be in a stronger negotiating position when discussing market entry with companies.

We will be increasing transparency on public funding for medicine development and better availability of comparative clinical data.

Together with the new incentives, this will save billions for healthcare systems and patients.

Availability of innovative and essential medicines is another key pillar of the reform.

This is very closely linked to medicine shortages and security of supply. Over the last decade, reports of medicines shortages have skyrocketed..

To counter this, companies will have to notify potential shortages earlier and have shortages prevention plans for their medicines.

We will also establish for the first time an EU list of critical medicines to monitor the availability of essential medicines and address supply chain vulnerabilities. HERA will play an important part in this.

Antimicrobial resistance, the “silent pandemic”, is another headline issue in our proposals. AMR is already taking 35,000 lives in the EU every year, and it costs our healthcare systems around €1.5 billion annually.

Today, we propose a new toolkit to address the AMR market failure.

This includes transferrable exclusivity vouchers for new antimicrobials, prudent-use measures and measurable targets to address overuse and stimulate innovation in new products.

Finally, the environmental dimension goes hand in hand with our citizens’ health.

This is why we will strengthen our environmental requirements.

Ladies and gentlemen,

I will end as I began, by saying that this is a historic day for citizens, patients, and industry. We have here a reform after two decades to address and ensure access availability and affordability of medicines, while leaving no one behind.

And we have shown that we are stronger when we work together. We have shown that with collaboration and solidarity, we can bring results.

A strong European Health Union has a duty to act and deliver for our citizens.

Thank you.

*Updated 26/04/23

Source – EU Commission

FAQ: Revision of the Pharmaceutical legislation

 

Brussels, 26 April 2023

The Commission is proposing an ambitious revision of the EU pharmaceutical legislation to achieve the following main objectives:

  1.  Create a Single Market for medicines ensuring that all patients across the EU have timely and equitable access to safe, effective, and affordable medicines;
  2. Continue to offer an attractive and innovation-friendly framework for research, development, and production of medicines in Europe;
  3. Reduce drastically the administrative burden by speeding up procedures significantly reducing authorisation times for medicines, so they reach patients faster;
  4. Enhance availability and ensure medicines can always be supplied to patients, regardless of where they live in the EU;
  5. Address antimicrobial resistance (AMR) and the presence of pharmaceuticals in the environment through a One Health approach;
  6. Make medicines more environmentally sustainable.

The revision is the first major review of the pharmaceutical legislation since 2004. It will adapt the legislation to the needs of the 21st century.

1. What does the package consist of?

The reform includes two legislative proposals: a new Directive and a new Regulation which constitute the EU regulatory framework for all medicines (including those for rare diseases and for children), simplifying and replacing the previous pharmaceuticals legislation.

Simply put, the Directive contains all the requirements for authorisation, monitoring, labelling and regulatory protection, placing on the market and other regulatory procedures for all medicines authorised at EU and national level.

The Regulation sets specific rules (on top of the ones in the Directive) for medicines authorised at EU level, in particular the most innovative ones. It sets out the rules on coordinated management of critical shortages and security of supply of critical medicines. It also sets out the rules governing the European Medicines Agency (EMA).

The reform also includes a Council Recommendation on antimicrobial resistance (AMR).

Finally, these legislative proposals and Council recommendation are accompanied by a Communication that explains the rationale of the changes.

2. What is new in this reform?

The reform builds on the current high standards of quality, safety, and efficacy for the authorisation of medicines and proposes new tools in the following areas:

