30 June 2025
- The EU moves closer to a major reform of its regulatory framework for pharmaceuticals: Towards a more competitive EU pharma sector?
- The Government of Indonesia issues a new regulation to accelerate business licensing to ensure transparency, predictability, and investment
- No more ‘cauliflower steak’? Twelve EU Member States request the prohibition of the use of traditional meat names for plant-based products
- Recently adopted EU legislation
The EU moves closer to a major reform of its regulatory framework for pharmaceuticals: Towards a more competitive EU pharma sector?
By Stella Nalwoga, Tobias Dolle, and Paolo R. Vergano
On 4 June 2025, the Council of the EU (hereinafter, Council) adopted its negotiating position regarding the European Commission’s (hereinafter, Commission) proposals for a new Regulation laying down Union procedures for the authorisation and supervision of medicinal products for human use and establishing rules governing the European Medicines Agency and a new Directive on the Union code relating to medicinal products for human use (hereinafter, pharmaceutical package) to replace the EU’s existing general pharmaceutical legislation.
With the pharmaceutical package, the Commission undertakes the first major revision of the EU’s pharmaceutical legislation since 2004. This article provides an overview of the Commission’s proposals, analyses the amendments proposed by the European Parliament and the Council, and discusses how the reform would address the challenges being faced by the EU’s pharmaceutical sector.
The current regulatory framework
Currently, the EU’s regulatory framework for pharmaceutical products is based on Regulation (EC) No 726/2004 of 31 March 2004 laying down Community procedures for the authorisation and supervision of medicinal products for human and veterinary use and establishing a European Medicines Agency and Directive 2001/83/EC of 6 November 2001 on the Community code relating to medicinal products for human use. Separately, there is legislation on medicinal products for paediatric use, namely Regulation (EC) No 1901/2006 of 12 December 2006 on medicinal products for paediatric use and amending Regulation (EEC) No 1768/92, Directive 2001/20/EC, Directive 2001/83/EC and Regulation (EC) No 726/2004, and on ‘orphan’ medicinal products used to treat rare diseases, Regulation (EC) No 141/2000 of 16 December 1999 on orphan medicinal products. In view of recent developments and challenges, the Commission decided to review, update, and streamline this regulatory framework.
Addressing the challenges faced by the EU’s pharmaceutical sector
The Covid-19 pandemic exposed the inequalities across the EU in terms of patients’ access to medicinal products, lack of security of supply, medicine shortages, and dependency on non-EU countries for medicines and active ingredients (i.e., the substances that are pharmaceutically active in medicines), highlighting the need to ensure what the Commission describes as a “future-proof and crisis-resistant medicines regulatory system”.
Therefore, on 26 April 2023, the Commission had published the pharmaceutical package, with the following four objectives: 1) Ensuring timely, equitable access to safe, affordable, and effective medicines for all Europeans; 2) Enhancing the competitiveness of the sector by reducing the regulatory burden and simplifying the regulatory framework; 3) Addressing issues concerning security of supply of medicines through measures aimed at monitoring and preventing shortages; and 4) Mitigating the environmental impact of medicines via better enforcement of environmental rules.
The novelties being introduced through the pharmaceutical package include incentives for pharmaceutical companies to encourage innovation; shortened scientific evaluation and authorisation periods; simplified regulatory procedures; new requirements for companies to monitor, report, and prevent shortages; and stricter enforcement of environmental standards.
Regulatory data protection: innovation vs. access to medicines
Under the current legislation, a company producing innovative medicines benefits from eight years of regulatory data protection (hereinafter, RDP), during which competitors may not access the data used to develop those medicines, and a minimum of two years of market exclusivity during which generic, hybrid or biosimilar (i.e., pharmaceuticals that are highly similar to an already approved original medicine manufactured by a different company) versions of those medicines may not be sold by competitors. This means that innovators receive protection (RDP and market exclusivity) during a minimum of ten years.
The Commission proposes to shorten the RDP period to a baseline of six years, extendible under certain circumstances (e.g., unmet medical needs, clinical trials), while retaining two years of market exclusivity. Thus, under the new rules, innovators would receive total protection (RDP and market exclusivity) during a minimum of eight years. On 10 April 2024, the European Parliament had adopted its position on the Commission’s proposal. Members of Parliament agreed to reduce the RDP, but to a baseline of 7.5 years, extendible under certain circumstances, while retaining two years of market exclusivity, bringing the minimum total protection period to 9.5 years. The Council of the EU agreed to maintain the eight-year RDP period, but also proposed to reduce the market exclusivity period from two years to one year. As such, the minimum total protection would be nine years.
