Source: EURLEX
Language: en
Format: md

**Council of the**
**European Union**

**Interinstitutional File:**

**2023/0129(COD)**

**COVER NOTE**

**Brussels, 2 May 2023**
**(OR. en)**

**8901/23**
**ADD 5**

**PI 58**
**PHARM 69**
**COMPET 387**
**MI 355**
**IND 209**
**IA 91**
**CODEC 751**

From: Secretary-General of the European Commission, signed by Ms Martine
DEPREZ, Director

date of receipt: 27 April 2023

To: Ms Thérèse BLANCHET, Secretary-General of the Council of the
European Union

No. Cion doc.: SWD(2023) 122 final

Subject: COMMISSION STAFF WORKING DOCUMENT EXECUTIVE
SUMMARY OF THE IMPACT ASSESSMENT REPORT Accompanying
the document Proposal for a Regulation of the European Parliament and
of the Council on compulsory licensing for crisis management and
amending Regulation (EC) 816/2006

Delegations will find attached document SWD(2023) 122 final.

Encl.: SWD(2023) 122 final

8901/23 ADD 5 BM/ps
## COMPET.1 EN

EUROPEAN

COMMISSION

Brussels, 27.4.2023
SWD(2023) 122 final

**COMMISSION STAFF WORKING DOCUMENT**

**EXECUTIVE SUMMARY OF THE IMPACT ASSESSMENT REPORT**

_**Accompanying the document**_

**Proposal for a Regulation of the European Parliament and of the Council**

**on compulsory licensing for crisis management and amending Regulation (EC) 816/2006**

{COM(2023) 224 final} - {SEC(2023) 173 final} - {SWD(2023) 120 final} 
{SWD(2023) 121 final}

# **EN EN**

1
[IP action plan, COM(2020) 760 final, 25.11.2020.](https://ec.europa.eu/info/law/better-regulation/have-your-say/initiatives/13357-Intellectual-property-revised-framework-for-compulsory-licensing-of-patents_en)
2 The resolution on the IP action plan to support the EU’s recovery and resilience (2021/2007(INI)).
3 Council conclusions of 18 June 2021.
4 [Proposal](https://single-market-economy.ec.europa.eu/document/d1d0b38a-cec8-479d-be70-1ffae7e227a5_en) for a regulation of the European Parliament and of the Council establishing a Single Market
[emergency instrument (SMEI) and repealing Council Regulation No (EC) 2679/98, Regulation (EU) 2022/2371](https://eur-lex.europa.eu/legal-content/EN/TXT/?uri=uriserv%3AOJ.L_.2022.314.01.0026.01.ENG&toc=OJ%3AL%3A2022%3A314%3AFULL)
of 23 November 2022 on serious cross-border threats to health and repealing Decision No 1082/2013/EU and
[Council Regulation](https://eur-lex.europa.eu/legal-content/EN/TXT/?uri=uriserv%3AOJ.L_.2022.314.01.0064.01.ENG&toc=OJ%3AL%3A2022%3A314%3AFULL) (EU) 2022/2372 of 24 October 2022 on a framework of measures for ensuring the supply of
crisis-relevant medical countermeasures in the event of a public health emergency at Union level

1

2

3

|Patent owners|(+ +) Lower costs of negotiations, due to a single procedure at EU level instead of multiple procedures in each EU<br>country concerned.<br>(+ +) More legal certainty (e.g. clarity on what level of remuneration may be expected), due to the single procedure at<br>EU level instead of multiple procedures in each country concerned.|
|---|---|
|Manufacturers– <br>potential licensees|(+ +) Lower costs of negotiations, due to the single procedure at EU level.<br>(+) Lower costs of adapting manufacturing facilities to the production of the item(s) covered by the licence, due to<br>economies of scale, if EU-level compulsory licensing leads to wider geographical scope.|
|EU countries|(+ + +) Significantly lower costs of running the compulsory licensing procedure (no negotiations with the patent<br>holders or manufacturers), as EU countries will only implement a single decision made at EU level<br>(+) Better exchange of information about availabilities of product(s), in case of local shortages or cross-border value<br>chain disruptions.<br>(+) Better decision-making and cooperation in the context of compulsory licencing for export to non-EU countries.|
|The general public<br>(EU citizens)|(+ + +) Significantly lower risk of delays or unavailability of critical products during crisis, as rules are consistent<br>across all EU countries_._|

4

|Patent owners|(- -) In the event of a broader geographical scope for the licence (= wider loss of control over patent rights).|
|---|---|
|EU countries|(-) Cost of participating in the advisory committee assisting the single contact point_._ <br>(-) Cost of reporting to the European Commission on the implemented compulsory licence.|

5

6