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Romania to negotiate for the first time, at European level, new regulations on patient access to treatments for rare and pediatric diseases

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According to national and European experts, access to innovative medicines for Romanian patients suffering from rare diseases can be improved in the coming years, as Romania has for the first time the chance, as a member state of the European Union, to contribute to the revision of the Orphan Medicinal Regulation, which was implemented 20 years ago.

National authorities, European decision-makers, representatives of the pharmaceutical industry responded to the initiative launched by the Media Platform www.caleaeuropeana.ro and the Romanian Association of International Pharmaceutical Manufacturers (ARPIM) and held an open dialogue on the access of Romanian patients to orphan and paediatric medicines, as well as on Romania’s role in the forthcoming negotiations at European level for the revision of the Orphan Medicinal Products Regulation.

To ensure that patients suffering from rare diseases have access to medication, the “Regulation on Orphan Medicinal Products (OMP)” was adopted 20 years ago, introducing specific legislation, a definition of OMP, and a specific committee responsible for OMP at the European Medicines Agency (EMA), as well as incentives to promote the development of treatments for rare diseases.

Read also: Romania has one of the worst performances in the EU when it comes to access to treatments for rare diseases

The role of Romania and Romanian experts in the negotiations held by the European institutions

This more than 20-year-old regulation will be re-evaluated, and this is the first time when Romania, as an EU Member State, will participate in the legislative process in the negotiations at the Council level and subsequently in the negotiations between Council and Parliament by submitting successive positions in the negotiations on the legislative act, according to national interests in the matter.

The review of EU legislation addresses the gaps identified by the evaluation with regard to products and their development for the specific needs of children and patients with rare diseases; early access to treatment for these groups and improvement of approval procedures and reduction of inequalities in access.

The European Commission launched another public consultation on 28 September, which will close on 21 December 2021, on the reform of the overall medicines policy framework as part of the resilience of the EU pharmaceutical sector. Thus, the Permanent Representation of Romania to the EU invites key stakeholders in Romania to participate and get involved and, most importantly, make their voices heard at European level.

What happens after the European Commission presents the legislation

Once the European Commission presents the legislative act to the public, the EU Council and the Parliament will start debating it (co-decision). The French Presidency, which will be at the helm of the Council in the first half of next year, will put the proposal on the agenda with a view to finding a compromise with a qualified majority of the EU 27, and the Parliament in parallel will vote on its position at first reading, initially in the ENVI committee and then in the plenary of the European Parliament.

When the Council reaches an agreement it will start negotiations with the European Parliament, the so-called trilogues, and after several rounds of negotiations, a political agreement will be reached between the two co-legislators. Once agreement is reached, the regulation will be adopted and will enter into force immediately after publication in the Official Journal of the EU with immediate legal effect, provided there are no transitional periods and it is a regulation and not a directive. From the moment the public consultation is closed until the publication of the act, Member States, the Council and the Parliament cannot influence the legislative act, as it is pending and in preparation for adoption by the Commission.

Romania will, for the first time, participate in the legislative process in the negotiations at the Council level and subsequently in the negotiations between the Council and Parliament by submitting successive positions in the negotiations on the legislative act, depending on national interests in the matter.

Negotiations between the Member States at Council level take place between the Member States at three levels: at technical level, by Member States’ experts in the working groups on pharmaceuticals and medical devices; at the level of the Permanent Representatives of the Member States and at ministerial level, the EPSCO Council (health component).

In addition to participating in public consultations, Romania will have a new opportunity to participate, contribute and influence the EU legislative process in order to create optimal conditions for ensuring access to treatment for rare and pediatric diseases for the benefit of Romanian patients and to create the incentive framework necessary for the development of orphan and pediatric products for the pharmaceutical industry.

Romania will also contribute to the initiative “a European Pharmaceutical Strategy” and will support ensuring the availability of innovative and affordable medicines for patients, as well as supporting the competitiveness, innovation capacity and sustainability of the pharmaceutical industry in Romania and in the European Union.

