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EPP MEP Pernille Weiss highlights Romania’s potential to attract investment in pharmaceuticals by creating a favourable environment for innovators and SMEs

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In an intervention at the recent ARPIM event, “The health of Romanians between hopes, challenges, investments, and innovation: a European vision,” Danish Member of the European Parliament (MEP, EPP) Pernille Weiss, who serves as the rapporteur for the Pharmaceutical Directive, addressed the crucial role of the ”Pharma” package in shaping the future of pharmaceutical innovation in the European Union (EU).

Weiss emphasized the significance of the Pharmaceutical Directive within the broader ”Pharma” package, underscoring the need for a common shared language and toolbox to navigate the legislative landscape effectively. She articulated the anticipation within the European Parliament and numerous member states for the European Commission’s proposal, expressing hope that it would propel the EU toward becoming a ”global hub for pharmaceutical innovation”.

As the rapporteur for the Pharma Directive, Weiss outlined her vision for the legislation, placing a strong emphasis on promoting innovation while ensuring patient access to medicines. Drawing on her background as a nurse and a lineage of healthcare professionals, Weiss envisioned the European Union as a community of lawmakers, healthcare systems, universities, and education institutions working together to make the EU ”the most attractive place on earth for not only pharma industries, an important part of our industries but also the adjacent industries that as a total system can be labeled as the life science industries”.

Weiss highlighted the two central components of the ”Pharma package”—the directive and the regulation. She emphasized the lengthy wait for the Commission’s proposal and the collective aspiration for it to enhance the EU’s ability to foster pharmaceutical innovation, provide access to medicines, and strike a balance between affordability and rewarding innovation.

The MEP expressed her hope of making the EU the first choice for the pharmaceutical sector in terms of production, research and development facilities, and collaboration opportunities. Weiss acknowledged the pivotal role of small and medium-sized enterprises (SMEs) as ”the backbone of innovation” in Europe’s pharmaceutical landscape and stressed the importance of legislation tailored to accommodate their unique needs.

Weiss proposed a nuanced approach to data protection, advocating for predictability, fairness, and alignment with global standards. She challenged the Commission’s concept of tying data protection to product launches in individual member states, emphasizing the need for a more comprehensive and fair negotiation position.

In particular, Weiss highlighted the potential for countries like Romania to attract pharmaceutical investments by creating a conducive environment for SMEs. She called for a streamlined process for innovators and entrepreneurs, ensuring that directives and regulations support their efforts and contribute to a faster, more efficient pathway for market authorization and pricing agreements. In this sense, the Danis MEP proposed an application model for pricing and reimbursement in member states expressing interest in specific medicines. This, she argued, would facilitate faster access for citizens and incentivize innovative companies, especially SMEs, to invest in countries like Romania.

As the European Parliament moves towards interinstitutional negotiations with the Council, Weiss expressed her hope for an agreement before the European elections in June next year. She concluded by emphasizing the need for a legislative package that not only meets high expectations but also reflects the true interconnections between the diverse elements of pharmaceutical innovation. Her proposed legislative adjustments aim to ensure that Europe remains a global leader in pharmaceutical innovation, delivering timely and affordable solutions to citizens across member states, regardless of their size or economic status.


Pernille Weiss MEP (since 2019) is a politician from the Conservative People’s Party of Denmark. Hereby she is a Member of the Group of the European People’s Party in the European Parliament (EPP Group).

Ms Weiss is a Member of the Committee on Industry, Research & Energy Committee and of the Committee on the Environment, Public Health and Food Safety. She is also a Substitute Member of the Committee on Women’s Rights and Gender Equality.

Prior to being an MEP, Ms Weiss served eight years as a County Council Member. She holds several degrees: she is a nurse (RN), has a Master’s of Science (health), is a certified sexologist and holds a Master’s Degree in Innovation and Leadership (LAICS). She is an acknowledged Nordic expert in architecture and health. Ms Weiss has been a Board Member of SME Europe 2019.

She was Head Manager in the public healthcare sector and the building consultancy industry before establishing her own consultancy firm in 2008.

