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Have Your Say! Revision of the EU General Pharmaceuticals Legislation

Have Your Say! Revision of the EU General Pharmaceuticals Legislation

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On 21 September 2021, the Commission launched a public consultation on the revision of the general pharmaceutical legislation. The public consultation ends on 21 December 2021. Any interested party may submit comments and observations. The consultation concerns certain key topics such as access and affordability, solutions to address unmet medical needs, incentives for innovation, medicine shortages, environmental challenges and sustainability. The amendments of the general pharmaceuticals legislation may be however much wider in scope, in line with the strategic areas identified in the Pharmaceutical Strategy for Europe, as part of which the public consultation is organized. Following the consultation process, the Commission will adopt a final legislative proposal, which is expected to be published by the fourth quarter of 2022.

Introduction

On 25 November 2020, the Commission published a Communication on a Pharmaceutical Strategy for Europe. The strategy identifies certain key pillars for which legislative and non-legislation action is required in order to address existing dysfunctionalities and keep up with market and technological developments.  

As part of the implementation of the Pharmaceutical Strategy for Europe, the Commission is evaluating the general pharmaceutical legislation and assessing the impact of possible changes in the legislation.

In this context, a public consultation was organized in order to collect views of stakeholders and the general public to support the evaluation of the existing general pharmaceutical legislation and the impact assessment of its revision.

Comments and observations can be submitted as part of the public consultation through the ‘Have your say’ portal.

In parallel, the legislation for medicines for rare diseases and children is being revised as well. Separate consultation activities have been carried out for that revision. The revision of the legislation for medicines for rare diseases and children is not covered by this article.

Topics covered by the public consultation

The consultation process covers the following main topics:

  • Unmet medical needs and market failures for medicines other than medicines for rare diseases and children;
  • Unequal access to available and affordable medicines for patients across the EU;
  • The current legislative framework may not be fully equipped to respond quickly to innovation;
  • Inefficiency and administrative burden of regulatory procedures;
  • Vulnerability of supply of medicines, shortages of medicines;
  • Environmental challenges and sustainability.

Participants to the public consultation process may propose any other topics to be considered for the legislative amendments.

The topics covered by the public consultation are summarized below.

Unmet medical needs

The initiative aims to identify elements that are important in defining what is unmet medical need and in which areas of unmet medical need innovation should be stimulated.

The following criteria area considered: (i) seriousness of a disease; (ii) absence of satisfactory treatment authorised in the EU; (iii) therapeutic advantage over existing treatment(s); (iv) lack of access for patients across the EU to an authorised treatment.

Incentives for innovation

The general pharmaceutical legislation provides regulatory data and market protection for new products. This data protection makes sure that another pharmaceutical company cannot re-use the proprietary data of the innovator for 8 years. Market protection makes sure that a generic or biosimilar medicine cannot be marketed until 10 years after authorisation. This dual protection shields a pharmaceutical innovator from generics or biosimilars on the market for 10 years. This protection is part of the EU system of incentives for innovation.

The revision initiative covers additional incentives, such as:

(i) providing longer protection in areas of unmet medical need;

(ii) reducing the data and market protection periods to allow earlier access for generic and biosimilar medicines to the market;

(iii) providing other type of incentives for medicines addressing an unmet medical need

Examples of new incentives are a transferable exclusivity voucher or a priority review voucher. A transferable exclusivity voucher would give the legal right to extend the protection time period of any other patented medicinal product, in exchange for the successful regulatory approval of a specified medicine for unmet medical need (e.g. an antibiotic). The voucher would be transferable or saleable, and may impact the turnover and profitability levels of other products in a developer’s portfolio. A priority review voucher gives priority to the assessment of the application of the medicine in question or another medicine in the applicant’s portfolio.

(iv) early scientific support and faster review/authorisation of a new promising medicine for an unmet medical need

(v) require transparent reporting from companies about their research and development costs and public funding as a condition to obtain certain incentives.

Antimicrobial resistance

Incentives for the development of new antimicrobials as well as possible option on their prudent use may be introduced in the amendments to the pharmaceuticals legislation.

More adapted, agile and predictable regulatory framework for novel products

Novel products and innovative solutions continue to challenge the understanding of a “medicinal product” with low volume, and cutting-edge products (e.g. medicines combined with self-learning artificial intelligence) becoming a new reality. ‘Bedside’ manufacture of more individualised medicines changes the way medicines are produced. There are classification and interplay challenges with other medical products, such as medical devices and substances of human origin, or related to the combination of clinical trials with in vitro diagnostics/medical devices and medicines. In addition, certain cell-based advanced therapy medicines are offered in hospital settings and are exempted from aspects of the pharmaceutical legislation. These developments offer possibilities for novel promising treatments and new ways of authorising and monitoring medicines but they are also testing the limits of the current regulatory system. They need to be addressed to unfold their potential while safeguarding the principles of high quality, safety and efficacy of medicines.
Digital transformation is affecting the discovery, development, manufacture, evidence generation, assessment, supply and use of medicines. Medicines, medical technologies and digital health are becoming increasingly integral to overarching therapeutic options. These include systems based on artificial intelligence for prevention, diagnosis, better treatment, therapeutic monitoring and data for personalised medicines and other healthcare applications.

