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The European Commission has published its long awaited (and delayed) proposals for a substantial revision of the EU regulation on Supplementary Protection Certificates (SPCs), which wraps up a series of various legislative scenarios suggested in the past years in favour of the recasting of the SPC regulations towards a more centralised system.

As already recalled in a previous article, the SPC system as it stands is based on a mix of national and European legislations. While the substantial conditions for the grant of an SPC are common to all EU Member States, based on European Regulation (EC) 496/2009 of 6 May 2009 for medicinal products and Regulation (EC) 1610/96 for plant protection products, SPC applications are filed with the national patent office of each Member State and have a national territorial effect, similar to the national designations of a European Patent.

With the Unitary Patent system and the UPC about to enter into force, it was time for the EU to think about a similar unified system for SPCs. As it stands, the relevant EU Regulations 1257/2013 and 1260/2012 do not provide for a unitary SPC but merely offer European patent holders (for which the basic patents would not have been opted-out) the opportunity to have the relevant national SPCs litigated before the UPC (which will then be mandatory for any SPC granted on the basis of a unitary patent). However, the grant procedure for such SPCs and their effects would still remain at the local level.

Several propositions had been submitted between 2018 and 2022 to consider a legislative review of the SPC system.

The European Commission itself first highlighted in 20181 the necessity to think through a revised SPC system in light of the fragmentation of the case-law with a consequential lack of legal certainty for the stakeholders, as well as a multiplication of proceedings which represent significant costs for the SPC holders.

The European Commission reiterated its criticism of the fragmentation and lack of transparency of the actual SPC system in its evaluation of the SPC Regulation published on 25 November 2020, together with the European Commissions IP Action Plan. This led the European Parliament in November 2021 to adopt a resolution on the European Commissions IP Action Plan which supports the implementation of a unified SPC system and called on the European Commission and the Member States to take the relevant measures.

A centralised SPC system was also suggested in the European Commissions call for evidence for an impact assessment on proposals for a unitary SPC and/or a unified procedure for granting national SPCs, published on 8 March 2022, with the aim of adopting a proposal for a revised legislation by the end of 2022. Several models were also suggested by the Max Planck Institute in a second study published by the European Commission in September 2022, with a proper unitary SPC system however identified as the least preferred route in light of the uncertainties at the time surrounding the implementation of the unitary patent package.

These various suggestions eventually led the European Commission to publish today two different proposals for a revision of the SPC Regulation: a proposed brand new Regulation creating a unitary SPC and a recast of the current SPC Regulations for medicinal products and plant protection products to include a centralised examination procedure for some SPCs.

The first set of proposals from the European Commission consist of introducing a centralised procedure for the grant of national SPCs, in line with the suggestions introduced in the Max Plank study of September 2022. Such a centralised procedure is described in a recast of the current SPC regulations on medicinal products (Regulation (EC) 469/2009) and plant protection products (Regulation (EC) 1610/96).

The aim would be to enable holders of European patents and centrally authorised medicinal products to file a single SPC application which will be examined through a centralised examination procedure and enable the simultaneous grant of national SPCs in all the EU Member States designated in the application. The central authority in charge of the examination would be the EUIPO, which would issue a binding opinion to the attention of the national IP offices of each Member State which will then grant or refuse the application (in accordance with their national formal rules). The relevant SPCs would have a national effect like current SPCs.

During the examination procedure, after assessing the formal admissibility of the SPC application, the EUIPO will entrust the substantive examination to a panel made of a member of the EUIPO and two SPC-qualified examiners drawn from two different national IP offices in the Member States.

Of note, the SPC applicant who would receive a negative opinion from the EUIPO panel can file an appeal before the Boards of Appeal of the EUIPO. Further appeals can be filed before the General Court and ultimately before the CJEU (for legal review).