 

Alexandra Loy este redactor și specialistă în afaceri europene. Deține un doctorat în domeniul științe politice, dobândit în anul 2018, cu tema analizării impactului președinției României la Consiliul Uniunii Europene asupra sistemului național de coordonare a afacerilor europene. Alexandra este membru al comunității academice din cadrul Școlii Naționale de Studii Politice și Administrative.

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Marcel Ciolacu underlines the importance of the European elections on 9 June: I want to live in a free Romania and a free Europe. These elections will be about principles, defending values, and the rule of law

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During the event “Living better with Europe” at the Palace of Parliament, Prime Minister Marcel Ciolacu expressed his desire to live in a free Romania and Europe.

Stressing the importance of the 9 June elections throughout Europe, he pointed to the need for dialogue between the major European families to defend democracy. Ciolacu said that his government was striving to implement social democratic values in Romania and to represent the specificity of the country within the European Union.

The Prime Minister also discussed the economic and social challenges facing Europe, stressing the importance of finding the best solutions to defend the European economy and national economies. He highlighted the changes in European political philosophy, stressing that priorities have adapted to the new demands.

Ciolacu also spoke about the importance of Romania’s membership in the European Union and NATO for the country’s security and prosperity, mentioning the important contribution of European funds to Romania’s development.

The Prime Minister highlighted Romania’s efforts in supporting the Republic of Moldova and President Maia Sandu in the European path of the neighbouring country. He also stressed the importance of a strong social democratic party in Moldova.

Finally, Marcel Ciolacu stressed that the upcoming elections will be about principles, defending values and the rule of law, but also about the economy, expressing his confidence that Europe mainly needs social democracy at this time.

The “Living Better with Europe” event, held at the Palace of Parliament, under the auspices of PSD and PES activists Romania, hosted leading figures from the European social democratic family such as Iratxe García Pérez, the chair of the S&D Group in the European Parliament, and the group’s vice-chair Gabriele Bischoff.

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INTERVIEW Mathieu Michel, Belgian Gov State Secretary: For competitiveness in EU, it’s time to slow down regulation and speed up enforcement and implementation

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@ European Union 2022

The time has come for the European Union to slow down regulation and speed up the application and implementation of digitisation legislation in order to be competitive, said Mathieu Michel, State Secretary for Digitisation in the government of Belgium, the country holding the six-month presidency of the Council of the European Union, in an interview with CaleaEuropeană.ro.

“The network is made up of a lot of industries, companies, but also SMEs, and the best way to help them exercise the capacity of their business model is to help them have a real, single market when it comes to implementation. The first thing would be to build common governance,” Michel said.

He cited the example of EU legislation on Artificial Intelligence, saying that the European Union wants to avoid 27 different national interpretations of AI, especially as the ethics and liability issues around the use of AI will be linked to the relationship with companies and SMEs.

“What the industry wants is simplification of regulation, if you look, for example, at the AI law. (…) This is very important because if you look at big companies like Meta, Google and so on, they have lots of lawyers who can accompany these companies through the European regulation. think the competitiveness relies on smaller SMEs of today and the way they will be able to have an easy life in deploying their business model. That’s why it’s not the regulation that’s the problem, it’s how we implement it,” explained the Belgian state secretary, as the Belgian presidency of the EU Council tasked former Italian prime minister Enrico Letta with drafting a report to boost the European single market and boost EU competitiveness.

Speaking also about the future of the telecoms industry in the context of an expected communication from the European Commission, Mathieu Michel raised the importance of cyber security. “A common shield” he said, adding that the cyber resilience law is linked to telecoms.

Full interview:

CaleaEuropeană.ro: You are one of the responsible from the Belgian Presidency of the EU Council for digital Europe, for moving forward Europe as a technological actor and also in the industry of digital and telecom. On the digital transformation of Europe can you elaborate a bit what are the key priorities of the Belgium presidency when it comes to us digital transformation?

