Situation in Forensic Chemistry Laboratories: briefing by the Department of Health; Medicines Control Council on Criteria for Registering Medicine, Current Backlog and Challenges

Meeting report

Opening Statement
The Chairperson informed the Committee that a Member, Ms M Dube (ANC), was admitted to Chris Barnard Hospital. The Committee had to decide when they could visit her. Ms Dube had contracted a disease called sarcoidosis, which was treated with steroids. Sometimes, people developed diabetes mellitus from using steroids.

Department of Health (DoH) Briefing on Forensic Chemistry Laboratories
Ms Melebona Matsoso, Director-General, DoH, informed the Committee that there was a capacity problem within the Forensic Chemistry Labs (FCLs), but the Department was looking at ways to address the problem. The Department had already submitted a request to the National Treasury (NT) asking for additional funds.

Professor Melvyn Freeman, Cluster Manager: Non-Communicable Diseases, DoH, briefed Members on the functions of the FCLs. FCLs were involved in toxicology analysis, blood alcohol analysis and food analysis. He also explained the vacancies in the Cape Town, Johannesburg and Pretoria laboratories. The Johannesburg FCL did not have anyone to head the lab. There was a vacancy for one section head, one analyst, and one administrative assistant. The Cape Town FCL had a vacancy for one section head, one analyst and five lab assistants. The Pretoria FCL had a vacancy for one section head, four analysts, two lab assistants and one administrative assistant. A work-study assessment was conducted by the Department. It recommended that an extra twelve posts be created in the Cape Town and Pretoria FCLs. The Johannesburg FCL still had to be assessed, but this was not possible until all the renovations on the building could be completed.

The length of time that it took to conduct a toxicology analysis was variable. A case could be completed within a week, but very often an analyst had to go through a whole range of possible alternatives before the correct one was found. A “reasonable” timeframe for an analysis to be complete was two months, but this could be longer depending on the circumstances.

The Department had developed some interventions to deal with the problems. It had delegated responsibility for procurement of goods and services up to R150 000 to the lab heads as a way to fast track the provision of chemicals and repairs to equipment. Critical vacant posts were advertised and a short-listing of names had already been completed. A number of lab staff had undergone training to keep up with the latest scientific developments and to see to the running of lab information management systems. The Department had investigated contracting outside workers but this seemed too expensive. As a result, overtime was allowed wherever funds permitted it. The Department had already started negotiations with the National Prosecuting Authority (NPA) and the South African police Service (SAPS) to establish whether all the samples received from them still required analysis.

The key to resolving all the challenges were to acquire extra funding. While efficiency gains could be made through less rigorous procurement practices and more motivated staff, mechanisms still had to be put in place to retain staff, to ensure adequate supplies were made available where needed, and to ensure machines could be fixed when they broke. Additional funding was needed to address the backlogs faced by the FCLs.

The Department requested funding from the NT for the current year and although some money had been given, it was not enough to meet the challenges that the FCLs faced. As a result, the Department had put in a new bid to the NT. If granted, this funding would be used to recruit and retain staff, to ensure that goods and services that were required would be made available, and new equipment would be bought. Management support would be provided and staff would also work overtime to deal with the backlog.

Discussion
The Chairperson stated that forensic laboratory services were supposed to assist police in solving crimes. He could not understand why it did not form part of the National Health Laboratory Service (NHLS). He feared that the FCLs were not performing well, but the Committee was hopeful after the presentation that problems would be addressed.

Ms Matsoso replied that the Department was in discussions with the NHLS. The Department had asked the NHLS if it could provide the FCLs with additional analysts in order to address the backlogs. If this is possible, the Department and the NHLS would be entering into a Service Level Agreement (SLA) that would allow the Department to access their scientists and analysts. 

Prof Freeman added that he was still trying to understand why the labs were not included in the NHLS. He assumed it had something to do with salary scales and qualifications. According to the NHLS, analysts signing off samples had to have a four-year degree, but people working for the FCLs had three-year degrees.
The Chairperson expressed concern that the Department did not elaborate on the corruption that was happening within the FCLs and forensic services in general. As a result, he asked if the Department dealt with many cases of corruption.