EU Member States with strong domestic pharmaceutical industries, such as Belgium, Germany, and France, had favoured longer RDP and market exclusivity periods in order to encourage innovation and investment. However, other EU Member States, notably Poland, argue that shorter periods are needed to increase access to medicines, prevent monopolies, and allow faster entry of generics, hybrids, and biosimilars onto the market.
Securing the supply of critical medicines
The Commission also seeks to streamline the EU’s regulatory procedures by reducing the standard review and approval timeline by over 50 days for centrally authorised medicinal products. To enhance the security of supply, the Commission foresees the creation of an EU-wide list of “critical medicinal products” for which insufficient supply would result in serious harm, or risk thereof, to patients. The European Medicines Agency (EMA) notes that products on this list would be “prioritised for EU-wide actions to strengthen their supply chains and minimise the risk of supply disruption”.
Additionally, EU Member States may require marketing authorisation holders to ensure that there are “appropriate and continued supplies” of their products within their respective territories, sufficient to meet national needs. Finally, to address concerns regarding sustainability, companies would be required to submit an “environmental risk assessment” when applying for market authorisation, which must cover the entire life cycle of the product and include risk mitigation measures. Authorities may refuse the granting of an authorisation if they consider that the identified risks are not sufficiently addressed.
Commercial implications
The pharmaceutical package has drawn mixed reactions from the pharmaceutical industry, indicating the different interests at stake. The European Federation of Pharmaceutical Industries and Associations (EFPIA) warned that shortening the RDP and market exclusivity periods would makeEurope “less attractive, discouraging investment and jeopardising the development of innovative treatments in Europe without addressing the underlying barriers and delays to patient access”. In contrast, Medicines for Europe, which represents manufacturers of generic and biosimilar medicines, supported the package and vowed to “oppose attempts to extend incentives and intellectual property rights which are already providing the longest monopoly protections in the world”.
Next steps
The Council of the EU, the European Parliament, and the Commission will now enter into inter-institutional ‘trilogue’ negotiations to reach a final agreement on the EU’s new regulatory framework for pharmaceuticals. Given the institutions’ divergent positions, the duration of the RDP and market exclusivity periods will certainly be a topic of debate. Stakeholders are advised to monitor proceedings closely, and to continue advocating for further changes.
For any additional information or legal advice on this matter, please contact Paolo R. Vergano
The Government of Indonesia issues a new regulation to accelerate business licensing to ensure transparency, predictability, and investment
By Joanna Christy, Caitlynn Nadya, and Paolo R. Vergano
On 5 June 2025, the Government of Indonesia issued Government Regulation No. 28 of 2025 on the Organisation of Risk-Based Business Licensing (hereinafter, GR No. 28/2025), repealing Government Regulation No. 5 of 2021. GR No. 28/2025 introduces updated criteria for the issuance of business licenses across 22 business sectors in Indonesia. The issuance of GR No. 28/2025 further simplifies the licensing requirements for business actors, particularly small and medium enterprises, while placing greater emphasis on digitalisation, as well as on Environmental Licenses (Persetujuan Lingkungan).
This article discusses Indonesia’s risk-based licensing approach, the key changes introduced by GR No. 28/2025, and the implications for relevant stakeholders.
Indonesia’s risk-based licensing
GR No. 5/2021 had introduced a number of criteria regarding the issuance of licensing requirements for 16 business sectors, which are based on the assessment of the risk level of the respective business activity. The term ‘risk’ is defined as the “potential for injury, or loss from a hazard, or a combination of possibilities and consequences of danger”, which are determined based on considerations relating to health, safety, environmental impact, and utilisation of resources.
Based on the risk analysis, business activities are classified into one of the following risk-level types: 1) Low-risk (e.g., department stores); 2) Medium-low risk (e.g., furniture manufacturing by small and medium-sized enterprises); 3) Medium-high risk (e.g., import and distribution of cosmetics); and 4) High-risk (e.g., waste management service and chemical manufacturing). The risk level determines the business licensing requirements and, in simple terms, the lower the ‘business risk’, the simpler the business licensing requirements (see Trade Perspectives, Issue No. 14 of 16 July 2021).