Mathieu Michel: There’s been an evolution of regulation, which came for the actors of digitization: DSA, DMA, GDPR. A first message connected to all that with those regulations is to say: it’s time to slow down regulation and speed up enforcement and implementation of those regulation. For example GDPR. The way we implemented GDPR all across Europe, through the 27 member states was a little bit like silos and we think it’s time to build a common governance, a more coherent implementation of the regulation. That’s why our first message would be let’s slow down regulation and let’s speed up implementation. It’s deeply connected to competitiveness. Your web is composed with a lot of industries, companies, but also SMEs and the best way to help them to unleash the ability or the opportunity with their business model is to help them to have a real single market when it comes to implementation. And so the first part would be let’s build a common governance. It’s a little bit like the same if we speak about the AI.  We just ended the the discussion about the AI Act. The way we will enforce the AI will be really important, and we need to take the challenge on a unique single owner. Let’s slow down regulation and speed up implementation. That’s something very important.

CaleaEuropeană.ro: You touched on some ideas and now I want to go through each slice of it. Since you mentioned the Artificial Intelligence Act, which we all know that is the first of its kind in Europe and now you are practically continuing, based on the Spanish presidency legacy’ of this act. How do you plan to facilitate or contribute within your presidency, to develop a comprehensive as a framework for AI in terms of ethics, but also in in terms of transparency and accountability?

Mathieu Michel: We need to establish the AI mission. Who will be seated in the AI office, will be really important. An important contribution of Belgium for the last weeks, was to bring a discussion about definition that were in the AI act. The AI Office will be the authority which will accompany the implementation of the AI act. That’s something very important. If you look at the GDPR, the GDPR was foreseen in GPR that each countries had to deploy a Data Protection Authority. It means that alongside to GDPR, you have 27 different data protection authority. It means 27 different interpretation of the GDPR. That’s completely what we want to avoid with the AI act, not having breaches when deploying AI in Romania, in Italy or in France. It has to be confronted to the same interpretation of the text. And that’s where the AI office is really important. You spoke about ethics, accountability, how do we define it? How we ask reporting to the SMEs? It must be a simple way for them to report what they are doing. In that role, I think the AI office will have an important role to play: to avoid that those silo in terms of the interpretation or implementation.

CaleaEuropeană.ro: One of the flagships of your presidency will be competitiveness. It is also a part of the future EU Strategic Agenda that the leaders will set up within the Belgium Presidency , and you’re about to present a report commissioned by the Belgian Presidency through former Italian Prime Minister. How do you plan to foster innovation and competitiveness? You also mentioned speeding up implementation while reducing or not putting forward regulation. How do you see the relation with the industry in this part?

Mathieu Michel: I think what the industry wants is to simplify the line, if you look, for example, at the AI act. In Belgium we have a strong health ecosystem. For example, in terms of medical devices, there is already a lot of regulation on medical devices using artificial intelligence. It will be important to negotiate reporting. They’re saying, „okay for regulation, but please, make it simple to enforce”. Make it simple to implement in our line of daily life. That’s really important because if you look at big companies like Meta, Google and so on, they have armies of lawyers that can accompany those companies through the European regulation. I think the competitiveness relies on smaller SMEs of today and the way they will be able to have an easy life in deploying their business model. That’s why regulation is not the problem is the way we implement regulation. For the future, I think that there is a good balance that we must find, between innovation and twist. If you look at AI, that’s innovation, but we must be post worthy AI. 

CaleaEuropeană.ro: Can you give us some insights about this? From the public opinion view, it mirrors with what the Commission is doing with Mario Draghi report on the single market. We also had the annual Single Market Report, and this one with the competitiveness. They will be complementary?  What do you think that this report, the one Commissioned by the Belgian presidency will bring forward?