As also suggested from the study of the Max Plank institute, third parties (such as generic companies or Member States) will be able to file third party observations during the examination of the centralised SPC application (within 3 months as from the publication of the SPC application) and file opposition briefs to challenge the validity of the SPC with a centralised effect (within 2 months after the publication of the examination opinion from the EUIPO panel).

The centralised procedure is however restricted to SPCs based on centrally authorised medicinal products, and expressly exclude national MAs (including those granted in the context of a decentralised procedure or a mutual recognition procedure). SPC applicants fulfilling the conditions to apply through the centralised procedure will be obliged to follow to this new procedure. Any SPC application filed with a national IP office while the conditions for using the centralised procedure are met shall be rejected by that national office.

National IP offices will thus remain competent to grant national SPCs based on national MAs (including MAs granted under the decentralised procedure and mutual recognition procedure).

The conditions for grant as provided for under the current SPC Regulation (under Article 3) remain unchanged, and the relevant CJEU case-law remains applicable. However, the European Commission noted the discrepancies amongst the Member States on the duration of European patents and thus on the starting date of SPCs (up to a one-day difference), and consequently suggested to clarify that rule at least for unitary SPCs.

The proposed Regulations also suggests to amend Regulation (EC) 1901/2006 to enable the application for SPC paediatric extensions through the centralised procedure (for national and unitary SPCs).

In its second set of regulations, the European Commission also suggests the parallel implementation of a unitary SPC, which would be applied for on the basis of European patents with a unitary effect (unitary patents). Such a new system is described in the proposal for a New Regulation for SPCs on medicinal products and plant protection products.

For such SPC application, the new centralised procedure described above also applies. The opinion of the EUIPO panel will thus lead to the grant of a unitary SPC with a uniform effect in all the EU Member States in which the basic patent has unitary effect (17 States to date).

Of note, holders of a European patent with a unitary effect will be able to file a combined application' with a view to the grant of both a unitary SPC (which would have effect in the 17 Member States which have ratified the UPCA) and national SPC for additional Member States not covered by the unitary patent.

The new Regulation would thus be fully aligned with Regulation 1257/2012 and the UPCA, and unitary SPCs would be litigated in the UPC just like their basic patents. It is expected that the UPCA will be amended to include unitary SPCs in its scope.

After the grant of a unitary SPC, third parties will also be able to challenge the validity of the SPC by initiating an action for a declaration of invalidity before the EUIPO. Related decisions can also be appealed to the Boards of Appeal and eventually to the General Court. The Proposals also address the interplay with counterclaims for a declaration of invalidity that could be brought against a unitary SPC before the competent court (including the UPC provided that the UPCA is amended accordingly).

In line with its IP Action Plan, the European Commission expects the implementation of the four proposals to tackle the remaining fragmentation of the EUs IP system, and improve transparency and legal certainty by notably providing for a more consistent case-law on SPCs.

The Proposals also suggest to implement a central database with the EUIPO which would gather all the data collected and stored by the office from applicants and third parties (e.g. third party observations).

This improved harmonisation mostly aims at hastening generic/biosimilar entry by facilitating their information on the current SPC protection across the EU and planning their product launches.

The Proposals are also expected to involve cost reductions for SPC applicants, with estimated savings of 137,000 EUR for a 5-year protection in all 27 EU Member States.

In terms of next steps, the proposed Regulations will now be discussed by the European Parliament and the Council of the European Union in view of their potential adoption and entry into force.

1 As resulting from a Summary of the replies to the public consultation on SPCs and patent research exemption, a Study on the legal aspects of Supplementary Protection Certificates in the EU written by the Max Plank Institute, and a Study on the economic impact of supplementary protection certificates, pharmaceutical incentives and rewards in Europe

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European Union to implement a unitary SPC and centralised ... - JD Supra

Ambassador of the European Union on Georgias membership

EU Ambassador to Georgia Pavel Gerchinsky says that the EU wants to give Georgia the opportunity to join, however, Georgia itself decides whether the country wants to be a member of the EU or not.

