Electronic document management in Ukrainian pharmaceuticals
LEGAL BASIS FOR ELECTRONIC DOCUMENT MANAGEMENT:
The birth of EDM at the legislative level took place back in 2003, when the Law of Ukraine “On Documents and Electronic Document Management” came into force. There are a number of legal acts that regulate… but let’s not go into that much detail. It is worth knowing that today the legal basis for the implementation of EDM is usually the Law of Ukraine “On Electronic Trust Services” (hereinafter referred to as the Law), which came into force in 2018 and introduced the concept of a qualified electronic signature (QES) instead of the previous EDM.
Briefly about the QES. The legal legitimacy of the QES is laid down directly in the provisions of the Law itself, in particular:
- A QES cannot be obtained by power of attorney, only in the personal presence of the signatory;
- The legal essence of a QES corresponds to a handwritten signature with all the necessary legal consequences;
The legal legitimacy of the use of EDM in general is laid down, in particular, in Article 9 of the Law of Ukraine “On Accounting and Financial Reporting in Ukraine” dated 16.07.1999 No. 996-XIV (hereinafter – the “Accounting Law”), as well as paragraph 2.4 of the Regulation on Documentary Support of Accounting Records approved by Order of the Ministry of Finance dated 24.05.1995 No. 88 (hereinafter – Regulation No. 88), which allow for the preparation of primary documents in electronic form. However, this is subject to compliance with the requirements of the legislation on electronic documents and electronic document flow (subpara. 8 of Part 2 of Article 9 of the Law Mandatory details of primary documents are specified in Article 9 of the Law of Ukraine “On Accounting and Financial Reporting”
The law also requires that the electronic form be visualized and suitable for human perception of its content (part 4 of Article 5 of the Law of Ukraine On Electronic Documents and Electronic Document Management). Such a document is considered to be an original, and all paper reflections of this document are a copy (Article 7 of the same Law).
In conclusion, back in 2017, the SFS of Ukraine expressed its position on confirming the legitimacy and recognition of electronic documents, namely: it published a Letter on the possibility of taxpayers to maintain exclusively in electronic form documents on accounting for income, expenses and other indicators related to the determination of taxable objects (tax liabilities), primary documents, accounting registers, financial statements, other documents related to the calculation and payment of taxes and fees, the use of documents created in
HOW DOES IT WORK FOR PHARMACEUTICALS?
The pharmaceutical market is currently discussing a lot, but not everyone uses electronic document management to exchange and sign primary documents with counterparties (hereinafter referred to as EDM). Yes, some are trying to implement EDM with partners outside the pharmaceutical market, which is understandable. But what about the pharmaceutical industry? We all know that the regulatory authority has established additional requirements for information (additional columns) in the invoices for the supply of medicines; it has established the need to comply with quality control of medicines not only in practice but also in documents, etc.
So, how do you ensure that an authorized person signs each electronic invoice? What to do with additional columns? How to implement electronic documents in SOPs? What is the attitude of the State Service of Ukraine for Legal Services and the State Fiscal Service?
All of these legal difficulties can be solved, so let’s look into them.
In general, it’s clear, but what about the “primary”, in particular, the expenditure invoices for medicines? What about incoming quality control?
Regarding the latter, I would like to remind you that the Order of the Ministry of Health of Ukraine No. 677 “On Approval of the Procedure for Quality Control of Medicinal Products in Wholesale and Retail Trade” dated 29.09.2014 “On Approval of the Procedure for Quality Control of Medicinal Products in Wholesale and Retail Trade” stipulates that an authorized person of a business entity, among other things, is obliged to draw up a conclusion on the incoming quality control of medicinal products by marking the receipt invoice: “Incoming control carried out, result positive/negative, allowed/not allowed for sale, signature, full name of the authorized person, date of incoming control”.
In order to find answers, it is necessary to dive deeper into the legal essence of the current legislation.