The novelties under GR No. 28/2025
GR No. 28/2025 is now the key regulation governing Indonesia’s risk-based business licensing framework. While the regulation maintains the core obligations and principles related to assessing business activities based on the respective risk level, GR No. 28/2025 introduces a number of key changes. Notably, GR No. 28/2025 expands the scope of coverage from 16 to 22 business sectors and now also covers certain business activities in the creative economy (e.g., interior design, handicraft) and businesses operating in electronic systems and electronic transactions (e.g., e-commerce and online payment platforms).
In addition to the broader scope, GR No. 28/2025 introduces several other enhancements, notably the mandatory use of the Online Single Submission (hereinafter, OSS) platform, the addition of a new chapter on Business Licensing to Support Business Activities (i.e., Perizinan Berusaha Untuk Menunjang Kegiatan Usaha, PB UMKU), enhanced provisions on environmental licensing, and detailed rules on eight types of tax facilities that businesses may apply for.
Addressing further licenses required for certain business activities
Business Licensing to Support Business Activities refers to a secondary layer of licensing required for the operational and/or commercial stage of a business, to be obtained after the business license has been issued and complementing the business licences. According to Article 135 of GR No. 28/2025, Business Licensing to Support Business Activities includes permits for product distribution, operational feasibility, and product or service standardisation, which are particularly relevant in sectors involving regulated products or services. Chapter IV of GR No. 28/2025 sets out detailed requirements for such licenses. Ministries and government agencies are responsible for identifying which licences apply, taking into account the risk level of the business activity or of the product at the operational stage.
Notably, the Business Licensing to Support Business Activities does not concern trade-related permits, such as licences related to export, import, or commodity balance, which remain regulated separately and can be requested through the Indonesia National Single Window. By clearly regulating Business Licensing to Support Business Activities as a distinct step that follows the issuance of a business license, GR No. 28/2025 helps distinguish between the initial approval to start a business and the additional permits needed to begin operating or offering products to the market. While framed as a measure to improve legal certainty, GR No. 28/2025 appears more focused on reinforcing oversight in sectors with heightened public health, safety, or environmental risks, such as in the areas of food and beverages, cosmetics, pharmaceuticals, energy, and medical devices. As a result, rather than simplifying procedures, it arguably increases the complexity of the licensing process.
Streamlining environmental approvals
GR No. 28/2025 introduces key changes to the process for Environmental Licenses, with a shift towards full digitalisation and stricter timelines. Under Article 78 of GR No. 28/2025, Environmental Licenses are granted based on the submission of one of three environmental documents: 1) An Environmental Impact Analysis; or 2) The Form on Environmental Management and Monitoring Efforts; or 3) A Statement of Environmental Capability, depending on the nature and risk of the business activity.
GR No. 28/2025 mandates that the entire process, from application to issuance of the licenses, be conducted electronically via the OSS system. Moreover, Article 83 of GR No. 28/2025 sets deadlines for technical assessments determining whether a business activity meets specific environmental standards, such as limits on emissions, wastewater discharge, and hazardous waste management. These assessments must now be completed within specific timeframes (e.g., assessments related to wastewater discharge and air emissions must be completed within 30 working days). Importantly, the environmental licenses and relevant technical approvals, which were previously handled sequentially, can now be processed in parallel, helping to reduce delays without compromising environmental oversight.
For integrated business activities involving multiple Indonesian Standard Industrial Classification (hereinafter, ISIC) codes (i.e., the standard classification system used in Indonesia to categorise business activities), Article 78(6) of GR No. 28/2025 allows the use of a single, consolidated environmental document, provided that the activities are conducted within the same ‘ecosystem’. For example, a palm oil company that owns both the plantation and the crude palm oil mill located on the same plot can pursue a unified environmental document. In such cases, the environmental assessment must follow the highest applicable standard among the relevant ISIC codes, meaning that the most stringent environmental documentation requirement must be applied.
