Pact for Skills Archives - European Industrial Pharmacists Group (EIPG)

The risk of a biosimilar void in Europe

by Giuliana Miglierini The undergoing revision of the pharmaceutical legislation aims, among others, to redefine data protection to better support competitiveness of generics and biosimilars and to favour the timely access of patients to treatments. While the innovator pharma industry is Read more

The drug shortage situation - EIPG's point of view

by Maurizio Battistini The shortage of medicines has been a major concern in the countries of the European Union, and elsewhere, for more than 10 years, so much so that the Economic Community has devoted a great deal of effort Read more

EP’s draft position on Unitary SPC and SPC Regulation revision

by Giuliana Miglierini The Committee for Legal Affairs (JURI) of the European Parliament released the draft amendments to the Commission’s proposals aimed to establish a Unitary Supplementary Protection Certificate (SPC) (links to the document and to the procedure) and to Read more

EC Communication (part 2): a Critical Medicines Alliance to support European pharma supply chain

, , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , ,

by Giuliana Miglierini

After last week’s examination of the first part of the Commission’s Communication, specifically targeted to short-term actions to prevent and mitigate critical medicine shortages, in this second post we will address the announced mid- and long-term structural measures, focused on the creation of the Critical Medicines Alliance, the diversification of supply chains and the role of international partnerships.

The Critical Medicines Alliance

The second part of the Commission’s Communication details the structural measures to strengthen the secure supply of pharmaceuticals in the EU, with particular reference to critical medicines. An objective that, according to the Commission, may require the development of new pieces of legislation, such as the EU Critical Medicines Act. To this instance, the preparatory study should be launched by the end of 2023, and followed by the impact assessment.

In the meantime, the improved coordination of the industrial approach to the management of shortages in the EU should be pursued by the Critical Medicines Alliance, to be created in early 2024. The Alliance will bring together all involved stakeholders; its activities should start from a shared analysis of vulnerabilities in the supply chain of the critical medicines on the Union list (i.e over-dependency on a limited number of external suppliers, limited diversification possibilities, limited production capacities, etc).

The result of this exercise should be the identification of useful tools to address vulnerabilities of a limited number of critical medicines with the highest risk of shortages and impact on healthcare systems. To this regard, several lines of actions are identified in the Communication, starting from the issuing of a dedicated guidance and common criteria for the coordinated procurement of critical medicines (e.g. green production and prioritisation of supplies in Euro-pe at times of critical shortages). A better quantification of demand and the consequent possibility to compensate and incentivise industry for its effort in these directions are other expected outcomes.

Medium-term contractual incentives are proposed as a tool to improve predictability of supply and to attract new manufacturing investments in Europe, together with the use of capacity reservation contracts modelled on EU FABs. These last instruments were launched by the HERA Authority during the pandemic in order to reserve manufacturing capacities for vaccines and obtain a priority right for their manufacturing in case of a future public health emergency.

The second line of action of the Alliance would address the diversification of global supply chains for critical medicines, including the identification of priority countries to be involved in strategic partnerships on the security of supply (see also below).

The third pillar should see the Alliance involved in the coordination and harmonisation of efforts to identify security of supply needs for critical medicines, on the basis of the above-mentioned identified vulnerabilities. Actions cited by the Communication, such as the Services of General Economic Interest (SGEI) coordinated at the EU level, should be compatible with the state aid framework. The Alliance may also represent the dedicated location where member states may better discuss the possibility of a new Important Project of Common European Interest (IPCEI) focusing on sustainable manufacturing of critical medicines (including off patent medicines).

Stockpiling, skills and financial support

EU stockpiling of critical medicines is another area of activity of the Critical Medicines Alliance. The goal is to overcome current limitations typical of national stockpile programmes; the development of a common strategic approach and a Joint Action on stockpiling has been announced for the first half of 2024, based on the previously mentioned vulnerability analysis and on the experience of the Union Civil Protection Mechanism (UCPM, that will continue to be part of the EU approach) and the rescEU stockpile.

