Positions

AT THE ATTENTION OF

DR. DANIELA DARITKOVA-PRODANOVA, MD

CHAIRPERSON OF THE HEALTHCARE COMMITTEE

44th NATIONAL ASSEMBLY

REPUBLIC OF BULGARIA

№208/08.01.2017

 EGARDING: Law on Amendment and supplementation of the Law on Medicinal Products in Human Medicine (LMPHM) - Export of Medicinal Products section

HONORABLE DR. DARITKOVA,

I present to your attention the Bulgarian Association for Medicines Parallel Trade Development (BAMPTD) Statement on the envisaged legal norms in the Law on Amendment and supplementation of the LMPHM, adopted by the Council of Ministers on 13.11.2017 and concerning the Parallel Export of Medicinal Products.

First of all, I would like to express BAMPTD Management Board members' reverence to your legislative competence and your active role, dedicated to further development of enhanced transparency and objectivity of the draft law aiming stronger public interest defense. We welcome the following innovations in the Law on Amendment and Supplementation of the LMPHM:

- The first attempt lack and shortage of medicinal products on the territory of the country to be defined

- The introduction of electronic and timely notification of BDA by the participants in the drug supply chain

- The provision of stricter drug supply chain offenders’ sanctions

- The establishment of unified specialized electronic system collecting and analyzing lack and shortage of medicinal products information on the territory of the country

BAMPTD fully supports Bulgarian patients' rights and interest protection regarding the unhindered access to medicines at the best possible price and we have repeatedly appealed a transparent, objective and non-discriminatory regulatory basis for all economic entities.

Along with the draft law merits, we would like to highlight a few facts that would be problematic:

- The Law on Amendment and Supplementation of the LMPHM texts are not identical to those, notified to the European Commission in 2016 by the team of Health Minister Petar Moskov. The current draft law cannot be treated notified to the European Commission and failure to comply with the notification procedure may lead to the respective negative consequences for our country.

- The export arrangements and regulations still do not protect the public interest from possible lack or shortages of medicines for the following reasons:

• A disproportionate export restriction is introduced. Under Bulgarian law, this constitutes unequal treatment of business entities. The certain trader per definite product export limitation imposition puts this entity at a disadvantage regarding the competitors, who at the same time are not limited to exporting the same product. According to the European regulations and the case-law of the European Court of Justice on their application, the specific lack / shortage of a product in a single trader is not a national market lack or shortage, while all other supply chain entities may have sufficient quantities of the same product. Market lack / shortage may be due to a variety of reasons - lack of import, production problems, etc.
• It is not clear whether the provision of Art. 217b, para 10 shall apply to all distributors or only to the one to whom the export limitation order has been issued.
• The obligation to sell the medicines intended for export in the country is a free movement of goods impediment and direct state interference in the free economic initiative. In case of an export prohibition order, the wholesaler must distribute the medicine on the national market, which in practice may be unenforceable, as the trader does not have to have any stock before the notification deadline expires.
• The establishment of a single electronic stock monitoring system in the drug supply chain is admired by BAMPTD, but it should be based on measurable lack and shortage of medicinal products criteria based on unified input data and comparable time periods - which in the proposed texts is not observed.
• The lack and shortage of medicinal products definitions are vague, inconclusive and immeasurable, which is an obstacle to their implementation as analytical reference element through the single electronic system for stocks monitoring in the drug supply chain.
• The monitored medicines list establishment under Art. 217c, para 3, based on the medicinal products, comprising the Positive Medicines List (PML), for which BDA have received export notifications in the last 3 months, would be unrealistic as it would contain intentions to export medicinal products rather than certain export. In this regard, the actual one-month export information distributors will submit within Art. 217b, para 9 meaning would be much more suitable as a list of monitored medicines.
• Last but not least, the limitations scope and process are set only for wholesalers, while within the scope of Art. 217a (2) a marketing authorization holder may export its medicinal products being not a subject to control.

We also bring to you our suggestions for additional norms in the Law on Amendment and Supplementation of the LMPHM:

• Establishment of a European Economic Community fast-delivery of medicinal products mechanism regulation in case of lack and shortage as well as in case of objective impossibility of the MAH to provide the same medicinal products for the Bulgarian market.
• Establishment a regulation an export restricted medicinal products automatically to be excluded of the list on a monthly basis, because as a result of the export ban, the shortage will be overcome. The draft law envisaged mechanism is inappropriate, expensive and subjective, as it is unrealistic BDA to audit all wholesalers' stock as provided for in Article 227с, para 8, p.1. Refinements of Article 232a, para. 3 are needed, requiring the retailer to designate all distributors to whom order was sent and rejected.
• Provision of LMPHM norms, authorizing BDA to suspend the license of the economic entities and to disclose that to EMA in case of information provision refusal when auditing a certain participant in the supply chain.

BAMPTD has repeatedly stated its readiness to provide expertise on European practice and legislation regarding parallel distribution. Our arguments favor the effective and consistent European law that guarantees the Bulgarian patients' access to medicines. It is the parallel distribution of medicines that creates a real competitive environment, facilitating the medicinal products price market regulation in the Member States and should therefore be protected, tolerated and encouraged.

We declare our willingness to participate in the working groups on the draft law envisaged ordinances development in the section regarding Parallel Distribution.

We ask you to consider our arguments and we remain ready for a meeting with you to further discuss a regulatory framework that is consistent with the European regulations, sustainable and working in the name of patients.

Sincerely:

Boryana Marinkova

CEO of BAMPTD