On 30 July 2020, the World Trade Organization (WTO) convened a formal meeting of the TRIPS Council. The TRIPS Council held discussions on two COVID-19 related topics: agenda item 3 on IP Measures in the Context of COVID-19 and agenda item 14 on Intellectual Property and the public interest: Beyond Access to Medicines and Medical Technologies Towards a More Holistic Approach To TRIPS Flexibilities.
The European Union delivered the following general statement on COVID-19.
ITEM 3 – IP MEASURES IN THE CONTEXT OF THE COVID CRISIS
It is clear that broad and equitable access to existing and new treatments, and ultimately vaccines, will be key to tackle the present public health crisis, including for developing countries that have no production capacities or more limited financial resources. The EU will provide more comments on this crucial issue under item 14 of the agenda.
The EU notified two IP measures that were taken in the context of the COVID-19 pandemic. Measures were also notified by Germany, Hungary, Italy and Greece.
The European Union Intellectual Property Office has extended the deadlines for trademark and design matters. This decision concerned all time limits in each proceedings before the EUIPO that would have expired between 9 March and 30 April.
The European Committee for Standardization and the European Committee for Electrotechnical Standardization, in collaboration with their members, agreed to make freely available certain copyrighted European standards for certain medical devices and personal protective equipment.
An amendment to the German Act on the Prevention and Control of Infectious Diseases in Humans granted the German Parliament the competence to determine the existence of an ‘epidemic situation of national significance’. In such a situation, the Federal Ministry for Health (instead of the Cabinet) is authorised to issue orders under the German Patent Act, allowing faster proceedings.
The Italian Patent and Trademark Office has extended the deadlines for administrative proceedings for trademarks, patents, designs and models.
Greece also notified measures related to time limits in IPR administrative procedures.
Hungary notified its new legislation on compulsory licenses also under the COVID-19 measures.
As the crisis persists, the situation is dynamic and additional notifications can be expected, especially as regards deadlines for administrative proceedings related to intellectual property rights.
On a separate agenda item on Member notifications under provisions of the TRIPS Agreement, the European Union provided the following details on developments in Hungary.
The notified Government Decree on public health compulsory licences for exploitation within Hungary created the possibility to issue a public health compulsory licence for exploitation within Hungary. The Government Decree laid down the preconditions to issue a compulsory licence in an emergency public health situation, like the current COVID-19 pandemic. The Government Decree implements Art 31 of the TRIPS Agreement. The Government Decree ceased to have effect and its content was incorporated into Hungary’s patent law. Hungary notified also another law that amended the mentioned provisions.
The European Union provided the following response to South Africa’s proposal on a more holistic approach to TRIPS flexibilites.
ITEM 14 INTELLECTUAL PROPERTY AND PUBLIC INTEREST: BEYOND ACCESS TO MEDICINES AND MEDICAL TECHNOLOGIES TOWARDS A MORE HOLISTIC APPROACH TO TRIPS FLEXIBILITIES
THE EU WOULD LIKE TO THANK SOUTH AFRICA FOR INTRODUCING THIS AGENDA ITEM.
THE WORLD QUICKLY NEEDS TO DEVELOP AND DEPLOY EFFECTIVE DIAGNOSTICS, SAFE AND EFFECTIVE TREATMENTS AND VACCINES, WHICH ARE AVAILABLE AND ACCESSIBLE EVERYWHERE, AT AN AFFORDABLE PRICE. THIS IS THE ONLY WAY TO MAKE SURE WE CAN JOINTLY DEFEAT THE VIRUS.
IT IS CLEAR THAT BROAD AND EQUITABLE ACCESS TO EXISTING AND NEW TREATMENTS, AND ULTIMATELY VACCINES, WILL BE KEY TO TACKLE THE PRESENT PUBLIC HEALTH CRISIS, INCLUDING FOR DEVELOPING COUNTRIES THAT HAVE NO PRODUCTION CAPACITIES OR MORE LIMITED FINANCIAL RESOURCES.
