News

• 20

  Jan 2017

  

  Draft Law on Pharmaceutical Activity

  Draft Law on Pharmaceutical Activity – for the first time after 87 years the law that specifically governs the pharmaceutical activity in the Republic of Serbia.




Draft Law on Pharmaceutical Activity

  Draft Law on Pharmaceutical Activity was published on the website of the Ministry of Health on 11th January 2017.

 

  The last law that specifically governed this field was the Law on Pharmacies and Medicines Trade Supervision of 1930. Thereafter the carrying out of the pharmaceutical activity was governed by the laws that regulated the issues of health care, such as the currently effective law: The Law on Health Care ("Official Gazette of the Republic of Serbia ", Nos. 107/2005, 72/2009 – as amended, 88/2010, 99/2010, 57/2011, 119/2012, 45/2013 – as amended, 93/2014, 96/2015 and 106/2015).

 

Draft Law on Pharmaceutical Activity was published on the website of the Ministry of Health on 11th  January 2017.  

The last  law that specifically governed this field was the Law on Pharmacies and Medicines Trade Supervision of 1930.  Thereafter the carrying out of the  pharmaceutical activity was governed by the laws that regulated the issues of health care, such as the currently effective law:  The Law on Health Care ("Official Gazette of the Republic of Serbia ", Nos. 107/2005, 72/2009 – as amended, 88/2010, 99/2010, 57/2011, 119/2012, 45/2013 – as amended, 93/2014, 96/2015 and 106/2015).

A public debate regarding the same is currently in progress and our office,  as the legal counsellor of some participants in this public debate,  has made comments on some of the articles. We highlight the following comments as the most interesting ones.____




• The issue of adopting the future Pharmacy Network, as a statutory instrument (Article 10),  causes  a great deal of disagreement among the representative associations from the field of pharmacy.  According to the published draft, the Network will be adopted by the Minister of Health at the proposal of the Pharmaceutical Chamber.  The criticism of the above-mentioned solution  leads towards the two, we may say,  extreme attitudes, and they are both motivated by the fact that the current structure of the membership in the Pharmaceutical Chamber does not reflect the equal representation of all interested parties. One of the proposals is that the adoption of the Pharmacy Network should be  entrusted to the Government of the Republic of Serbia, without the participation of the Pharmaceutical Chamber.  It would, therefore, lead to the complete exclusion of professional associations’ participation in the process of the Network formation. The other option that could be heard in the working bodies of some of the relevant participants of the public debate was that instead of writing only the Pharmaceutical Chamber, other relevant associations – currently the biggest ones (four of them in total) should also be written by name in the text of the Law. 

It is our opinion and proposal that the professional associations should certainly be enabled to participate in the drafting of the future proposals of the Pharmacy Network. However, by no means the associations that  currently have the biggest number of members  should be listed. Instead, the law should specify the criteria for representativeness of the associations that may participate in the working bodies on behalf of the profession. A good parallel can be made with the Labour Law and criteria for representativeness of trade unions. Thus, it is possible to ensure permanent and stable representation of the profession representatives  with full consideration of the fact that the membership structure in professional associations is changing, as members can move from one association to another.   

• The issue that causes the most controversies regarding the Draft Law is the relation of prescribed work requirements for pharmacy units of health care institutions (hospital pharmacies or  health care centre pharmacies) and private practice  pharmacies. We certainly propose that the requirements regarding the surface area of a pharmacy unit and a private practice pharmacy should be equalised. The arguments: ” The solution proposed in the Draft Law requiring larger premises (40 m2) for a pharmacy unit while retaining the existing solution for a private practice pharmacy (30 m2) represents a violation of equality.  Furthermore, there is no fundamental justification for introducing such difference. Having complied with the effective regulations,  a large number of the existing pharmacies of health care institutions  made big investments in the premises in which they carry out their activity.  The requirement that henceforth this activity must be carried out in larger premises must have a fundamental justification, otherwise there is a violation of the principle of acquired rights protection. Such justification cannot be given if the same activity may be carried out by private practice  pharmacies in smaller premises, which has been prescribed  for all pharmacies  until now. The argument that the private practice  pharmacies should be allowed to work in one shift only (more precisely, 8 hours a day excluding overtime) is not right, and in case they wanted to work in two shifts, they would have to meet the requirement regarding the size of the premises just like pharmacy units of health care institutions. First, through the institution of overtime (i.e. by allowing overtime work), private practice pharmacies are in fact allowed to work in two shifts. It will not be possible to apply the limitation of the maximum overtime working hours from the Labour Law to private practice pharmacies in which overtime work will be carried out by their owners, since the sanctioning of the violation of such limitation is entrusted to the will of the employees from whom their employers request to work overtime longer than it is prescribed. Second, the limitation to eight hours a day for private practice pharmacies has no justification, since two employed pharmacists do not work at the same time if they work in different shifts and, therefore, they do not need more space than one pharmacist. And third,  we point out that in the surrounding countries (Bosnia and Herzegovina and the Republic of Croatia) the same requirements regarding the  size of premises are prescribed for pharmacy units and private practice pharmacies “.