Ms Anika Shillock, Head of the FCL in Cape Town, replied that there were measures in place to keep corruption at bay. Security accompanied all samples when they were being tested. There were security cameras installed everywhere in the building. The sample information was also loaded onto the Laboratory Information System. If any anomalies were detected, such as serial numbers that did not correspond, then a report was filed and signed by a police official and administration clerk. When the sample first came to the lab, it was given barcode number that had to be scanned every time it was taken out of storage. Personally, she had not received any reports where samples had been tampered with. However, there had been cases where insufficient samples were taken. It was possible that there was corruption from that side of things.

Prof Freeman added that the Department and the labs would continue being vigilant where corruption was concerned.

The Chairperson noted that South Africa was a big country and there were only three FCLs. How long did it take for samples to reach the labs and for people to receive the results if they lived far from the labs?

Prof Freeman replied that this was not really a problem. The problem occurred when analysts were called to testify in courts in other cities. This took time and money. If the labs had a more decentralised service, then this could be avoided. Kwazulu-Natal had the skills and resources to run a FCL, unlike smaller provinces that would not be able to. Parts of the labs, such as food testing could be more decentralised if it was more closely linked with the NHLS.

The Chairperson asked whether the FCLs worked together with the South African Institute for Drug-Free Sport.

Prof Freeman answered that drugs in sport was not part of the Department’s mandate.

Mr E Sulliman (E) noticed that the vacancy rate was very high. He knew that the Department was in the process of shortlisting people to fill the vacancies, but it did not say if all the vacancies were going to be filled.

Prof Freeman agreed that the vacancy rate was very high and was the major cause of the backlogs. At the moment, the labs were getting more samples than they could handle. Therefore, the output of results was much less than the amount of samples being received. More people were needed if the problem was going to be addressed. In Johannesburg, the position for Head of the FCL was just recently advertised. The other positions could not yet be advertised as the lab was not working at its optimal level due to renovations that were taking place. Once the renovations were completed, the positions would be advertised. Seven posts were advertised for the Cape Town FCL and five posts were advertised for the Pretoria FCL.

Mr M Waters (DA) informed the Department that he had visited all three laboratories a few months ago. He noted that all three labs did not meet health and safety standards. The Pretoria FCL did not even have a fire escape.

He addressed the issue of backlogs, asking how long it would take to eradicate the backlogs. The presentation showed the length of time it took to conduct a toxicology analysis (Slide 7). It said that a test could be completed within a week, but very often the analyst had to go through a range of possible alternatives before the correct one was found. According to the slide, a “reasonable” time for a toxicology analysis to be completed was two months. But, when he had visited the FCLs, he found that the backlogs for toxicology in the Cape Town FCL were seven years, the backlog in Johannesburg FCL was eight years, and Pretoria was four years. Families were unable to move on with their lives without these results, as the reports had to be submitted to insurance companies. On drunken driving, the backlog was between 12-16 weeks in the Cape Town FCL, approximately three years in Johannesburg and 16-18 weeks in Pretoria. In Cape Town, the backlog for food sample reports was eleven months, it was three years in Pretoria and Johannesburg did not do food sample analysis. He did not know how the Department could say that the time taken for the analysis to be complete was two months. If the Department wanted the Committee’s help, it had to be honest with Members and should not try to hide certain information. He asked for an explanation. How long would it take to eradicate the backlog?

Ms Matsoso replied that the Department was aware of the backlog. It was in the process of quantifying the backlog so it could know the amount of people that were needed in the labs to address the problem. The current number of staff could not keep working overtime to address the backlog.

Prof Freeman added that the Department prioritised the solving of crimes. The Development Committee of the Criminal Justice Cluster had been tasked to develop strategies to speed up criminal justice processes. The Committee had identified the FCLs as one of the obstacles in speeding up the criminal justice processes. It had therefore supported the Department’s bid for more resources for the FCLs.

Prof Freeman agreed that there were health and safety issues in terms of the buildings the labs were situated in. he did not know what else to say about the matter, but something had to be done about it.