Diana Zaim este foto jurnalist, câștigătoare a Premiul Publicului la European Youth Event 2020, cel mai mare eveniment pentru tineri organizat de Parlamentul European. Absolventă a secției germană-portugheză în cadrul Universității din București, Diana urmează în prezent programul de master ”Relații Internaționale și Integrare Europeană” în cadrul SNSPA. Pasionată de promovarea valorilor europene, Diana este parte a comunității Model European Union, cea mai amplă simulare la nivel european a procesului decizional din cadrul Uniunii Europene.

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MEP Vasile Blaga supports a fair green transition for Romania: Gas and nuclear energy must be considered transitory

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© Vasile Blaga / Facebook

MEP Vasile Blaga (PNL, EPP) reaffirms his support for a fair green transition for Romania, in which gas and nuclear energy are accepted in order to achieve the objectives set by the European Ecological Pact.

The European Parliament hosted yesterday, 30 May, a public hearing whose guests were several experts who debated, together with members of the two committees ECON and ENVI, the inclusion of gas and nuclear energy in the taxonomy of the European Union. Many of the opinions expressed push the debate towards a rejection of the European Commission’s proposal of March whereby nuclear energy and gas are considered, under certain conditions, green.

I reaffirm my support for the version proposed by the European Commission. There are many reasons why gas and nuclear energy should be considered transitional in order to achieve the objectives set by the European Green Pact. One of the reasons, and perhaps the most important one, relates to the realities on the ground in each Member State. France has a significant share of nuclear power, just as Germany is heavily dependent on gas. The decisions that the European Union needs to implement in order to achieve the objectives – already set and agreed by all Member States – need to be balanced first and foremost”, EPP MEP Vasile Blaga told European Way.

“Countries like Romania or Poland need a realistic transition towards the targets set by the Green Pact. Cohesion and solidarity in the European Union means that each Member State must take into account the other and, as a whole, decisions must not ignore any reality, be it further West or further East”, added the EPP MEP.

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MEP Vasile Blaga: “New sanctions package against Russia is a strong sign of EU solidarity with Ukraine”

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MEP Vasile Blaga (PNL, EPP) welcomes the agreement reached by EU leaders on the latest sanctions package against Russia.

“The progressive embargo agreed yesterday evening by the European Council is a consistent step towards blocking the financing of the war unleashed by the Russian Federation in Ukraine. The sanctions will initially target 75% of imports of crude oil and petroleum products, rising to 90% by the end of the year”, the MEP told caleaeuropeana.ro.

According to the liberal MEP, the Council’s decision puts an end to a fundamentally unacceptable situation – condemning Russian aggression in Ukraine while financing it through hydrocarbon imports into the EU: “This is a necessary step in the attempt to force the Russian Federation to stop the absurd war in Ukraine. Of course, there will be voices saying that the 10% represents hesitation, failure or lack of solidarity. I place them squarely in line with those propagating pro-Russian rhetoric. The European Union also has a degree of heterogeneity, especially in terms of the degree to which economies are dependent on Russian hydrocarbons. In this context, blocking 90% of imports at the end of the year is undoubtedly a victory that I welcome”, said EPP MEP Vasile Blaga.

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MEP Vasile Blaga: The most effective weapon against Russia’s blackmail to turn off the gas tap is EU solidarity

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© Vasile Blaga/Facebook

The cut-off of gas supplies to Poland and Bulgaria should be the start of the EU finding solutions to disconnect Europe from the Russian Federation, said MEP Vasile Blaga (PNL, EPP).

The MEP stressed that the most effective weapon against Russia’s blackmail to turn off the “gas tap” is EU solidarity.

“A generalised and overnight disconnection of Europe from Russian resources is not realistic, but in the medium and long term it is the only solution. The dependence of large EU economies – such as Germany’s – is a major obstacle to this necessary disconnection, but a united reaction, comparable to that during the pandemic, can provide the solutions to get out of this situation, which is immoral to say the least”, said the liberal MEP for the CaleaEuropeana.ro.

According to the MEP, it is necessary, as a first step, even if only in principle, for all EU Member States to speak “with one voice” on eliminating energy dependence on Russia.

“It is obvious that the European democratic architecture is incompatible with the immoral paradox of financing Russia’s war machine in the context of military aggression against the sovereign state of Ukraine. Then, without delay, we need to take concrete steps that will bring us within a reasonable timeframe closer to this priority objective”, added the EPP MEP.

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