The Sunday Leader

Recommendations On New Drug Regulatory Bill

  • For a civil society collective on health policy issues

By Lionel Guruge

The National Medicinal Drugs Regulatory Authority (NMDRA) Bill of 2015 was presented in Parliament on March 3, 2015. This is one of the actions within the 100-Day Plan, which includes promises made at the recent election.

We have to appreciate this initiative by the current government in bringing this hidden topic to the limelight. The Minister of Health and the government are hurrying this matter along within this set time frame, but other political parties, civil society organizations and activists are of the belief that this should be subject to debate and very careful consideration before finalisation.  This is because on a national level this a very crucial Act, with critical impact on the people of the country, and rushing it may have serious repercussions.

The people expect quality medicine of a trusted standard at an affordable price; this will not necessarily be brought about merely from the passing of such policies. There should be a definite vision with a detailed plan of action including improved testing, a situation audit to analyze levels and opportunities of local production and empowerment of the State Pharmaceutical Corporation. Most importantly there should be transparency.

Due to information being available only in English, the current situation with regard to public understanding on medicines and medical devices is absolutely dismal.  Information on medicines should be available in Sinhala and Tamil which are the official languages of the country so that citizens can participate in informed debate on this critical topic and receive knowledge on health matters without barriers.

Prof, Seneka Bibilie’s Health Policy should be adjusted to suit the present era and this debate should be enriched by the government, opposition, media, civil society activists and those in the medical profession. However, currently little is known of the contents of this bill; it has hardly been available for public scrutiny and so it may be passed in Parliament without the informed consent of the people it impacts.

Civil society representatives who had a chance to analyse the English Text of the NMDRA Bill in the short time span available have identified a number of potentially serious shortcomings. Along with recommendations for amendment these are noted below for attention of parliament and for further public dialogue:

First noted was the call to repeal the Cosmetics, Devices and Drugs Act, No. 27 of 1980. This has the effect of leaving basic cosmetic products unregulated and addresses medical cosmetics, which falls under the definition of ‘Borderline Products’. If there is no clear representation and proper regulation under a specified authority, cosmetic products circulated within Sri Lanka will not be regulated and assessed for quality, which can lead to unfortunate and dangerous situations. Therefore we recommend that the Cosmetics, Devices and Drugs Act of 1980 not be repealed.

Chapter 1, Part I Article 4(a) states the Constitution of the Authority (that is the National Medicines Regulatory Authority, which will be appointed to monitor and give provisions for the safe practice and distribution of medicines and medical devices). But, the process of appointing the ex-officio members that will constitute this Authority (the DGHS, Treasury Secretary and CEO) has not been specified. Subsection (b) of this article mentions that the members that will be appointed by the Minister of Health would have gained ‘eminence’ in various fields. We believe this is vaguely defined and provides room for abuse. The list also does not provide for representatives of fields such as nursing, which is arguably a large constituent of professionals who should be involved. We therefore recommend that this article be re-phrased with more specificity.

Under Chapter 1, Part I Article 5 (1), it is stated that “The Minister shall appoint one of the appointed members to be Chairman of the Authority”. Although it is acknowledged that the Minister must appoint the Chairman of the Authority, the nomination of the Chairman should not be in the hands of the Minister; instead, it should preferably be by consultation with and nomination by the members of the Authority. Therefore it is recommended that the phrase “The Minister shall appoint…” be replaced with “in consultation with and nominated by the members of the Authority”. An alternative would be to allow the Constitutional Council arising through the proposed 19th Amendment, to nominate the Chairman.

Under subsection 3 of the same Article it has been subsequently mentioned that “The Minister may for reasons assigned remove the Chairman from the office of the Chairman”, which we recommend should also be in consultation with the members of the Authority.

Article 6(3) of Part I states that “No person shall engage in any employment or assignment in the pharmaceutical industry within the period of three years immediately after such person ceased to be a member of the Authority”. Any member that has been involved in the pharmaceutical industry prior to being appointed as a member of the Authority will also bring with him/her a certain element of bias and vested interests. Therefore we recommend that in addition to not engaging in employment three years after ceasing membership in the Authority, they must also have no engagement 3 years prior to their appointment as well.

According to Article 9 (1) of the same Chapter and Part, “Every appointed member of the Authority shall, unless such officer vacates office earlier by death, resignation or removal, hold office for a period of three years, and shall be eligible for re-appointment, unless removed on disciplinary grounds”. The phrase “shall be eligible for re-appointment’” is not specified accurately. By this statement, a member of the Authority may gain the right to be re-appointed as many times as he/her wishes. Due to this fact, we recommend that the number of terms a member of the Authority may be re-appointed must be specified; and preferably limited to a maximum of one additional term above his/her first appointment.

Part I of the same Chapter, Article 10 (1) is dedicated to the Meetings of the Authority. However, the frequency and nature of these meetings are not specified in the Bill. Such specifications are necessary to ensure a clear method of conduct is being implemented. If not, meetings might be delayed or not held and important matters that need discussion might be avoided. Therefore it is recommended that the frequency and nature of these meetings must be specified. The ambiguity about meetings also appears in Chapter II Part II which is dedicated to the National Advisory Committee that is to be instilled to supervise the proper implementation of the bill, the National Medicines Policy, and to advise the Minister and Authority.

Article 10(2) (b) states that “in the event of an equality of votes on any question considered at a meeting the Chairman of that meeting shall have a casting vote in addition to his original vote”. This may allow the Chairman to instill his authority unduly. For these reasons we recommend that this Article must be clarified and an alternative solution be provided.