Mathieu Michel: The report that we will receive will show us the past to better accompany the competitiveness of our industries. If I take the example of the GDPR, the GDPR is a good regulation. But its implementation is done like silos. The way enforced for example, a company the regulation of GDPR is not the same as the Data Protection Authority in Belgium. For a SME, which deploys business model in force in Belgium, it will have two different way to deploy and switch its project and that’s not helping the competitiveness of your work. That’s the reason when we speak about regulation, and speed up it’s making for the companies that a more coherent way to implement the regulation. In terms of everything, but specifically on digitalization, artificial intelligence, and the way we can deploy and help our SMEs to deploy the creativity. That’s really important to understand. We live in a global competition all around the world. The way we will put more and more regulation in the bank for companies and SMEs, it won’t help them to be competitive. We will find the correct balance between letting them deploy the innovation and building trust through a strong governance. That’s why the AI office is not there to say to the SMEs: „okay, do what you want?”. It’s there to say: „we will help you to deploy your creativity”.

CaleaEuropeană.ro: Practically, you say that the attraction force for SMEs and for companies will be this balance between speed up implementation and simplifying regulation?

Mathieu Michel: If you want to implement in 27 different countries with 27 different strategies, it makes the life of SMEs more complex.  That’s a point. You can’t imagine 27 Data Protection Authority in Europe. So that’s the way we need to go.

CaleaEuropeană.ro: One thing also that is important that we want to touch upon is the fact that the European Commission will present a Communication for the future of the telecom industry, which is related to competitiveness and also is related to digital, to technology, to cybersecurity, as well. What is the engagement of the Belgium presidency for the future of the telecom industry and how do you see it in terms of regulation but also speeding up greater connectivity across the European Union?

Mathieu Michel: I can tell you there is two things that are really important about cybersecurity. The first one is the implementation of this tool. That’s really something important. I think, what will build a common protection shields on Europe needs to and so there is a technical definition that must come about disable security schemes, which may be really important to protect you or all the actors in EU. If you speak about cybersecurity, we must protect everyone: hospitals, SMEs, nuclear reactors, but also defense. So we have to prove that we can. The Cyber resilience act is more connected to telecommunication because it’s the way we build our hardware and the way our world is protected against cyber security threats. So those are two important files that we will have to follow.

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Interview| Minister Bogdan Ivan: Romania supports public-private partnerships as a tool to accelerate innovation and economic growth and promotes dialogue between the public and private sectors in key areas

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Romania supports public-private partnerships as a tool to accelerate innovation and economic growth and promotes dialogue between the public and private sectors in key areas such as technology or infrastructure, underlined the Minister for Research, Innovation and Digitalization, Bogdan Ivan, in a wide-ranging interview for CaleaEuropeană.ro on Romania’s actions and positions on the big digital and technology dossiers at European level such as the Interoperable Europe Act, the future of European competitiveness, cyber security and the future of the telecommunications industry.

Interoperable Europe. Romania’s vision and commitment

In his view, companies play a key role as ”providers of the technology that the administration wants to use to modernise Romania”.

So ”the state and the private sector can only evolve together for the modernisation of Romania”, Ivan replied to a question about the role private companies could play in innovation in the context of the Interoperable Europe Act.

The Romanian official also described the act as ”the European interoperability platform – this act is a Schengen agreement in IT, where borders disappear and technological solutions circulate freely in Europe”.

”This cross-border approach is even more relevant in cybersecurity because cyberspace has no borders and cyber attacks do not require visas. The Interoperable Europe Act targets both the public and private sectors: annual cost savings as a result of achieving cross-border interoperability range from €5.5 to €6.3 million for citizens and €5.7 to €19.2 billion for businesses, according to the European Commission. The forecast for business is that it could save up to 30 billion working hours per year. But the main benefits of the Act are for European citizens. Citizens could save up to 24 million hours (lost in queues and traffic) every year. Public institutions at local, regional and national level will have improved IT systems and administrative processes, so they will offer more efficient and accessible services to citizens. Interoperability will make it easier for EU Member States to work together across borders,” explained the Minister for Research, Innovation and Digitalization.

Bogdan Ivan added that ”the Act will promote a more favorable framework for public-private partnerships through a more efficient exchange of resources, expertise and technologies between the public and private sectors, with direct benefits in the development and implementation of innovative technological solutions in public administration”.