Implications for businesses
The digitalisation of environmental licensing under GR No. 28/2025 aims at ensuring that business actors, whose activities fall within the risk classification system, particularly those in environmentally sensitive sectors, such as energy, fertilisers, and waste management, can now be monitored through a transparent and traceable compliance record within the OSS system. The ability to digitally track and verify a company’s environmental compliance history has growing significance in international trade, where foreign buyers and regulators increasingly demand verifiable environmental documentation as part of rules on Environmental, Social, Governance (hereinafter, ESG) due diligence, as well as under certain regulatory requirements, such as under the EU’s Corporate Sustainability Due Diligence Directive.
A digital and centralised licensing record can support Indonesia’s exporters in complying with these requirements and can reduce the risk of border check delays. However, GR No. 28/2025 also introduces new regulatory requirements that could increase compliance costs for businesses. For instance, additional permits, such as those for ‘operational feasibility’, may be seen as unnecessary or redundant, particularly in sectors that are already highly regulated. These added steps not only prolong the licensing process, but will also likely add additional administrative and financial burdens for businesses.
For any additional information or legal advice on this matter, please contact Paolo R. Vergano
No more ‘cauliflower steak’? Twelve EU Member States request the prohibition of the use of traditional meat names for plant-based products
By Amanda Carlota, Ignacio Carreño García, and Tobias Dolle
During meeting of the EU’s Agriculture and Fisheries Council on 23 and 24 June 2025, the delegation from Czechia presented an initiative on the Protection of traditional names for food of animal origin, signed by twelve EU Member States. The initiative, which is led by Czechia, Austria, Hungary, Italy and Slovakia, and supported by France, Ireland, Luxembourg, Malta, Portugal, Romania and Spain, calls on the European Commission (hereinafter, Commission) to introduce greater protection of traditional names for food of animal origin so that these names may not be used for plant-based foods.
This article discusses the initiative, and other related proposals, and provides an overview of the EU’s current legislation and jurisprudence on the naming and labelling of plant-based foods.
The controversy over ‘meaty’ and dairy names for plant-based products
At the EU level, for a number of years now, there has been a heated debate on the use of ‘meaty’ and dairy names for plant-based products. For plant-based dairy names, such as ‘milk’ or ‘yoghurt’, the debate was mostly settled on 14 June 2017, when the Court of Justice of the European Union (hereinafter, CJEU) issued its judgment in the TofuTown case (see Trade Perspectives, Issue No. 14 of 18 July 2022). For meat products, with a few exceptions, there are no legal names, similar to those for dairy products.
Annex VII to Regulation (EU) No 1308/2013 of the European Parliament and of the Council establishing a common organisation of the markets in agricultural products (hereinafter, CMO Regulation) contains only general sales descriptions for meat of bovine animals (like ‘veal’ in English), but currently no different language versions of meat products like ‘sausage’, ‘prosciutto’, or ‘Schnitzel’. In 2020, in the context of the Commission’s Proposal revising the CMO Regulation, Members of the European Parliament had proposed to reserve the use of meat-related terms and names such as ‘steak’, ‘sausage’, or ‘burger’, “exclusively for products containing meat”. Such proposed amendment was finally not adopted.
There is also recent jurisprudence of the CJEU on the matter. On 4 October 2024, the CJEU issued a preliminary ruling concerning France’s Decree No. 2022-947 of 29 June 2022 on the use of certain names used to designate foodstuffs containing vegetable proteins. The CJEU ruled that EU Member States may not prohibit the use of commonly used terms if they are not defined by law. As a result, EU Member States are not permitted to restrict manufacturers of plant-based meat substitutes from using ‘meaty’ terms, such as ‘steak’.
The new initiative on the protection of traditional names of food of animal origin
The new initiative, led by Czechia, notes that “the food market in the EU is increasingly composed of products that consist only of plant-based ingredients and are similar in appearance, taste and consistency to products of animal origin” and that “these plant-based foods are very often labelled with the names belonging to meat, eggs, honey, fish and products made from them”. The initiative claims that “plant-based products differ substantially from food products of animal origin, particularly in terms of composition and nutritional value”. The initiative concludes that “it is essential that foods which imitate, mimic or substitute foods of animal origin do not mislead the consumer by their labelling as to their true nature” and suggests that a “harmonisation of legal protection could be provided within the framework of the planned revision” ofthe CMO Regulation. In this regard, the signatory EU Member States call on the Commission to “submit a legislative proposal to protect the names of food of animal origin, providing them with the similar long-standing protection as milk and dairy products”.