Whatever decision Georgia makes, we in the European Union respect it. We understand that 89 percent of Georgians support European integration and EU membership. This is a historically high figure, says Gerchinsky.

He hopes that the process of Georgias accession to the European Union will be successfully completed. According to him, this is a long and complex process that all countries have gone through to join the European Union:

I also know that European integration is included in the Georgian constitution. We are here to help you, work with you and make sure the Georgian government has the support it needs to make that dream come true. However, it is now up to the Georgians to move this stone, and I hope that this process will continue and successfully culminate in Georgias membership in the European Union. It will be a long and difficult process. This is the path followed by all the countries that wanted to join the European Union. However, everything is in the hands of the Georgian political elite.

Lets hope there is enough progress on reforms for the 27 member states to take the next step towards Georgias membership in the European Union, a candidate status that Georgia could have achieved in December. However, I repeat, this will depend on the progress that Georgia makes on the path of reforms, he said.

On June 17, 2022, the European Commission prepared a conclusion re granting Georgia, Ukraine and Moldova candidate status for EU membership. As a result, Ukraine and Moldova will receive EU candidate status and will be required to fulfill certain obligations, while Georgia will first be obliged to fulfill the 12-point plan and conditions, and then get a chance to receive the candidate status.

On November 8, 2022, the European Parliamentarians discussed the annual report on the implementation of the Association Agreement between Georgia and the European Union at a meeting of the Foreign Affairs Committee in Brussels. According to the adopted compromise document, Bidzina Ivanishvili is no longer mentioned as an oligarch, however, in the chapter on deoligarchization, his name and surname are indicated and it is written that it is necessary to take, among other things, legislative decisions regarding Ivanishvilis excessive influence.

On February 3 this year, the European Commission published a report on Georgia, Ukraine and Moldovas compliance with EU legislation and assessed Georgias compliance with EU foreign policy as moderately prepared.

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Ambassador of the European Union on Georgia's membership - JAMnews

The European Union has a plan to decarbonize aviation over the coming decades.

The European Union reached a provisional agreement on Tuesday aiming to decarbonize air travel and create a level playing field for sustainable aviation fuels (SAFs).

The ReFuelEU Aviation proposal aims to put Europes air travel industry on a trajectory to meet the E.U.s climate targets for 2030 and 2050. Adina Vlean, the European Commissioner for Transport, called the agreement a turning point for European aviation.

Before becoming law, the agreement must be approved by individual E.U. member countries, but that is viewed as a formality.

Once adopted, the law will require airlines to use fuel that blends sustainable aviation fuels (SAF) with kerosene in progressively larger amounts, beginning at 2% of the total fuel in 2025, rising to 6% by 2030 and to 70% by 2050.

The plan is for the quotas to help spur both the demand for and supply of SAFs, which will in turn bring costs down. Until now, the development of SAFs has been hindered by low supply and prices that are still considerably higher than fossil fuels.

E.U. officials are touting ReFuelEU Aviation as a win-win for both the environment and the economy. Shifting to sustainable aviation fuels will improve our energy security, while reducing reliance on fossil fuel imports, said Vlean. These kinds of measures help make Europe a front-runner in the production of innovative clean fuels, globally. We estimate that the SAF market will create more than 200,000 additional jobs in the EU, mainly in the renewables sector.

Since 2021, the E.U. and U.S. have agreed to achieve net zero carbon emissions by 2050. But their approaches have been different.

In early September 2021, the Biden administration announced a new sustainable aviation fuel goal to increase the production of SAF to at least three billion gallons per year by 2030.

The plan includes an SAF tax credit and the launch of a new SAF Grand Challenge to ramp up domestic production of SAFs with a roadmap devised holistically by an interagency team that includes the departments of energy, transportation and agriculture as well as stakeholders from national labs, universities, non-governmental organizations, and the aviation, agricultural, and energy industries.