Under Part III Article 18(2), sub categorized as ‘Finance’, it is stated that “all such sums of money as may be received by the Authority by way of loans, donations, gifts and grants from any source whatsoever”. Allowing funds to be  received from any source whatsoever can  pave the way for the Authority to be funded by any corporate industry or any other group or company with vested interests, thereby subjecting the Authority to a clear conflict of interest. Therefore it is strongly recommended that the sources by which the Authority may receive funds must be clearly dictated in the legislation.

Part IV Article 24 speaks of the Declaration of Secrecy within the Authority. According to the Bill, “Every member of the Authority and all officers and employees of the Authority shall, before entering upon duties, sign a declaration pledging to observe strict secrecy in respect of all matters connected with the affairs of the Authority, which has come to his knowledge in the performance of exercise of his powers and functions under this Act and shall by such declaration pledge himself not to disclose any such matter..”. Although secrecy pertaining to the functioning of an organization can be justified, to pledge not to disclose any information is a direct violation of the citizens Right to Information which is the subject of separate emerging legislation. Therefore it is of utmost necessity that this bill should specify what information will be withheld from the public with reasons.

Chapter II, Part II Article 31 mentions the membership of the National Advisory Committee. The membership according to this bill includes (a) the Director General of Health Services, and (c) the Chairman of the Authority. Since these two members are already a part of the Authority, to further include them in the National Advisory Committee would be an impediment to the constructive progress of the Advisory Committee. As to avoid such an occurrence, we recommend not to include both members into this Committee. Under the same Article, (t) includes membership from “a representative from a patient interest group nominated by the Minister of Health”. Instead of this member being appointed by the Minister, we believe that it may be more appropriate to allow an amalgamation of patient interest groups to nominate a representative amongst themselves. Furthermore, (w) states that in order to represent the public’s interest, “a representative of the public nominated by the Minister” can be given membership into the Advisory Committee. As past actions may have come to prove, such a statement allows those in power to exercise their authority to their own benefit. Therefore it is highly recommended that the selection criteria for nomination of this candidate be transparent and specified. One such recommendation would be the parliamentary committee to nominate a candidate from its constituency.

Under Chapter III, Part III ‘Offences Pertaining to Medicines’, Article 56(4) states that “Where the brand name of the medicines, which is in the prescription is not available or affordable to the customer, the Pharmacist may dispense any other brand of the same generic medicine with the consent of the customer”. To allow the Pharmacist to distribute only a brand of his/her choice even if it contains the same generic component as the one being prescribed can allow large Pharmaceutical companies to gain an unfair advantage in the medical sector. Therefore it is recommended that in addition to the ‘brand’ name, the Article should instead be phrased as “the Pharmacist may dispense any other generic, branded generic, or failing which, a brand of the same generic medicine…” By rephrasing this legislation, the assumption is that the room for unfair and/or corrupt practices will be tightened.

Chapter IV Part III Article 77 mentions the Offences Pertaining to the Medical Devices. It states that “No person shall label, package, treat, process, sell, assemble, distribute or advertise any medical device in a manner that is false, misleading, deceptive or likely to create an erroneous impression regarding its safety and efficacy”. However, it does not mention what language the labels of these medical devices will be printed in. In  fact, at no point in this bill does it mention what languages will be printed on the labels of medicinal drugs and devices. In accordance with the 13th Amendment of the Sri Lankan Constitution as well as the Official Languages Policy, all products must be distributed with both a Sinhala and Tamil print, as per the right of the citizen to be served in his/her official language. Therefore it is strongly recommended that to protect patients interests, the labeling of medicinal drugs and devices should include a provision to be labeled in both official languages of Sri Lanka instead of only English.

Under  Chapter VI Part I Article 108(2) it is mentioned that “the Authority shall cause notice of the ban or withdrawal from use of medicine, medical device or borderline product in terms of this section, to be published in a daily newspaper in Sinhala, Tamil and English or website of the Ministry or broadcast over any electronic media”.

By this statement, the Authority can essentially post the banning of a product on the Ministry website alone, and declare its duties accomplished, leaving a vast majority of citizens who have no access to such portals in the dark. Therefore it is our recommendation to substitute the word ‘or’ with ‘and’, so that citizens are educated from all portals available.

Finally chapter VII Part 4 Article (132) “Every person who commits an offense under this Act….may be arrested without a warrant” It is recommended that this be adjusted to require a warrant.

One major omission noted in this bill by a member of the medical community is provision on the regulation of clinical trials. It is mentioned only as an objective but not as a power of function. It is not understood why clinical trials which are a vital component in the medical sphere have been left out of such an important piece of legislature.

A main issue that needs to be accounted for when drafting a bill of this nature is the avoidance of corruption. For that reason it is of paramount importance to execute the plans of this bill with utmost transparency and accountability for conflict of interest.

For this purpose, it is also recommended that the technical and other officers and employees of the Authority (as mentioned in Chapter I Part II Article 16 (1)) should undergo a conflict of interest declaration and if any experts on relevant subject matter is invited for meetings (as stipulated in Chapter I Part I Article 12 (a)) they must also undergo the aforementioned conflict of interest declaration.

Once signed, all declarations should be available in the Health Ministry website and be updated regularly to ensure complete accountability and transparency.

Finally it is recommended that the references to quality drugs at affordable prices should not be removed as need and cost are the fundamentals of Prof. Seneka Bibiles’ and the present policy.

With these recommendations in place, it is hoped that the NMDRA bill will be executed professionally and transparently, and protect and benefit the citizens of Sri Lanka.

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