There is already a separate initiative in the European Parliament in the context of the Commission’s Proposal for a Regulation amending Regulations (EU) No 1308/2013, (EU) 2021/2115 and (EU) 2021/2116 as regards the strengthening of the position of farmers in the food supply chain. Amendment 645 proposes to add a new Part IIa on ‘Meat, meat products and meat preparations’ to Annex VIII to the CMO Regulation. With respect to ‘meat’, it states, in relevant part, that “The meat-related terms and names that fall under Article 17 of Regulation (EU) No 1169/2011 and are currently used for meat and meat cuts shall be reserved exclusively for the edible parts of the animals”. With respect to ‘meat products’, Amendment 645 states that “Names that fall under Article 17 of Regulation (EU) No 1169/2011 that are currently used for meat products and meat preparations shall be reserved exclusively for products containing meat. These names include, for example: Steak, Escalope, Sausage, Burger, Hamburger, Egg yolk, Egg white”. Finally, the proposed amendment provides that “The above-mentioned names shall not be used for any product other than the products referred to and shall exclude cell-cultured products”.
Legal names for meat and meat products may be set
In its preliminary ruling of 4 October 2024, the CJEU summarises the relevant provision of Article 17 of the EU’s Regulation (EU) No 1169/2011 on the provision of food information to consumers (hereinafter, Food Information Regulation, FIR) on the naming of food as follows: 1) Foods must bear a name; 2) That name must be a legal name or, in the absence of such a name, a customary name or, failing that, a descriptive name; 3) That name must be accurate, clear and easy to understand for the consumer; 4) That name must not mislead consumers, particularly as to the characteristics of the food concerned, which include its nature and composition, and as to the substitution of components naturally present or ingredients normally used with different components or different ingredients; and 5) Such requirements must be complied with when marketing and promoting any food.
The CJEU acknowledged that the FIR permits EU Member States to adopt legal names where such names are not regulated at the EU level. Where legal names are set, these may not be used for products not complying with the specifications related to those names. As an example, the CJEU refers to the term ‘meat’, which is legally defined as ‘the edible parts of animals’. A food not containing such parts of animal origin may, therefore, not use the name ‘meat’, even if it is accompanied by terms such as ‘vegetarian’. Importantly, the CJEU considered that France’s Decree No. 2022-947 did not provide any ‘legal name’, but rather concerned the question of which ‘customary names’ or ‘descriptive names’ may not be used to designate vegetable protein-based foods. The CJEU ruled that legal names must, on the basis of the FIR, be defined in order to designate a foodstuff, associating a specific expression with a given food by establishing certain conditions, namely with regard to the composition of the food.
It appears that the definitions for meat, meat products, and meat preparations proposed by Amendment 645 for inclusion in the CMO Regulation do not meet the requirement for legal names, namely “associating a specific expression with a given food by establishing certain conditions, namely with regard to the composition of the food”. The proposed amendment provides that “Meat-related terms and names that are currently used for meat and meat cuts shall be reserved exclusively for the edible parts of the animals” and provides for some examples. Notably, the amendment does not provide any “association of a specific expression with a given food by establishing certain conditions, namely with regard to the composition of the food”.
Conclusions
Prohibiting ‘meaty’ names for plant-based products would have important commercial implications for companies that have been using them for a number of years now. The definition of such terms may not be warranted and legally necessary in the consumers’ interest. Notably, the existing provisions of the FIR may provide a sufficient legal basis to protect consumers from being misled by denominations for plant-based meat alternatives, if those are also clearly denominated as ‘vegan’ or ‘vegetarian’.
The Commission’s Proposal for the broader reform of the CMO Regulation will be part of the proposal for the EU’s post-2027 Common Agricultural Policy, which is expected for mid-July 2025. Interested businesses should monitor the developments in the EU and its Member States on the use of ‘meaty’ names for plant-based products and stakeholders should be prepared to participate in the debate by interacting with relevant EU Institutions, trade associations, and other affected stakeholders.
For any additional information or legal advice on this matter, please contact Ignacio Carreño Garcia
Recently adopted EU legislation
Customs Law
Market Access
Trade Remedies
Food Law
Amanda Carlota, Ignacio Carreño García, Tobias Dolle, Joanna Christry, Caitlynn Nadya, Stella Nalwoga, and Paolo R. Vergano contributed to this issue.
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