On Wednesday, the International Air Transport Association (IATA), the global airline lobby, expressed reservations about the mandate-driven approach outlined in the European plan. Mandates send a signal to producers and the market and risk a huge increase in cost and a license to print money for fuel suppliers, while raising the price of mobility throughout the E.U., said Conrad Clifford, IATA Deputy Director General.

The Inflation Reduction Act in the United States shows the power of significant incentives in driving production, said Clifford. Without similar firepower being deployed in the E.U., the E.U. faces having to import SAF in order to meet its own targets, increasing costs and diminishing the environmental gains.

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'A Turning Point': The European Union Agrees To Decarbonize Air ... - Forbes

The European Union bloc is reportedly negotiating an amended deal withPfizer Inc(NYSE: PFE) andBioNTech SE(NASDAQ: BNTX) for around 70 million COVID-19 vaccine doses, despite the European public prosecutor opening a criminal investigation into their original agreement.

The updated proposal includes a new provision for member states to pay half price, about10,for each canceled dose.

The revised contract would allow the EU to upgrade to newer vaccines tailored to any future COVID-19 variants, the Financial Times reportedcitingpeople close to the matter.

Also Read:FDA Gives Green Signal To Second Omicron-Adapted Booster Shots For People At High Risk From Covid.

The report added that Poland and some other central European countries refuse to sign the amended deal because they do not want to pay for canceled doses.

But if the conditions can be persuaded, a revised deal would highlight the near-monopoly status enjoyed by BioNTech/Pfizer across the bloc.

If [BioNTech/Pfizer] supply around 70mn doses per year for the next few years, thats pretty much the totality of the market, said one person familiar with the negotiations.

A proposed deal for 70 million doses until 2026 threatens to push rivalsModerna Inc(NASDAQ: MRNA),Novavax Inc(NASDAQ: NVAX), andSanofi SA(NASDAQ: SNY) out of the market.

Sanofi and Novavax previously committed to orders with the EU that were much smaller than the numbers announced, people familiar with the matter said.

About 90% of doses delivered have since been unused, with a large proportion being destroyed or will be because either they passed their expiration dates or there was no demand for them.

Price Action:PFE shares are up 0.18% at $38.96 during the premarket session on the last check Monday. BNTX shares are down 2.21% at $111.72.

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This article European Union's Amended COVID-19 Vaccine Deal with Pfizer-BioNTech: Near-Monopoly Status Potential Threat to Rivals originally appeared on Benzinga.com

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European Union's Amended COVID-19 Vaccine Deal with Pfizer-BioNTech: Near-Monopoly Status Potential Threat to Rivals - Yahoo Finance

The European Union (EU) has just published its proposals to revise its general pharmaceutical legislation. One of the objectives of the revision is to reduce the regulatory burden on the pharmaceutical industry when seeking authorisations for new products and to provide a flexible framework to take account of the demands of innovation.

The EU is determined to remain a competitive regulatory jurisdiction compared to, for example, the United States. The proposals aim to streamline and simplify regulatory procedures and to future proof the legislation with a view to accommodating new technologies. The changes are expected to yield cost savings for the European pharmaceutical industry, in particular for small and medium sized enterprises.

After the electronic Common Technical Document (eCTD) submission was established for marketing authorisation applications over the last years, member states are now to be given the option to decide whether the package leaflet will be made available on paper or electronically or both. The European Commission (EC) has reserved a delegated power to make electronic package leaflets compulsory, but is only enabled to use this power starting 6 years and 6 months after the proposed new Directive to replace Directive 2001/83 (Draft Directive) enters into force.

The European Medicines Agency will be able to offer a phased, or rolling, review of data packages for individual modules of marketing authorisation applications. This will apply to medicinal products that are likely to offer an exceptional therapeutic advancement in the diagnosis, prevention or treatment of a life threatening or seriously debilitating or serious and chronic condition in the union.