The following measures are considered to encourage the development and marketing of novel products:

(i) make use of the possibility for ‘regulatory sandboxes’ in legislation to pilot certain categories of novel products

Some very innovative solutions fail to see the light of day because of regulations which might be outdated or poorly adapted for fast evolving technologies. One way to address this is through regulatory sandboxes. This enables innovative solutions not already foreseen in regulations or guidelines to be live-tested with supervisors and regulators, provided that the appropriate conditions are in place, for example to ensure equal treatment. Regulatory sandboxes provide up-to-date information to regulators and supervisors on, and experience with, new technology, while enabling policy experimentation.

(ii) creating more flexibility for medicines that are manufactured from substances of human origins, as well as for substances that are donated by humans such as blood, plasma, cells, gametes, tissues and organs that are applied as therapy.

(iii) more coordination among clinical trial, marketing authorisation, health technology assessment bodies, pricing and reimbursement authorities and payers for integrated medicines development and post-authorisation monitoring.

Improved access to medicines

The initiative aims to address differences in access to medication between EU countries. This will be done through rewards/ incentives and establishing new obligations such as:

(i) introduce incentives for swift market launch across the EU

(ii) allow early introduction of generics in case of delayed market launch of medicines across the EU

(iii) require companies to place – within a certain period after authorisation – a medicine on the market of the majority of Member States, that includes small markets

(iv) require companies withdrawing a medicine from the market to offer another company to take over the medicine.

Improved medicine affordability

Proposed measures are considered to address/ eliminate existing barriers for medicines entering the EU market. The measures concern mainly generics and biosimilars, which are seen as a means of ensuring accessible and affordable treatments, and increasing competition on the market:

(i) stimulate earlier market entry through a broader possibility to authorise generics/biosimilars despite ongoing patent protection

(ii) create a specific (regulatory) incentive for a limited number of biosimilars that come to the market first

(iii) introduce an EU-wide scientific recommendation on interchangeability for specific biosimilars

(iv) introduce joint procurement practices

Repurposing of medicines

Measures are considered with the objective to identify the opportunities and address any regulatory burdens to facilitate repurposing of off-patent, affordable medicines (i.e. provide additional uses of medicine against new diseases and medical conditions).

Security of supply

Shortages of medicines and the vulnerabilities in the pharmaceutical supply chain continue to be concerns in the EU. Shortages of medicines can have serious impacts on patient care. Under the current pharmaceutical legislation, pharmaceutical companies and wholesalers must, within the limits of their responsibilities, ensure a continued supply of medicines once they are placed on the market in the EU.

Still, there are significant dysfunctionalities and the exiting legislation and enforcement actions of the authorities fail to ensure that patients have adequate access to medication.

The following measures are considered:

(i) earlier reporting of shortages and market withdrawals

(ii) companies to have shortages prevention plans

(iii) companies to have safety stocks (obligation which was already implemented in Romania)

(iv) monitoring of supply and demand at national level

(v) require companies to diversify their supply chains

Quality and manufacturing

Several measures are envisage, including to implement the selected environmental requirements for manufacturing of medicines in line with the one health approach on antimicrobial resistance (The one-health approach is a holistic and multi-sectorial approach to addressing antimicrobial resistance).

Environmental challenges

The initiatives aims to address the fact that the environmental risk assessments (ERAs) is currently not taken into account in the overall benefit/risk analysis which influences the delivery of a marketing authorisation (MA) of a medicine. The considered measures include:

(i) strengthen the environmental risk assessment during authorisation of a medicine, including risk mitigation measures, where appropriate

(ii) harmonize environmental risk assessment by national regulators

Final remarks

The amendment of the general pharmaceuticals legislation is a complex process which may have significant practical impact on key areas for the pharmaceutical sector. The public consultation initiated by the Commission is a great opportunity for interested parties to submit feedback and express their position regarding the changes that are considered by the Commission.    

By Vadim Barbu, Counsel, DLA Piper

Romanian Knowledge Partner

Țuca Zbârcea & Asociații is a full-service independent law firm, employing cross-disciplinary teams of lawyers, insolvency practitioners, tax consultants, IP counsellors, economists and staff members. It also operates a secondary law office in Cluj-Napoca (Romania), and has a ‘best-friend’ agreement with a leading law firm in the Republic of Moldova. In addition, thanks to the firm’s dedicated Foreign Desks, the team provides the full range of services to international investors seeking to gain a foothold or expand their existing operations in Romania. Since 2019, the firm and its tax arm are collaborating with Andersen Global in Romania.

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