  • Move away from a “one-size-fits-all” system of incentives for pharmaceutical companies to a modulated system of incentives that rewards companies that fulfil important public health objectives, such as giving access to medicines in all Member States, developing medicines that address unmet medical needs, conducting comparative clinical trials and developing medicines that can treat other diseases as well. For medicines for rare diseases, a similar modulation for market exclusivity is proposed;
  • Faster availability of generics and biosimilars and transparency of public funding;
  • Addressing shortages of medicines and ensuring security of supply;
  • A modern and simplified regulatory framework with faster authorisations of new medicines. For instance, for its assessment, EMA will have 180 instead of 210 days. For the authorisation, the Commission will have 46 instead of 67 days. This will help to reduce the current average of around 400 days between submission and market authorisation. For the assessment of medicines that are of major public health interest, EMA will only take 150 days regulatory sandboxes supporting the development of innovative medicines, electronic submissions and e-leaflets;
  • Promotion of innovation and competitiveness;
  • Better protection of the environment;
  • Tackling antimicrobial resistance (AMR).
3. How will the new legislation promote innovation?
  • Many measures have been proposed to support the development of innovative medicines: the authorisation process for new medicines will be sped up, thanks to simplified procedures and a revamped EMA structure.
  • Early scientific advice by EMA will improve the quality of applications and tailored scientific support will be provided to SMEs. Learning from the COVID-19 experience, “rolling reviews” (i.e., a phased reviews of data as they become available), and temporary emergency marketing authorisations for health emergencies will be introduced.
  • Developers of innovative products will receive advice on their product even years before they actually apply for a marketing authorisation which will facilitate their decisions.
  • Regulatory ‘sandboxes’1 allow testing new regulatory approaches for novel therapies under real world conditions. The use of real-world evidence and health data is also facilitated. The regulatory framework will be more agile to accommodate scientific advances, digitalisation, artificial intelligence and cutting-edge products.
  • Special provisions and incentives for repurposing make it easier for researchers and not-for-profits to materialise their research into authorised medicines.
  • Special incentives are given for medicines delivering on high unmet medical needs in the case of rare diseases.
  • Companies marketing innovative medicines will have a minimum period of regulatory protection of 8 years, which includes 6 years of data protection and 2 years of market protection. Companies may benefit of additional periods of protection, increasing the total period up to maximum 12 years, while it is maximum 11 years today. These additional periods of protection can be obtained if the companies launch the medicine in all Member States (+2 years), if the medicine addresses an unmet medical need (+6 months), or if comparative clinical trials are conducted (+6 months). A further year of data protection can be granted if the medicine can treat other disease(s) too. The additional regulatory protection of 2 years if medicines are launched in all Member States is expected to increase access by 15%. This means that 67 million more people in the EU could potentially benefit from a new medicine.
  • For medicines for rare diseases, the standard duration of market exclusivity will be 9 years. Companies can benefit from additional periods of market exclusivity if they address a high unmet medical need (1 year), launch the medicine in all Member States (+ 1 year), or develop new therapeutic indications for an already authorised orphan medicine (up to 2 extra years). The regulatory production periods can add up to maximum 13 years while today the maximum is 10 years.
  • Moreover, a number of future-proofing measures will ensure that the regulatory system can keep pace with scientific and technological progress. This also comprises promoting innovative methods, including those aimed at reducing animal testing.

All these measures offer an attractive and internationally competitive regulatory protection, which is complementary to the current system of intellectual property rights offering businesses an additional reward for innovation.

4. Will the proposed reform have an impact on the Intellectual Property (IP) protection covering medicinal products?

No. The reform does not affect the EU system of intellectual property protection (IP) (patents, trademarks, copyrights, supplementary protection certificates). That means Europe will continue to offer a globally competitive system of IP incentives.

5. What is the AMR “vouchers” system about?

The development of novel antimicrobials is hindered by a market failure: to avoid the development of resistant bacteria, the use of antimicrobials should be restricted. But with limited sales prospects for innovative products, many investors are no longer interested in this area. Therefore, and without public intervention, we may find ourselves in a situation where there are very few or no new medicines capable of fighting multi-dug resistant pathogens in the future.

This is where the voucher system comes in. It will provide ‘transferable data exclusivity vouchers’ to developers of ‘game changing’ novel antimicrobials, which they can either use themselves or sell. The voucher will offer to the developer an additional year of data protection from competition for the medicine that the voucher applies to.

The system will generate revenues for businesses that successfully develop such revolutionary medicines, without direct financial contributions from Member States. Indirectly, and as a result of the longer protection period for the medicines to which it is transferred, the voucher is financed by the national health systems, but this cost will be largely counterbalanced by the prevented deaths and illnesses thanks to the novel antimicrobials.

The vouchers will be granted and used under strict conditions. They will be provided in limited numbers over a limited period (no more than 10 vouchers in 15 years) thus capping the potential burden on health systems.