The time scale for the grant of a marketing authorisation will be further accelerated, e.g. the scientific evaluation period before the opinion of the Committee for Medicinal Products for Human Use (CHMP) is reduced from 210 days to 180 days.

The role of the EMA in providing scientific advice is broadened. Undertakings and not for profit entities established in the EU may request scientific advice in parallel with the joint scientific consultation carried out by the Member State Coordination Group on Health Technology Assessment (HTACG). This will help developers of new medicines to ensure that their clinical trial programme generates the necessary evidence both for authorisation as well as for pricing and reimbursement decisions. Parallel scientific advice may also be sought from the expert panels established under the Medical Devices Regulation by applicants for marketing authorisation for medicinal products involving a medical device.

There will be enhanced scientific and regulatory support for priority medicines that, based on preliminary scientific evidence, are likely to address an unmet medical need or provide an exceptional therapeutic advancement.

The sunset clause, which led to medicinal products losing their marketing authorisation if not placed on the market within 3 years of grant, is abolished. Furthermore, marketing authorisations will generally be valid for an unlimited period without the need for renewal after five years.

A single assessment of an active substance master file will be introduced which will result in a certificate. The use of the certificate will be mandatory for subsequent applications concerning the same active substance. This procedure may in future be extended to excipients, adjuvants, radiopharmaceutical precursors and active substance intermediates.

The EMA will reduce the number of its standing committees to two, the Committee for Medicinal Products for Human Use (CHMP), and its safety committee, the Pharmacovigilance Risk Assessment Committee (PRAC). The Committee for Orphan Medicinal Products (COMP), the Committee for Advanced Therapy Medicinal Products (CAT), and the Paediatric Committee (PDCO) will become working parties, which can lend expertise to the CHMP as needed. The effect will be that applicants will only have to deal with one committee, rather than up to five in some cases at present, as they steer their products through the authorisation process.

The representation of patients and health care professionals will be increased at the CHMP and PRAC.

The EC hopes that this simplified structure will free up resources to focus on early scientific support to promising medicines and the repurposing of authorised medicinal products.

The place of adapted clinical trials in providing evidence to support the benefit/risk analysis in relation to new active substances is recognised in the draft legislation. A new concept of a regulatory sandbox is introduced. This is a controlled regulatory assessment framework set up for a limited time for developing or testing innovative or adapted solutions that facilitate the development and authorisation of products that might be regulated as medicinal products. A regulatory sandbox may be set up by the EC where it is not possible to develop a medicinal product in compliance with the existing regulatory requirements because of scientific or regulatory challenges related to characteristics of the product that positively contribute to the quality, safety or efficacy of the medicinal product or category of products or provide a major contribution to the access of patients to treatment.

Health data generated outside of clinical trials, including real world data, will play a role in regulatory decision making in future. The recitals to the proposed Regulation replacing Regulation 726/2004 suggest that the EMA will use data from the European Health Data Space (EHDS) as well as taking advantage of supercomputing, artificial intelligence and big data science.

The Draft Directive establishes three kinds of combination products: integral combinations of medicinal products with medical devices, medicinal products in exclusive use with medical devices and combinations of medicinal products with a product other than a medical device. Referring to integral combinations, Article 117 of the new Medical Devices Regulation (MDR) has already outlined, that the marketing authorisation dossier shall include, where available, the results of the assessment of the conformity of the device part with the relevant general safety and performance requirements according to the MDR. The Draft Directive provides more specific rules for the assessment of integral combinations of a medicinal product with a medical device, clarifying the interplay between the two regimes regulating medicines and medical devices. The benefit-risk balance of the integral combination will be assessed taking account of the suitability of the use of the medicinal product with the medical device.

The new proposals will need to be considered in detail by the Member States and debated and possibly amended by the European Parliament before the final versions of the new Medicines Directive and Regulation come into force. There will be an eighteen-month transitional period meaning that these new measures are not likely to become effective before 2026 or perhaps 2027.

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European Union to streamline medicines regulatory process to ... - JD Supra