Asked about the measures adopted by our country to digitalize and improve the efficiency of public services through public administration modernisation projects, the Romanian official mentioned the NRRP projects, worth €6 billion, which have a final implementation deadline of 2026.

He also listed the main projects underway: the government cloud and the National Interoperability Platform.

”It is a paradigm shift for the way the citizen interacts with the administration and it is an internal revolution, of the administration itself. We already have an architecture in place for the future digital administration: Romania has an e-government strategy, a road-map with clear targets. We are working on a National Catalogue of Public Services in the central administration – in this catalogue, of the almost 3000 services inventoried, more than 50% are already digitized or partially digitized. We have the legal framework for big, decisive reform projects – the government cloud, interoperability: I personally participated in the drafting of the Interoperability Law and I know how relevant the impact of this law is for the efficient functioning of the Romanian state and for the well-being of every single Romanian”, said Ivan.

Competitiveness in Europe. Romania supports public-private partnerships to accelerate innovation and growth

Switching to another facet of the European Union, the competitive one, the Minister for Research, Innovation and Digitalization stressed that, in terms of regulation, ”Romania is balancing the need to ensure a robust regulatory framework that protects citizens with the need to maintain a flexible and innovative business environment”.

In his view, ”smart regulation is needed, which does not unnecessarily burden the private sector, but ensures compliance with a coherent legal framework and the protection of citizens’ data”.

”In the EU debates, Romania can contribute with proposals that reflect its national interests, but also those of the EU as a whole: promoting cohesion policy and supporting sustainable economic growth. We actively promote policies that encourage innovation and competitiveness, including through investments in digital education, research and development and innovation, and thus contribute to increasing the competitiveness of the Romanian economy, but also of the EU as a whole, on the global stage”, elaborated Bogdan Ivan.

Romania’s approach to the future of the telecom industry in Europe

In order to achieve the ambitious goals of the Digital Decade, as well as those of the European Green Deal, Romania has elevated connectivity to the status of a strategic sector.

”Rapid technological progress in priority areas for the EU, such as Cloud, Edge, AI, 5G, implies major investments in developing a high-performance and sustainable digital infrastructure, but also in strengthening cyber security. In addition, investments are needed in network capacity, implementation of next generation infrastructures, access to large amounts of reliable data, computing resources”, detailed Bogdan Ivan.

In addition, he stressed that “an integrated European approach could improve coverage across national border areas and support the EU in cases of harmful interference by third countries at external borders”.

”Removing obstacles, in particular diverse and difficult sectoral regulations, can facilitate the strengthening of cross-border cooperation. We have concrete, permanent contacts with the institutions at European level, we collaborate excellently with the competent institutions in Romania and we coordinate in defining Romania’s strategic objectives and in the tactical implementation of practical measures”, the Romanian official believes.

On how Romania is addressing the challenges of European regulation in the context of rapidly evolving technology, Bogdan Ivan said that ”for the Romanian Government, digital transformation is a country project”.

”Legislation must reflect the evolution of technology and European principles, which put the citizen at the centre and shape Europe as a global player with a decisive role in the promotion and development of technology,” says the Minister.

Cybersecurity: ”A strengthened cybersecurity legislation in Romania is an imperative for the digital systems of public institutions”

And because the digitalization of public institutions cannot be possible without cybersecurity, ”cybersecurity cooperation is not a luxury but a necessity in our digital age”, said Bogdan Ivan.

He called for ”a clear legislative framework, with short deadlines, which would provide a basis for rapid and effective action by the relevant institutions”.

”We have a National Cyber Strategy, which we updated on 31 January. We have strong institutions protecting our critical infrastructure. We have dedicated experts working tirelessly to counter cyber threats. IT experts recommend cloud solutions for public data infrastructure – these are considered to be the best protected against cyber threats. Romania has chosen the safest solution for cyber security – the government cloud. This 3rd millennium infrastructure helps to increase the security of Romania, located at the border of the EU and NATO. The government cloud is, according to our world-renowned cyber experts, Romania’s next line of defence”, he concluded.

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