6. How will the new rules give patients access to more and innovative medicines?

A central objective of the reform is to ensure that all patients across the EU have timely and equitable access to safe and effective medicines. Today, this is not always the case, especially for innovative medicines, as patient access varies between Member State.

The reform addresses this concern by making two years of data protection conditional on launching a medicine in all Member States.

A reduction of the standard regulatory protection period by 2 years (compared to today) and measures that encourage early market access of generic and biosimilar entry will also provide more affordable options to patients and contain health systems’ pharmaceutical expenditure.

Incentives for repurposing existing medicines and for using comparative trial data will give patients quicker access to new therapies that deliver on their needs. Using comparative trial data will help national authorities to better assess the cost effectiveness of a new medicine.

A simplified decision-making system reduces authorisation times for new medicines.

Incentives will be offered for the development of innovative medicines addressing unmet medical needs.

In addition to the existing paper leaflets, electronic product information will ensure accurate information to patients in their own language through electronic leaflets and help address shortages through the easier redirection of stocks to countries that need them.

7. Will the new rules impact the way medicines and vaccines are authorised in the EU?

Yes. The proposed reform cuts down the regulatory burden, with a leaner EMA structure. It simplifies procedures to ensure efficient assessments, boost the scientific capacity of the EU regulatory network and reduce the time for authorisation of medicines.

The reform also strengthens the voice of patients in the EMA by adding patient representatives to the main scientific committee.

8. How will changes to EMA’s work speed up the authorisation of medicines?

For the authorisation of the most innovative products, the European Medicines Agency (EMA) coordinates the work of national experts, through several committees.

The legal proposal therefore simplifies EMA’s structure to two main scientific committees for human medicines: the Committee for Human medicinal products and the Safety Committee (PRAC). The orphan, paediatric and ATMP committees would be discontinued.

The new, leaner structure is complemented by a stronger support for the two remaining committees (through working parties and expert pools). This will reduce the assessment time and free up scientific resources to strengthen pre-authorisation support to developers and gain efficiency.

The mandate of the EMA and its Executive Steering Group on Shortages and Safety of Medicinal Products will be extended with respect to the management of critical shortages and the security of supply of critical medicines

An inspectorate will be established within EMA to reinforce Member States’ capacities, in particular for inspections in third countries to build efficiency in surveillance and support marketing authorisation procedures.

9. Will there be more transparency on the development of medicines?

Yes. Currently, there is a lack of transparency on research and development (R&D) costs or public contributions to these costs. While R&D costs are not relevant for the assessment of a medicine’s benefit-risk balance, more transparency on public support for the development of medicines may strengthen the negotiating position of authorities responsible for pricing and reimbursement of medicines when negotiating prices with the pharmaceutical companies. This could help reduce prices and thereby improve access to medicines.

Pharmaceutical companies will therefore be required to publish information on all direct financial support for the research and development of medicines received from public authorities or publicly funded bodies. This information will be easily accessible to the public on a dedicated webpage of the company and through the database of medicinal products for human use authorised in the Union.

10. Will the reform tackle shortages of medicines?

Shortages of medicines have been a serious concern in the EU for several years. The COVID-19 pandemic in particular highlighted shortcomings of the current legal framework, negatively impacting patients, health systems and healthcare professionals.

The extension of EMA’s mandate as part of the European Health Union, allowed improving coordination and management of the supply of medicines shortages during crises.

Today’s reform, however, goes beyond crisis preparedness and response and will help addressing systemic shortages at all times. The new legislation will enhance the monitoring and mitigation of medicines shortages, in particular critical shortages, at national level and by EMA. Pharmaceutical companies will have to report shortages of medicines more quickly and establish shortage prevention plans.

Pharmaceutical companies will have to address critical shortages, and report on the results of the measures taken (such as the increase or reorganisation of manufacturing capacity or the adjustment of distribution to improve supply).

In addition, an EU list of critical medicines – i.e. medicines considered to be most critical for health systems at all times – will be established. Recommendations on measures to be taken will be made to companies and other relevant stakeholders to strengthen the supply chains of those medicines, to ensure continuity and security of supply for EU citizens. The legislation will also allow the Commission to introduce, through an implementing act, measures to strengthen security of supply, including requirements to establish contingency stocks.