The Alliance should also address the need for new and updated skills to work in the pharmaceutical sector, so to cope with the increasing impact of digitalisation, the evolution of the regulatory environment and the green transition. Pharmacists are cited in the Communication, as their curricula could be easily adjusted to accommodate education and training on new skills. Attention should be paid to increasing STEM (Science, Technology, Engineering and Mathematics) graduates. A Pact for Skills is the measure identified to actively involve key actors in educational and training activities aimed to fill industry skills gaps.

The Alliance would also play a significant role in better leverage and align EU and national funding: a goal deemed important in order to support improved long-term investment predictability for the private sector, and to avoid duplication of efforts. Among other tools cited by the Communication to reach it, the proposed Strategic Technologies for Europe Platform (STEP) is also inclusive of pharmaceuticals, biotechnologies and medical technologies. The creation of a Sovereignty Seal to promote synergies amongst existing programmes, and the Technical Support Instrument to enhance the administrative capacity of member states in managing shortages and producing critical medicines are among other proposed tools.

Diversification of supply chains

A second, fundamental line of action identified by the Commission addresses how to better diversify the complex, global pharmaceutical supply chain, also by means of new international partnerships with third countries. According to the Communication, the EU industry needs to have access to a broad range of essential inputs; to this regard, new strategic partnerships with third countries for production of critical medicines and active ingredients should be based on concrete actions of mutual interest.

The EU has 42 preferential trade agreements in place with 74 different trading partners, and a new one is under negotiation with India. The Commission also recalled the importance of bilateral meetings with China on issues affecting access to medicines supply chains, and of the dialogue with Latin America.

An improved regulatory convergence is another main objective of the planned actions at the international level, so to increase GMP compliance of medicinal products marketed in the EU and manufactured by extra-UE partners. To this instance, the Communication mentions the work of international bodies such as the ICH (International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use) and ICMRA (International Coalition of Medicines Regulatory Authorities) for the harmonisation of standards for pharmaceuticals, and the WHO support to improved regulatory convergence. Many free trade and mutual recognition agreements (MRAs) signed by the EU also contain this type of obligation, and in some cases the sharing of non-sensitive market knowledge to anticipate possible problems too.

A new network of international partners should be created by the Commission within a year, in conformity with applicable state aid and antitrust rules. The network activities would focus on crisis preparedness and supply diversification. The Communication mentions also different international initiatives already in place, such as the Global Gateway to support local manufacturing of health products and announced another Team European Initiative in Africa on health security and pandemic preparedness and response. Another ongoing initiative is the EU-Latin America and Caribbean Partnership on manufacturing and access to vaccines, medicines and health technologies. The EU will also continue to support the provision of critical medicines in humanitarian contexts.

EU’s Industrial Forum, the future of advanced manufacturing technologies

, , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , ,

by Giuliana Miglierini

The expert group “Industrial Forum” is a multistakeholder body created by the European Commission to support the implementation of the Industrial Strategy launched in March 2020 and its following update of May 2021. Its members include Member States authorities, NGOs, industrial representations, research institutions and social partners representing different industrial ecosystems.

Its recently published report is the result of the structured dialogue among members on how to accelerate the deployment of advanced manufacturing technologies (AMTs) across the European industry. Among members which participated in the drafting of the document is also EuropaBio on behalf of the biomanufacturing industry.

Europe is leader in advanced manufacturing

Advanced manufacturing is based on the integration and convergence of the most advanced industrial technologies, i.e. automation, robotics, artificial intelligence and digitally connected solutions. New processes, new products as well as new business models based on this new approach are deemed to represent a fundamental competitive factor in the next few years.

Europe is currently well position in the ranking on “future of production” readiness, with 18 out of 25 countries considered by the World Economic Forum to be leading the change in manufacturing. Despite this, according to the report many efforts are still needed to accelerate the implementation of advanced manufacturing technologies in the EU, so not to be superseded by other fast-evolving competitors.

In order to achieve this challenging goal, the Industrial Forum identified seven different areas of attention, each of which is addressed by specific recommendations based on a SWOT analysis.

The seven areas of recommendation

The transition to new manufacturing models should, first of all, meet the EU sustainability goals established by the European Green Deal: the “net-zero industry” plan for renewables and industrial efficiency technologies is confirmed as a priority action, together with the expansion of the use of REPowerEU. The Commission is working on new energy savings directives, which should be timely implemented. Circularity of manufacturing processes and products is another main goal of EU’s industrial policies, to be supported by a set of new fit-for-purpose rules. A more rapid uptake of advanced manufacturing technologies should also be supported by both the availability of specific public procurement guidance and a targeted communication of the environmental benefits of European clean technologies.

