European Rules of Registration of Medicines. Two Ways for Ukraine

- Illya Kostin, attorney-at-law, patent attorney, Head of Pharmaceutical Law Committee of Ukrainian Bar Association, partner of Legal Alliance Company

- Natalia Modlenko, associate with Legal Alliance Company, member of Ukrainian Bar Association.

Harmonization of conditions for admission of pharmaceutical products to the EU is not just a "tick" to be done while working on adaptation of Ukrainian legislation to the EU standards.

It has been repeatedly written about the difference in the cost of medicines in Ukraine and the EU, however, unfortunately, not in our favour.

What is the reason for this? And, respectively, what can be done to improve the situation?

In our country a prerequisite for releasing medicinal products on the market is their state registration, during which conformity of quality, efficacy and safety to the established requirements is verified.

The procedure for examination of documents submitted by applicants depends on the type of medicinal products (original, generic, biological, botanical, etc.) The decision on state registration is made by the Ministry of Health of Ukraine in accordance with the recommendations of a specialized expert agency.

In general the procedure for state registration and re-registration in Ukraine is a long and complex process. It differs significantly from the model employed in the EU.

Two European paths

Directive 2001/83/EC and Regulation 726/2004 of the European Parliament and of the Council of the EU are fundamental documents in this area in the EU. They govern the procedure to obtain authorization to enter the market (analogue of a marketing authorization in Ukraine), to obtain a license for manufacture and import, wholesale trade in medicinal products, as well as control over the trade, including pharmacovigilance, etc.

First of all, it should be noted that most of the acts of the EU are the minimum requirements that Member-States undertake to implement.

However, in order to provide the population with quality, effective, safe and affordable medicinal products, national laws may introduce more stringent requirements. The objective should be achieved by means which do not hinder the development of the pharmaceutical industry and trade.

Single market of the EU provides for the existence of two parallel interconnected schemes of issuing the authorization to enter the market: centralized and decentralized.

Evaluating the pros and cons of both schemes, applicants should decide which way is more optimal for them.

Statistics show that under the centralized procedure authorizations are granted both for original and generic medicinal products. Original medicines occupy a significant niche here. A separate group of medicines under special attention are medicinal products used in paediatrics.

The decentralized procedure implies that in each EU country there is a competent authority which evaluates material dossier and issues authorizations.

In some countries, one public agency is charged with the two functions, in others a separate agency evaluates the documents.

If there is no reason to believe that a medicine may pose a risk to public health, the authorization to enter the market issued in one EU country is recognized by the competent authorities of the other countries of the community.

It should be noted that in the EU countries competent authorities must make regular reports for the public on the evaluation of medicinal products. The reports are published.

In addition to the procedures for granting access to the market, the European Medicines Agency issues authorizations to enter the market, imposing provisional commitments on the applicant, which are as follows: to notify the competent authorities of all events associated with the use of the medicinal product and measures taken in connection therewith. Such authorization may be granted only for objective and due reasons.

Which model is for Ukraine to choose?

Model of state registration of medicinal products which is as close as possible to the EU standards has been proposed by the new draft Law of Ukraine "On Medicinal Products" registered in the Parliament on February 17^th, 2015 under No. 2162. The document is the result of long-term balanced work of the pharmaceutical industry experts. However, its adoption has been postponed indefinitely.

Pursuant to the commitments made by Ukraine under the EU-Ukraine Association Agreement, the bill contains a number of norms governing access to the market for and circulation of blood and plasma medicinal products. The concept of the new law wording provides for the approval of some orders, criteria, procedures, etc. by orders of the Ministry of Health of Ukraine.

Such an approach is consistent with the experience of many countries in Europe, which, given national peculiarities, implemented the requirements of Directive 2001/83/EC.

At the preparation of the bill it is taken into account that today Ukraine is not yet a full-fledged member of the EU, and European approaches to regulation are only being formed. The bill is the first step towards deep and close integration of Ukraine into the EU. It does not exclude the fact that a new law will be adopted in 3-4 years and will be aimed at greater harmonization of legislation in the field of pharmacy.

We hope that when People’s Deputies start the new session of the Verkhovna Rada of Ukraine, the document will be submitted to the Committee on Health for consideration.

However, the bill does not solve all the problems.

An important point is that not all rules of the EU market can be unconditionally adopted in the Ukrainian realities.

This applies, in particular, to the requirement that holders of marketing authorizations must possess resident status. In the EU such a norm means completely different thing, since it refers to the residents of all 28 states (and not each separate country).

For Ukraine, transfer of such standards before joining the EU would mean restricting the number of marketing authorization holders exclusively to persons registered in our country

The need to expand the list of countries which produce results of manufacturing sites inspection for compliance with Good Manufacturing Practice recognized by Ukraine also has long been debated in the pharmaceutical market.

For the time being, receipt and regular confirmation of GMP compliance certificate in Ukraine is an additional barrier to market access for medicinal products, quality of which has been confirmed by the competent authorities of foreign countries.

As trust in the competent authorities of different countries differ, the way to settle the situation in our country may be cancellation of the requirement to re-inspect those manufacture facilities which have successfully passed verification conducted by supervisory authorities in countries with stringent regulatory policy.

Exporter issue

A similar situation of medicines quality control duplicating occurs when importing goods as well.

As you know, there are two parallel procedures: licensing of medicinal products importation introduced with the purpose of harmonization with European legislation, and issuing of opinions on the quality of medicinal products batches imported into the territory of Ukraine issued by the State Service of Ukraine on Medicinal Products. It is worth noting that a part of the finished medicinal products are exempted from mandatory laboratory testing as a part of the state quality assurance.

At the same time such a procedure of state control over quality of medicinal products as a test of every batch is not typical for European countries.

The way out of the situation could be a complete transition from state import control model to the model of laboratory control by importers.

State control in this model can be carried out within the framework of scheduled and unscheduled inspections of business entities.

Transition period for Ukraine

So now we can only approximate our legislation as much as possible to European standards. It can be done, for example, by entering into agreements with European countries on mutual recognition of results of examination of registration materials, industrial sites inspection results, and similar.

With this view, on May 31^st, 2016 the Verkhovna Rada adopted the whole draft Law "On Amendments to Article 9 of the Law of Ukraine "On Medicinal Products "on Simplification of State Registration of Medicinal Products" (No. 4484).

The document provides for a simplified state registration of medicinal products registered in the United States, Switzerland, Japan, Australia, Canada, and medicinal products registered by the competent EU agency under the centralized procedure for use in the territory of these countries or the EU Member-States, respectively. The procedure for registration of such medicines requires filing a smaller set of documents, reducing the registration term (17 working days) and no expert examination of registration materials.

This model does not correspond to the European approach, but for Ukraine it is a transitive one, which will allow under a simplified procedure for filling the country market with medicines, the effectiveness of which is verified by the competent authorities of countries with stringent regulatory policies.