Thus, in accordance with Article 6 of the Law of Ukraine “On Electronic Digital Signature” dated 22.05.2003 No. 852-IV (hereinafter – Law No. 852), the imposition of an electronic signature completes the creation of an electronic document. Relations related to the use of advanced and qualified electronic signatures (QES) are regulated by the Law of Ukraine “On Electronic Trust Services”. Pursuant to the same Law, a qualified electronic signature is an advanced electronic signature created using a qualified electronic signature tool and based on a qualified public key certificate.
Thus, an electronic document containing a QES has the legal force of the original document.
According to the Law of Ukraine “On Electronic Trust Services”, users of electronic trust services are signatories, creators of electronic seals, senders and recipients of electronic data, other individuals and legal entities that receive electronic trust services from providers of such services in accordance with the requirements of this Law. Thus, we come to the conclusion that the definition does not indicate that users can be exclusively directors of enterprises, but can also be other employees of the enterprise duly authorized to perform the relevant functions. Such signatories may also include authorized persons for quality control of medicines in pharmacies.
Providers of electronic trust services from a legal entity applicant, among other things, request copies of documents confirming the applicant’s affiliation (except for the director) with a legal entity and his or her powers (order/extract from the order of appointment to the position, or employment contract), which once again confirms the position of the Law.
You may ask, what about the licensing authority, the State Service of Ukraine on Medicines and Drugs Control? I would like to point out that according to the Regulation
on the State Service of Ukraine on Medicines and Drugs Control, the State Service is guided by the Constitution and laws of Ukraine in its activities… the legislation on the use of EDI by licensing entities is no exception https://zakon.rada.gov.ua/laws/show/647-2015-п
Further,
according to the Order No. 677, additional requirements for the expenditure invoice for medicinal products are defined, where, among other data, it is necessary to indicate
- name of the medicinal product
- dosage
- dosage form
- the batch number of the medicinal product;
- expiration date of the drug;
- quantity of the medicinal product;
- name of the manufacturer.
This remains a matter of technical implementation of additional regulatory requirements. There are already more than enough software solutions for implementing EDM on the market, they allow you to change the forms of template documents and adapt them to the forms of invoices for the sale of medicines. However, probably the biggest problem with the introduction of EDM is the availability of a variety of software products that can work with electronic primary source documents, since there is not always the possibility of data exchange between different programs. But I am sure that solving this problem is a matter of the very near future.
As for the formation of the QES, according to the Law of Ukraine “On Electronic Trust Services”, it is carried out by electronic trust service providers. A qualified electronic trust services provider is a legal entity regardless of its organizational and legal form and form of ownership, an individual entrepreneur who provides one or more electronic trust services, whose activities comply with the requirements of the Law of Ukraine “On Electronic Trust Services” and whose information is included in the Trust List – https://czo.gov.ua/trustedlist.
Finally, the EDM is absolutely correlated with all good practices (GDP, GMP) and the License Terms not only in relation to invoices, but also other documents accompanying medicinal products and required to be exchanged and stored by licensees. In particular, clause 26 of the Licensing Conditions for the Conduct of Business Activities for the Manufacture of Medicinal Products, Wholesale and Retail Trade in Medicinal Products, Import of Medicinal Products (except for active pharmaceutical ingredients) provides for the possibility of a business entity to keep copies of the manufacturer’s and/or importer’s quality certificates for a series of medicinal products, including on electronic media. In support of our position, I would like to note that we have already received a positive response from the State Service of Ukraine on Medicines and Drug Control regarding the possibility of using EDM and QCS for our client.
The main thing is the correct legal implementation/adoption of EDM in a pharmaceutical company. In this case, it is important to turn to specialists who have experience in the pharmaceutical industry in general and in the implementation of such processes in particular.
Or, you can always leave everything as it is and:
- create multi-story archives of paper documents;
- to bear financial risks due to the absence or incorrectness of the “primary source”;
- not be able to defend their financial interests in court.