Since the outbreak of the COVID-19 pandemic, Italy has played a proactive role in international initiatives aimed at countering health threats.[1] The Italian strategy in the fight against the pandemic was pursued through cooperation in different multilateral fora. Firstly, Italy participated in multilateral efforts undertaken within the World Health Organization (WHO), the European Union (EU) and the G20 and supported initiatives to reform global health law through the adoption of a new binding instrument on pandemic preparedness and response. Furthermore, Italy committed to ensuring the success of international procurement mechanisms for vaccines’ supply to low- and middle-income countries and advocated for exemptions to the international patent system to increase vaccines’ production.
In 2021, during the 74th World Health Assembly, Italy confirmed its involvement in the works of the WHO by expressing support for multilateral solutions within the Organization.[2] In particular, the Italian Government endorsed the European proposal for a new binding instrument on pandemic preparedness and response, discussed within the special session of the World Health Assembly held at the end of November 2021.[3] In light of the findings of the Working Group on Strengthening WHO Preparedness and Response to Health Emergencies,[4] the Organization’s Member States agreed on that occasion to establish the Intergovernmental Negotiating Body to draft a WHO agreement or another international instrument on pandemic prevention, preparedness and response.[5] As of May 2022, negotiations and open consultations are ongoing, and their results are meant to lead to the adoption of an agreed text by 2024.
The engagement of the Italian Government in multilateral health cooperation was also proven by the Italian Presidency of the G20. Within this mandate, Italy co-organized, in partnership with the European Commission, the Global Health Summit, which was held in Rome in May 2021. This meeting led to the adoption of the “Declaration of Rome”,[6]which established 16 Principles concerning the support for and promotion of multilateral actions for strengthening the global health architecture. In September 2021, still during Italy’s G20 Presidency, the Country hosted a meeting of the G20 Health Ministers, during which the “Declaration of the G20 Health Ministers” was adopted: this reiterated the G20’s efforts “to promote strong multilateral cooperation, including towards ending the COVID-19 pandemic and supporting recovery, and to continue contributing with our joint efforts to better prevent, detect and respond to global health risks and emergencies”.[7]
As for Italy, such efforts include its participation, since 2020, in the activities of the so-called “Team Europe” for the development of an international cooperation mechanism, called “Access to COVID-19 Tools Accelerator”.[8] This was established in collaboration with the WHO, the Global Vaccine Alliance, the Coalition for Epidemic Preparedness Innovations, the United Nations Children’s Fund and other organizations, and includes also the COVID-19 Vaccines Global Access (better known as COVAX) initiative for direct sharing of vaccine doses with low- and middle-income Countries.
In 2021, Italy increased its financial participation in the initiatives of Team Europe, which committed to donating 700 million doses to COVAX by mid-2022, considering this contribution as an integral part of the European vaccine strategy.[9] In addition, Italy participated in the EU vaccine-sharing mechanism, to provide EU-purchased doses to third Countries, and was involved in the Member States’ bilateral donation plans to deliver further vaccines doses.[10]
A crucial dimension of the Italian strategy for the production of vaccines in, and their supply to, Countries in need also includes proposals concerning both the temporary suspension of patents and intellectual property rights as well as the granting of compulsory licenses. The Italian Parliament debated motions on these issues, mainly in view of the Prime Minister’s participation in the meetings of the European Council, to make the parliamentary proposals known at the European level. Already on 2 December 2020, for instance, the Chamber of Deputies (437th Meeting, XVIII Legislature) approved Resolution No. 6-00158 committing the Government to advocating, within the EU, for the World Trade Organization (WTO) to waive the ordinary regime on patents or other intellectual property rights so as to ensure free access to COVID-19 vaccines. But the two houses of the Parliament reiterated and expanded this position during 2021.[11] Most notably, on 24 March the Government endorsed Motion No. 1-00423 (reworded), passed by the Chamber of Deputies at its 474th Meeting (XVIII Legislature) and committing the Government itself to
continuing its efforts at the European level to support the instruments of international solidarity towards third Countries and in particular the vulnerable ones, starting with the COVAX Facility, to ensure fair and effective access to vaccines on a global scale, without undermining the highest credibility and priority of the Union towards its citizens, who must be granted access to vaccine as quickly as possible;
working within the framework of the European Union and the WTO to ensure that the multilateral trade system based on rules, including the flexibilities provided by the TRIPs Agreement, can fully support universal and equitable access to COVID-19 vaccines and treatments. In this context, working within the European Union so that the WTO can temporarily derogate, for COVID-19 vaccines, from the ordinary regime of the TRIPs Agreement on patents or other intellectual property rights, taking into account the balance between the protection of intellectual property and widespread universal access [sic] to anti-COVID-19 vaccines and drugs, with the aim of providing a robust and rapid response to the pandemic;
acting within both the EU and the WTO to find solutions that facilitate collaboration with the pharmaceutical industry in order to increase the worldwide production capacity of COVID-19 vaccines, through licensing agreements also with a view to exporting the vaccines to any low- and middle-income Countries without production capacity […].