 

• Transitional and final provisions (Article 68) – In the published draft the transitional and final provisions are very sketchy.  We suppose that their more detailed regulation has been intentionally left for the version following the public debate.  We consider that an additional provision should be added itemising all the activities that would be considered as acts of harmonisation with the new law.

The longer time period for harmonisation – two years instead of one year. The time period of 2 years that we are proposing represents the protection of the investment in  the premises and equipment that has been made according to the then effective regulations by the entities that have carried out the activity until the new law is passed.
Furthermore, it is necessary to define that the existing pharmacies  which must change their location in the process of harmonisation with the new law may move within 300 m radius from the existing location. It should be specifically prescribed that the change of address for the harmonisation purposes (e.g. provision of larger premises in m2...) will not be treated as the termination of the existing pharmacy and the founding of a new one, as it has been the case until now, but it will be only treated as the change of address (of course, with compliance with the prescribed procedures on establishing whether the requirements regarding the premises, personnel and equipment have been met).
We also propose that a provision should be added  by which the existing pharmacies in the process of harmonisation will be exempt from fee payment to all government authorities when implementing mandatory changes for the purpose of harmonisation with the new law. An example is the change of the form of carrying out the activity - transformation of a branch into a pharmacy unit because of surface area in m2.

 

• In addition to the above-mentioned issues, there are also some other important issues that attract attention not only of the pharmaceutical and legal professions, but of the general public as well. For us the participation in the public debate is a professional challenge, but also an obligation, since the functioning of the pharmaceutical profession is one of the most significant concerns of the entire community.

• 10

  May 2015

  

  Whistleblower Protection Act – a novelty in Serbian legal regulations

  Whistleblowing is defined as disclosure of information that contain details on violation of regulations, violation of human rights, misconduct of incumbents of public office, threats to life, public health, safety and the environment as well as the prevention of large scale damage




Whistleblower Protection Act – a novelty in Serbian legal regulations

  As from 5th June 2015, the Whistleblower Protection Act (“Official Gazette of the Republic of Serbia”, issue No. 128/2014) shall be applicable. This Act entered into force on 4th December 2014 (hereinafter referred to as the Act). 
Whistleblowing is defined as  disclosure of  information that contain details on violation of regulations, violation of human rights, misconduct of incumbents of public office,  threats to life, public health,  safety and the environment as well as the prevention of large scale damage. A whistleblower may be an individual who discloses information in terms of his/her work engagement (employment, work outside the scope of employment, voluntary work, performance of a public function and any other de facto work for the employer), the employee recruitment process, use of services provided by state and other bodies, incumbents of public office or public services, business cooperation and ownership over a company.
This Act defines the procedure of whistleblowing to the employer,  competent body and the public, as well as rights and obligations of a whistleblower, employer and other entities.
The Act prescribes the following obligations for  employers:
-           to notify in writing all of its employees and other persons engaged in work of their rights under this Act;
-           to appoint a person who will receive information and conduct procedures relating to whistleblowing;
-           to regulate the process of internal whistleblowing by the internal act (rulebook), in case the employer has more than 10 employees, as well as to display it on the noticeboard and at the internet page, if it is technically feasible.
The employers must adopt their rule books by 4th December 2015.
The notice must be delivered to employees by 5th June.2015.
In case of violation of the above-mentioned provisions, high fines (pecuniary penalties) must be paid for the violation by a legal entity and entrepreneur, as well as by the responsible person in a legal entity, state body, territorial body or a local self-government unit.