The second area of action addresses how to improve access to capital, a key factor in ensuring the timely implementation of advanced manufacturing technologies. This may include a better use of public investment, as well as a cautious application of state aid instruments specifically targeted at later stages in the innovation and deployment process. The potential of these new technologies for sustainability should also be recognised within the upcoming EU Taxonomy de-legated acts.

The resilience of supply chains could be tackled by the rapid implementation of AMTs. In order to achieve this goal, the Industrial Forum highlighted the need for workable and proportionate rules on Due Diligence. No less important is the negotiation and activation of new Free Trade Agreements with third countries (such as the EU-Mercosur FTA). A critical area refers to the improvement of EU semiconductor capacity. According to the report, incentives and funding aimed to increase the supply chain resilience should be exempt from directing specific outcomes. The European institutions should also better support the local and regional industrial supply chains. Secure access to critical raw materials should be pursued by leveraging the trade policy.

The building of an EU Single Market is a main goal of the European Commission, also in the pharmaceutical field. Its freedoms should be safeguarded by narrowing down the scope of the Single Market Emergency Instrument, while promoting mitigation measures for advanced manufacturing. The Industrial Forum also recommends the availability of a single platform to provide companies with all the needed information to expand and/or export. Furthermore, a Single Market test should be included in the impact assessments of national laws to minimise the occurrence of gold-plating phenomena. New standards for AMTs would also be needed, an area which according to the Industrial Forum should conjugate an enhanced flexibility in standardisation requests and timely delivery in standard setting. Digital product standardisation should also be promoted, and adhesion to the New Legislative Framework should be ensured.

Data is a fundamental asset of the new economy. Recommendations in this area include supporting existing initiatives to create a strong European manufacturing data space, as well as ad-dressing the protection of both personal data and intellectual property rights and trade secrets. As artificial intelligence (AI) will assume an increasingly relevant role in future advanced manufacturing processes, the Forum recommends the development of clear, focused criteria on high-risk AI, while avoiding unnecessary regulation of industrial AI.

The availability of data should be pursued through the identification of a method for data collection in the advanced manufacturing category. It would also be important to generate trusted data sets at the European level for advanced manufacturing deployment, global competitive position, and economic / environmental / societal gains.

Many new skills will be needed in the next few years to handle the expansion of AMTs. To this instance, the Industrial Forum highlighted the importance to promote the harmonisation of Vocational Education and Training (VET) practices and qualification systems and to encourage women and girls to study STEM subjects and working in manufacturing. Other recommendations re-fer to the possibility of developing a Pact for Skills partnership and the proposal of a Blueprint Alliance for Advanced Manufacturing. A better entrepreneurial culture in Europe should also be promoted, as well as capitalisation on European creative industries.

Examples of biomanufacturing

Weaknesses to biomanufacturing identified by the Industrial Forum include the fact that it is still an emerging production process compared to chemical manufacturing. The report also mentions existing regulatory barriers, mainly linked to a process rather than product approvals pathway. Furthermore, significant investments in biomanufacturing are primarily located outside Europe. Possible risks identified by the report also refer to biomanufacturing being excluded or overlooked in key policymaking e.g. taxonomy supporting biomanufacture and sustainable financing.

The report includes two examples of AMTs linked to the health and agrifood sector. Chimeric antigen receptor T cells (CAR-T) represent one of the main areas of innovation in cancer treatment over the past two decades, in which the patient’s immune cells are engineered to produce the final immunotherapy. Many pharmaceutical companies are building specialised manufacturing facilities for CAR-T therapies within Europe, a biomanufacturing process which is highly complex and patient-specific, and requires long term investments, skills development, and integration into the European Union industrial base.

Biomanufacturing may also be applied to the production of vitamin B2 (riboflavin), that multi-step chemical synthesis is complex, requires hazardous agents and has low yields (~60%). Biotechnologies allow for the one-step production of vitamin B2, starting from vegetables as carbon sources and using a genetically modified bacterium (Bacillus subtilis) or fungus (Ashbya gossypii).