The motion refers, albeit in a generic manner, to the Agreement on Trade-Related Aspects of Intellectual Property Rights (TRIPs), which provides for the rules governing the suspension of patents in the event of public health emergencies by granting compulsory licenses. More specifically, according to Articles 31 and 31bis of the TRIPs Agreement, WTO Members may resort to the compulsory licensing system to allow non-patent companies to produce and export patented vaccines upon payment of adequate remuneration to the company owning the intellectual property, taking into account the economic value of the authorization (letter (h) of Article 31bis). Moreover, Article IX(3)-(4) of the Marrakech Agreement establishing the WTO allows for a temporary suspension of an obligation deriving from participation in the Organization, including those contained in the TRIPs Agreement concerning copyright, industrial designs, patents and the protection of non-shared information. However, the requirement is that there must be a justification based on exceptional circumstances and that the terms, including time limits, of such suspension must be made explicit.
Pleas along these lines have been repeatedly endorsed by the President of the Council of Ministers, Mr. Mario Draghi, before the European Council, as demanded by the Parliament through the adoption of specific resolutions. Significantly, in December 2021, the Chamber of Deputies (615th Meeting, XVIII Legislature) and the Senate of the Republic (387th Meeting, XIII Legislature) adopted two twin resolutions, Nos. 6-00200 and 6-00202 respectively, to commit the Italian Government to
promoting international solidarity and further intensifying investment in vaccines, including by expediting the transfer of vaccines through the COVAX program, for the benefit of low- and middle-income Countries, while working in all European and multilateral fora for a temporary derogation for anti-COVID-19 vaccines from the ordinary TRIPs Agreement regime on patents or other intellectual property rights, including the transfer of the necessary know-how […].
Accordingly, as provided for by the Budgetary Law for the year 2022 and the multiannual budget for the period 2022-2024,[12] the Italian participation in initiatives related to vaccine cooperation through the existing multilateral instruments is expected to increase in terms of funds and doses. In this respect, during the examination of the bill, the Government expressed support for a motion (ordine del giorno), named G/2448/1/5,[13] committing the Government itself to
considering the opportunity to strengthen the health initiatives conducted by Italy, to ensure the equitable distribution of vaccines as well as diagnostic and therapeutic equipment against COVID-19, through the existing multilateral bodies – Access to COVID-19 Tools Accelerator and COVAX Facility – and by promoting the launch of new projects for the strengthening of health systems in the African continent, also in the bilateral dimension, possibly to be carried out in collaboration with NGOs and associations operating in the field, which can help accelerate the vaccination campaigns against COVID-19 of the local population.
Besides, on 18 November 2021, the Committee on Foreign Affairs, Emigration (3rd) of the Senate (127th Meeting, XVIII Legislature), in approving its report on the budget estimate of the Ministry of Foreign Affairs and International Cooperation for the financial year 2022 and the period 2022-2024, favorably assessed the Budgetary Law but called for the intensification of the national effort to vaccinate, with particular regard to African Countries, in addition to the funds already pledged by Italy to the COVAX initiative.
Further developments on this topic are expected in the near future also from the Extraordinary Commission on Human Rights of the Senate which, in April 2021, was mandated to carry out explorative investigations on the subject of “allocation of more resources to the COVAX programme and recognition of vaccination as a universal right”.[14]
Ludovica Di Lullo
A quotable version of this post was published in the Italian Yearbook of International Law: Di Lullo, “International Cooperation in the Fight against Covid-19 and the Efforts for Equal Access to and Distribution of Vaccines”, IYIL XXXI (2021), 2022, pp. 517-522; available here.
[1] See also Bono, “Responsibility for the Spread of COVID-19 and Socio-economic Concerns in the Fight Against the Pandemic”, IYIL, 2020, p. 528 ff.
[2] Minister Speranza’s speech at the 74th World Health Assembly on behalf of the Italian Government is available here.
[3] World Health Assembly – second special session, Italy’s Statement, available here.
[4] World Health Assembly – second special session, Report of the Member States Working Group on Strengthening WHO Preparedness and Response to Health Emergencies to the special session of the World Health Assembly, Decision SSA2/3, 23 November 2021.
[5] World Health Assembly – second special session, The World Together: Establishment of an intergovernmental negotiating body to strengthen pandemic prevention, preparedness and response, Decision SSA2(5), 1 December 2021.
[6] Global Health Summit, Rome Declaration, 21 May 2021, available here.
[7] Declaration of the G20 Health Ministers, Rome, 5-6 September 2021, available here.
[8] European External Action Service, “‘Team Europe’ – Global EU Response to Covid-19 supporting partner countries and fragile populations”, 11 April 2020; Id., “Coronavirus: European Union launches ‘Team Europe’ package to support partner countries with more than €20 billion”, 8 April 2020; European Commission, “Team Europe contributes €500 million to COVAX initiative to provide one billion COVID-19 vaccine doses for low and middle income countries”, 15 December 2020; WHO, “The ACT-Accelerator: Two years of impact”, 26 April 2022.
[9] European Commission, “EU Vaccines Strategy”.
[10] European Commission, “Factsheet – Team Europe COVID-19 global solidarity”.
[11] See Resolution No. 6-00192 approved on 23 June by the Senate (340th Meeting, XVIII Legislature). See also Resolutions Nos. 6-00200 and 6-00202 quoted infra in the main text.
[12] Senate of the Republic, Bill No. 2448 (“Budgetary Law for the financial year 2022 and the multiannual budget for the period 2022-2024”).
[13] The text of the motion is available here.
[14] Technical information is available here.
Italy's Diplomatic and Parliamentary Practice on International Law 