IT IS WITH THIS OBJECTIVE IN MIND THAT THE EU HAS LED “THE CORONAVIRUS GLOBAL RESPONSE” PLEDGING INITIATIVE WITH THE WHO AND GLOBAL PARTNERS TO ACCELERATE THE DEVELOPMENT, PRODUCTION AND DEPLOYMENT OF VACCINES, DIAGNOSTICS AND THERAPEUTICS, AND TO STRENGTHEN NATIONAL HEALTH SYSTEMS AGAINST COVID-19. THE EU HAS ALSO LED THE WORK ON A RESOLUTION ON COVID-19 RESPONSE, ADOPTED BY THE 73RD WORLD HEALTH ASSEMBLY ON 19 MAY 2020. THIS RESOLUTION REPRESENTS A STRONG COMMITMENT OF THE GLOBAL COMMUNITY TO INTERNATIONAL COOPERATION IN FIGHTING THE PANDEMIC AND ENSURING ACCESS TO COVID-19 TREATMENTS AND VACCINES.
GLOBAL CO-OPERATION IS ESSENTIAL TO ACCELERATE THE DEVELOPMENT AND SCALE-UP THE PRODUCTION OF SAFE, EFFECTIVE, QUALITY DIAGNOSTICS, MEDICINES AND VACCINES FOR THE COVID-19 RESPONSE, INCLUDING THROUGH ARRANGEMENTS WITH INDUSTRY AND EXISTING MECHANISMS FOR VOLUNTARY POOLING OF RIGHTS AND LICENSING.
POOLING OF RIGHTS AND OTHER VOLUNTARY LICENSING ARRANGEMENTS ALLOW TO ACCELERATE THE DEVELOPMENT OF DIAGNOSTICS, MEDICINES AND VACCINES FOR COVID-19 AND SCALING UP THEIR PRODUCTION. THESE MECHANISMS BENEFIT EVERYONE AS THEY DRIVE BOTH ACCESS AND INNOVATION.
THE TRIPS AGREEMENT PROVIDES VARIOUS AVENUES TO ADDRESS POTENTIAL IP MATTERS IN THE CASE OF HEALTH EMERGENCIES SHOULD VOLUNTARY MECHANISMS FAIL, NOT ONLY WITH REGARD TO PATENTS, BUT ALSO WITH REGARD TO OTHER IP RIGHTS. THESE INCLUDE GENERAL CLAUSES ON EXCEPTIONS OR PROVISIONS ON COMPULSORY LICENSING.
IN THE EUROPEAN UNION THESE PROVISIONS ARE IMPLEMENTED EITHER AT REGIONAL OR NATIONAL LEVEL. FOR EXAMPLE, THE AREAS OF COPYRIGHT, TRADEMARKS, DESIGNS AND TRADE SECRETS ARE LARGELY HARMONISED AT REGIONAL LEVEL, INCLUDING PROVISIONS ON EXCEPTIONS AND LIMITATIONS. ON THE OTHER HAND, THE GRANTING OF COMPULSORY LICENCES IN THE AREA OF PATENTS IS REGULATED AT NATIONAL LEVEL – EACH EU MEMBER STATE HAS RELEVANT LEGISLATION AND IS ABLE TO ISSUE A COMPULSORY LICENCE AT NATIONAL LEVEL.
THE EU HAS CONSISTENTLY SUPPORTED THE USE, WHERE NECESSARY AND JUSTIFIED, OF THE FLEXIBILITIES PROVIDED UNDER THE TRIPS AGREEMENT AND THE DOHA DECLARATION WITH THE OBJECTIVE OF ENSURING EFFECTIVE ACCESS TO MEDICINES.
WE ALSO RECALL THAT THE TRIPS COUNCIL SECRETARIAT HAS, REGULARLY AND CONSISTENTLY, OFFERED ITS SERVICES TO ANY WTO MEMBER THAT SEES ITSELF IN THE NEED OF GETTING HELP TO MANAGE THE PROCESS OF ARTICLE 31BIS OF THE TRIPS AGREEMENT.
THE INNOVATION MODEL, BASED ON PATENTS, HAS DELIVERED CONSISTENT PROGRESS IN GLOBAL PUBLIC HEALTH, CONTINUOUSLY LEADING TO IMPORTANT NEW AND IMPROVED TREATMENTS AS WELL AS MUCH EXTENDED LIFE EXPECTANCY, TACKLING THE GLOBAL HEALTH CHALLENGES HUMANITY FACED SO FAR. THE EU CONSIDERS THAT ON THE BASIS OF THE CURRENT SYSTEM, WITH THE NECESSARY IP TOOLS AND ARRANGEMENTS IN PLACE, EXISTING AND NEW TREATMENTS, AND ULTIMATELY VACCINES, CAN BE MADE AVAILABLE AND EFFECTIVELY DEPLOYED RAPIDLY ACROSS THE GLOBE.