11. Will the pharma reform address strategic autonomy and reshoring?

The pharmaceutical reform aims to enhance security of supply of medicines for EU patients and health systems, through preventative and reactive measures. It does so by proposing concrete measures, including the earlier notification of shortages and withdrawals, a company requirement to maintain shortage prevention plans for all medicines and the adoption of an EU list of critical medicines. The intention is to ensure the security of supply of those critical medicines, through recommendations on measures to be taken by supply chain stakeholders, and in certain cases by reinforcing those recommendations by imposing stronger obligations through Commission implementing acts.

Security of manufacturing and supply is a crucial element to ensure continued availability of medicines. Strategic autonomy and reshoring are not directly addressed in the proposal. However, there is sufficient flexibility to target specific vulnerabilities, including problematic dependencies, through those provisions described.

In parallel, the Commission is setting up the EU FAB flexible manufacturing project, which is a network of vaccine producers in the EU. It reserves manufacturing capacity and requires participating companies to ensure that we have the required capacity to produce medical countermeasures in the EU.

HERA has also established the Joint Industrial Cooperation Forum to find solutions to supply chain bottlenecks and vulnerabilities as well raw materials for medical countermeasures.

HERA is also working on a financial pull incentive for antimicrobials, notably in form of revenue guarantee.

The Important Project of Common European Interest on Health will allow participating EU countries to allocate state aid to support innovative EU projects in health, including those relevant for security of supply.

Finally, we have recently come forward with a proposal for Critical Raw Materials which also covers essential components to produce medicines and other medical countermeasures.

12. How will the fight against the environmental impact of medicines be enhanced?

Scientific evidence shows that the production, use and improper disposal of pharmaceuticals may have negative impacts on the environment. In addition, antimicrobials have been detected in wastewater treatment, manufacturing effluent, surface, and ground waters. This is concerning, as this boosts antimicrobial resistance. Endocrine disruptors are another major group of medicines that may pose a risk to the environment and public health.

In line with earlier commitments in the Strategic Approach to Pharmaceuticals in the Environment, the reform strengthens the environmental risk assessment (ERA) of medicines to limit the potential adverse impacts of medicines on the environment and public health. The ERA is mandatory for all pharmaceutical companies placing their medicines on the EU market. Marketing authorisation may be refused when companies do not provide adequate evidence that environmental risks were evaluated, and risk mitigation measures were taken.

13. What is the economic weight of the EU’s pharmaceutical industry?

The pharmaceutical industry is a key sector for the EU’s economy.

In 2020, EU companies invested more than €26,5 billion in Research and Development (R&D) and they are responsible for around 840,000 direct jobs. The EU, UK and Switzerland is the second biggest R&D investor in pharmaceuticals (€39.7 billion in 2020) after the US, which has invested €63,5 billion in 2020 (EFPIA data).

In terms of manufacturing high-tech medicines, the EU is a clear global leader. Exports have increased from €50 billion in 2002 to €235 billion in 2021, while imports grew from €32 billion to €100 billion in the same period. The EU’s trade surplus in medicinal and pharmaceutical products reached €136 billion in 2021, the highest value on record (Eurostat).

At the same time, the EU is the second largest market in the world for pharmaceuticals. The EU’s total pharmaceutical spending was around €230 billion in 2021 or 1,5% of the EU GDP, according to IQVIA MIDAS database.

14. When can we expect this new legislation to be in place?

The proposal will now be discussed by the Parliament and the Council. The discussions will start as soon as possible, but we cannot predict the timing for adoption at this stage.

For more information:

EU Action on Antimicrobial Resistance

Press release

Questions and Answers on the Recommendation on Antimicrobial Resistance (AMR)

Factsheet on putting patients in the centre

Factsheet on driving innovation for pharmaceutical industry

Factsheet on tackling antimicrobial resistance

Pharmaceutical Strategy for Europe

1 A regulatory sandbox can under certain conditions be linked to an adapted framework, tailored to the characteristics or methods inherent to certain, especially novel medicines, without lowering the high standards of quality, safety, and efficacy.

Source – EU Commission

 

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