A whistleblower shall be entitled to protection in case the conditions provided for under this Act have been met. Along with meeting additional conditions,  persons who will also be entitled to protection as whistleblowers will be an associated person, a person wrongly designated as a whistleblower, a person who disclosed the information in the line of his/her duty  and a person who requests the data regarding that information.
Abuse of whistleblowing is prohibited in terms of disclosing the information that was known to be untrue as well as with the intent to receive benefit for himself/herself,  with a request to act in relation to the information by which whistleblowing is performed.

The Act defines three types of whistleblowing:
Internal whistleblowing –  disclosure of information to the employer;
External whistleblowing – disclosure of information to the competent state;
Whistleblowing to the public – disclosure of information to the media, via Internet, at public meetings or gatherings or in any other manner by which such information may be made available to the public.. An employer or an authorized authority shall act upon anonymous disclosures within their competences.

The information disclosed in any of the above-mentioned manners may contain the whistleblower’s signature and his/her data, but not necessarily. An employer or an authorised authority must also act upon anonymous disclosures of information. The person authorised to receive the information must protect the whistleblower’s personal data i.e. the data according to which the whistleblower’s identity may be disclosed.  The information may also contain confidential data – the data designated as confidential or secret according to the regulations on data confidentiality. In that case,  a whistleblower may not disclose information to the public without prior notification to the employer or the employer’s executive/manager.

The employer must not put a whistleblower in an unfavourable position in relation to whistleblowing, by acting or failure to act, especially if such unfavourable position  is related to: employment, acquiring the status of a trainee or a volunteer, work outside the scope of employment, education, training or professional development, assessment, promotion at work or loss of position, disciplinary measures and penalties, working  conditions, termination of employment,  salary and other employment related benefits, share in the employer’s profit, payment of prize and severance pay, assignment or transfer to another work post, failure to undertake protective measures for the protection from harassment by other persons, sending employees to mandatory medical examinations or examinations for work capability assessment.
In case of any damage sustained due to whistleblowing, a whistleblower will be entitled to compensation for damage in accordance with the Contracts and Torts Act.
A whistleblower who has suffered damaging action in relation to his/her whistleblowing is entitled to file a lawsuit for protection in relation to whistleblowing with the High Court with territorial jurisdiction within six months as from the day the whistleblower learned about undertaken damaging action, but no later than three years as from the day such damaging action was undertaken. The lawsuit for protection cannot revoke the legality of the employer’s individual act used to resolve rights, obligations and responsibilities of an employee related to his or her employment. However, in the separate proceedings initiated by the lawsuit to revoke the legality of the individual act, a whistleblower may state that the employer’s individual act represents a damaging action related to whistleblowing.

• 07

  May 2015

  

  By the amendments to the Law on Employment, the circle of persons who are entitled to monetary unemployment benefit has been expanded

  On 7th May 2015 the Amendments to the Law on Employment and Unemployment Insurance (“Official Gazette of the Republic of Serbia” issues No. 36/2009, 88/2010 and 38/2015) entered into force whereby, inter alia, the article 67 was modified.




By the amendments to the Law on Employment, the circle of persons who are entitled to monetary unemployment benefit has been expanded

On 7th May 2015 the Amendments to the Law on Employment and Unemployment Insurance (“Official Gazette of the Republic of Serbia” issues No. 36/2009, 88/2010 and 38/2015) entered into force whereby, inter alia, the article 67 was modified. 
This article defines the conditions under which the insured persons are entitled to the monetary unemployment benefit after the termination of their employment.  The novelty is in the deletion of the words from the paragraph 1 point 1 sub-point 1 “in the process of streamlining, restructuring and preparation for privatisation”,  and in adding the paragraph 2 , whereby the circle of persons entitled to monetary unemployment benefits will be expanded.
Thus, ''an unemployed person whose employment or insurance was terminated of his/own free will or though his or her fault, i.e.  a person who has voluntarily chosen a severance pay, monetary benefit or special monetary benefit according to the Government decision setting the redundancy programme, in the amount exceeding the amount of severance pay stipulated by the Labour Law, he/she  may be entitled to the monetary unemployment benefit if he or she meets again the requirements under the article 66 of this Law“  i.e. if he  or she is insured for at least 12 months continuously or intermittently within the past 18 months.




• 04

  Dec 2013

  

  Moving into new business premises

  The law office Marković & Associates moved into the new business premises in Palmotićeva Street in Belgrade.




Moving into new business premises

The law office Marković & Associates moved into the new business premises in Palmotićeva Street in Belgrade. Our moving into the new office was marked on a cocktail party and one of the gifts was the new 3D office logo on the wall of the reception hall.