A WELL-FUNCTIONING ECOSYSTEM FOR THE PROTECTION AND ENFORCEMENT OF INTELLECTUAL PROPERTY RIGHTS REMAINS A CRUCIAL INCENTIVE FOR INNOVATION, THE RESEARCH AND DEVELOPMENT OF NEW VACCINES, MEDICINES AND TREATMENTS.
LET US ALSO RECALL THAT EVIDENCE SHOWS THAT INDEED THERE ARE MANY DIFFERENT SIGNIFICANT CAUSES OF LACK OF ACCESS TO MEDICINES. IT IS NO DIFFERENT IN THE CASE OF COVID-19. THERE ARE NO SIMPLE SOLUTIONS TO THE CURRENT CRISIS. WE NEED THE NECESSARY EXPERTISE IN PRODUCTION OF NEW TREATMENTS OR VACCINES, WE NEED SUFFICIENT MANUFACTURING CAPACITY AND ACCESS TO RESOURCES NEEDED TO PRODUCE SUCH TREATMENTS OR VACCINES.
IT IS THE VIEW OF THE EUROPEAN UNION THAT IN ORDER TO ENSURE EQUITABLE AND AFFORDABLE ACCESS TO THE REQUIRED TREATMENTS AND VACCINES, WE MUST WORK COLLABORATIVELY WITH INDUSTRY AND WITH EACH OTHER, INCENTIVISE INNOVATIVE SOLUTIONS TO COVID-19, RAMP UP MANUFACTURING CAPACITY AND POOL RESOURCES.
THERE IS ANOTHER ASPECT IN THE FIGHT WITH COVID-19 THAT WE WOULD LIKE TO HIGHLIGHT IN THIS DISCUSSION.
A REPORT BY EUROPOL TITLED ‘VIRAL MARKETING – COUNTERFEITS, SUBSTANDARD GOODS AND INTELLECTUAL PROPERTY CRIME IN THE COVID-19 PANDEMIC’ SHOWS THAT ORGANISED CRIME GROUPS QUICKLY ADAPT TO THE NEW TRADE ENVIRONMENT AND FIND THEIR WAY TO INFILTRATE THE LEGITIMATE SUPPLY CHAIN OF PHARMACEUTICAL PRODUCTS AND EQUIPMENT. A STUDY OF THE EUROPEAN UNION INTELLECTUAL PROPERTY OFFICE AND THE ORGANISATION FOR ECONOMIC COOPERATION AND DEVELOPMENT ON TRADE IN COUNTERFEIT PHARMACEUTICAL PRODUCTS SHOWS THE ECONOMIC AND SOCIAL COSTS OF TRADE IN FAKE MEDICINES AND THE THREAT TO PUBLIC HEALTH.
THE SURGE IN DEMAND FOR ANTI-COVID-19 PRODUCTS POSES HEIGHTENED RISKS TO PUBLIC HEALTH, BECAUSE FAKE AND SUBSTANDARD PRODUCTS, SUCH AS UNPROVEN AND FAKE TREATMENTS, TEST KITS AND MEDICAL EQUIPMENT AND SUPPLIES – MASKS, VENTILATORS, GLOVES, ETC. – HAVE FLOODED THE MARKET AND THIS IS BOUND TO GET WORSE WHEN THE NEW COVID-19 TREATMENTS AND VACCINES WILL BE AVAILABLE.
DUE TO THE GLOBAL NATURE OF THESE CRIMES, GLOBAL COOPERATION IS NECESSARY.
PUBLIC HEALTH IN LIGHT OF THE PANDEMIC IS A CLEAR AND UNDISPUTED PRIORITY. NO EFFORT MUST BE SPARED TO OBTAIN EFFECTIVE AND AFFORDABLE TREATMENT, VACCINES, TESTS AND MEDICAL DEVICES NECESSARY TO FIGHT THIS PANDEMIC AND TO ENSURE THAT THESE PRODUCTS ARE SAFE FOR OUR CITIZENS. THESE EFFORTS HAVE TO BE SUSTAINED FOR AS LONG AS NEEDED.