The Bill on Amendments to the Medical Devices Act, the Emergency Act and Other Acts (165 SE), initiated by the Government, will bring the Medical Devices Act into conformity with European Union law. During the proceedings, the Social Affairs Committee included motions to amend the Emergency Act, the Communicable Diseases Prevention and Control Act, the Health Services Organisation Act and the Health Insurance Act, according to proposals by the Ministry of Social Affairs.
During the second reading, an amendment was voted into the Emergency Act under which, in order to resolve an emergency, the authority coordinating the resolution of the emergency may give authorities of executive power, local authorities and other public authorities orders taking into account the powers and authorities of such authorities and persons. Such orders include issue of administrative acts or performance of acts, termination of performance of acts or prohibition of performance of acts, and partial or full suspension of performance of acts.
The amendments to the Communicable Diseases Prevention and Control Act are due to the urgent need to ensure that, after the emergency situation, the Health Board will have legal clarity and security to tackle situations that may arise. The purpose of the amendments is to ensure efficient and effective prevention of the spread of communicable diseases by giving the Health Board the right to implement various requirements and measures to control viruses, based on its powers and authorities.
The directives on medical devices, active implantable medical devices and in vitro diagnostic medical devices have been regulating the field of medical devices in the European Union so far. Two new EU Regulations will be applied gradually in the future to replace them. The regulations aim to establish a more robust, transparent, predictable and sustainable regulatory framework for medical devices. This will ensure better safety of devices and a high level of health whilst supporting innovation. In connection with the application of the Regulations, the Medical Devices Act and other associated Acts need to be amended.
During the debate, Tarmo Kruusimäe (Isamaa), Peeter Ernits (Estonian Conservative People’s Party), Signe Riisalo (Reform Party), Kalle Laanet (Reform Party) and Mihhail Lotman (Isamaa) took the floor and pointed out problems and shortcomings relating to the Bill.
The Estonian Reform Party Faction moved to suspend the second reading of the Bill. The result of voting: 37 votes in favour, 47 against, one abstention. The motion was not supported. The Bill was sent to the third reading.
Another Bill passed the second reading
The Bill on Amendments to the Product Conformity Attestation Act (125 SE), initiated by the Government, will implement in Estonia the new directly applicable EU Regulation that replaces the Regulation that was in force before and concerns the mutual recognition of the conformity of goods marketed in another Member State. The Regulation helps stimulate trade in goods in the European single market and speed up and enhance the work of competent authorities in the evaluation of goods. The implementation of the new Regulation will make it simpler for Estonian economic operators to take their products to the EU market.
According to the principle of mutual recognition, products that have been placed on the market in a Member State under the rules in force there must be allowed to be freely placed on the market in EU Member States also when different requirements have been established for them in the country of destination. The Bill provides for the right of competent authorities to prohibit goods from being placed on the market and to require withdrawal of goods from the market in Estonia in pursuance of the procedure provided for in the directly applicable Regulation. Based on the Regulation, competent authorities must clearly justify restriction on market access. This can be done for example on the basis of overriding reasons of public interest, and it must be evaluated whether the restrictions are proportionate to the aim pursued.
For example, the Consumer Protection and Technical Regulatory Authority, the Health Board, the Maritime Administration, the Agricultural Board, the Environmental Inspectorate, the Road Administration and the Veterinary and Food Board will be the competent authorities on the basis of the legislation regulating the sector. In addition, the Act regulates the obligation of these authorities to exchange information with the competent authorities of other Member States.
A Bill passed the first reading:
The Bill on Amendments to the Public Procurement Act and the Commissioning of Artworks Act (177 SE), initiated by the Government, will amend the provisions regulating electronic information exchange. As a result of an amendment, suppliers will be released from the obligation of electronic information exchange in public procurements of small value, less than 30 000 euro in the case of supplies and services, and less than 60 000 in the case of works.
Under the current Act, high-security electronic exchange of information must be used in the case of every public procurement regardless of the value. The purpose of the amendment is to enable simpler electronic information exchange (e.g. by e-mail) in public procurements of smaller value whereby the workload of contracting authorities and the administrative burden of tenderers will be significantly reduced. In the case of reopening a competition on the basis of a framework agreement, the obligation of electronic information exchange would not apply where the estimated value of the public contract to be awarded is below the simple procurement threshold, that is, below 30 000 euro in the case of supplies and services. In the case of public procurements that do not fall within a simplified procurement threshold provided for by law, the obligation of electronic information exchange would apply starting from the public procurement threshold.
On the proposal of the Ministry of Culture, after the coordination with the relevant parties, an amendment has been included in the Commissioning of Artworks Act to increase the threshold that requires the commissioning of artworks in connection with contracting for works. The current threshold is 450 000 euro and will be raised to 750 000 euro. In addition, the Minister of the Environment will be given the authority to establish mandatory environmentally sound criteria in procurements to purchase furniture, cleaning products and services, office IT-equipment, and copying and graphic paper.
The Riigikogu heard replies to three interpellations
Members of the Riigikogu Hele Everaus, Urmas Kruuse, Urve Tiidus, Vilja Toomast, Ants Laaneots, Maris Lauri, Hanno Pevkur, Kaja Kallas, Erkki Keldo, Toomas Kivimägi, Jüri Jaanson, Signe Riisalo and Andrus Seeme had submitted an interpellation concerning ensuring the availability of family physician service (No. 20) to the Minister of Social Affairs Tanel Kiik.
The interpellators wished to know if the Ministry of Social Affairs had planned strategic systematic action to ensure sustainability of family medical practice in all regions of Estonia.
Kiik confirmed that the availability of primary medical care was undoubtedly a national health care organisational priority. The Ministry of Social Affairs together with the Health Board, the Estonian Health Insurance Fund and the Estonian Family Physicians’ Association is adhering to and continues to comply with the cooperation agreement jointly signed on 19 March last year which aimed to agree on objectives and actions that would be implemented in cooperation to ensure availability and development of family medical care in the coming years.
Kiik explained that, in view of the objective of the agreement, the parties met regularly within the framework of separate working groups. “I for one participate in several such meetings, in particular with representatives of the Estonian Health Insurance Fund and the Health Board and the Estonian Family Physicians’ Association, to discuss the potential needs in the service management model and the funding model, issues relating to the establishment of health care centres, the issue of working hours, as well as the issue of the mobility of doctors, and certainly the issues of new generations,” Kiik said.
He added that, as a recent noteworthy change to be pointed out, with a view to ensuring the sustainability of family medical care, an amendment had entered into force on 1 April, as a result of which the current additional remunerations to family physicians had increased by several times, and the range of the persons who received the remuneration outside Tallinn and Tartu and the municipalities bordering thereon would be extended.
Kiik said that financial motivation was just one part of the motivational package. A modern working environment, a supporting team, work offering flexible challenges, and the above-mentioned good cooperation between local governments and family physicians were equally important. By the same token, all activities directed at increasing the availability of family medical care and the quality of the family medical services agreed upon earlier, also arising from the above-mentioned agreement or the good practice agreement between the Estonian Family Physicians’ Association, the Estonian Health Insurance Fund, the ministry and the Health Board, continue.
The Minister of Social Affairs also replied to interpellations concerning care home fees (No. 30) and the unjustifiably high prices of medicinal products (No. 32).
The sitting ended at 9.41 p.m.
Video recordings of the sittings of the Riigikogu can be viewed on the Riigikogu YouTube channel.
(Please note that the recording will be uploaded with a delay.)
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