He noted that Mr Water’s had asked how long the backlogs were, and he had answered the question himself. If the figures had changed over the past few months, it had changed by very small amounts. The Department would provide the Committee with the information. The large backlog was due to the shortage of staff, even though most of the lab workers did quite a lot of overtime. In order to alleviate the backlog properly, the FCLs needed to get the right staff and equipment. Very often, many people with the right skills applied for the posts in the FCLs. Unfortunately; there was not enough money to employ all of them. It was not possible to give the Committee an exact timeframe for when the backlog would be eradicated as he did not know how long it would take to employ all the right people and train them.

Mr D Kganare (COPE) asked if the Department was receiving enough applications when they advertised posts. He was aware that there was a shortage of skills in the country.

Ms Matsoso replied that the shortage of skills was an important matter that had to be addressed. The analysts’ levels of skill and experience differed. It was quite clear that some people were more experienced than others. The skills level in the country was variable; however, there was a problem of morale. People that worked in labs, conducting the same tests over and over generally lost some morale over time.

Ms Shillock assured the Committee that the FCLs were receiving many applications for the posts. However, it was the interviews that would show how competent and experienced people really were. Applicants needed chemical knowledge as well as communication shills. It was unfortunate that the salaries offered were so low that the labs could not attract as many people as they would have liked to. Another problem was retaining analysts once they were trained. 

Mr Waters said that whenever any health entity appeared before the Committee, it had to give Members any information it had on backlogs, if it had any. It was misleading when entities came before the Committee and did not give the full information and details about problems like backlogs. He proposed that slide 7 of the presentation be removed as it was inaccurate.

Prof Freeman explained that the Department had been asked how long it took for a toxicology report to be completed. The Department thought that the Committee wanted to know how long it took to write the actual report. He apologised for the misunderstanding.

Mr Kganare noted that Prof Freeman had spoken about decentralising some of the labs’ services. He wondered if the services would improve if they were decentralised and more people employed to assist in the labs.

Prof Freeman replied that the Department had been looking at the decentralisation issue, also in terms of where the labs would be better placed. In terms of the NHLS Act, the labs could be part of the NHLS. If this was to happen, then decentralisation could take place more easily and faster. However, labs were quite specialised and needed strict security measures. The more labs there were, the more security would be needed, and the more difficult and expensive it would be to maintain the labs. The control of the labs could slip quite quickly if there were too many labs. There was also a skills issue. The Department could not be sure that it would find these specific skills in certain provinces such as the Northern Cape.

The Chairperson added that he did not think that three labs were enough for the whole country. However, he was aware that there were challenges such as the lack of funding and the staff shortage.

Medicines Control Council Briefing
Ms Mandisa Hela, Registrar of Medicines: Medicines Control Council (MCC), briefly explained the aim of the National Drug Policy (NDP), which was to ensure that medicines reaching patients were safe, effective and met approved standards and specifications.

The registration of medicines was premised on safety, efficacy and the quality of the product. New Chemical Entities (NCEs) were put through a preclinical stage where they were tested on animals to assess their pharmacodynamic, pharmacokinetic and toxicological profile. Phase two of the study looked at efficacy while phase three involved the medicines being tested on a large number of participants over a period of time to determine safety and efficacy. A Fixed Dose Combination (FDC) was a product with two or more components combined into one to reduce pill burden and improve adherence. The registration of these medicines was guided by a number of factors. The MCC had to look at whether there was enough data on each molecule to support efficacy and safety, whether there was sufficient data to show that when combined the efficacy was improved, and whether each component would be released in a therapeutically efficacious manner.

Once applications for the registration of medicines were submitted, relevant parts of the application dossier were assigned to different evaluators according to their expertise. Reports were peer reviewed by at least four expert committees to ascertain that manufacturing sites currently met Good Manufacturing Practice Standards. Committees met every eight weeks. Peer review reports were then submitted to the MCC with a recommendation to register or reject the application.

The MCC was in the processes of addressing their application backlog. A project team was appointed a year ago and additional technical assistants and evaluators were appointed to assist the MCC. The MCC established an off-site storage facility for old files and secured fir-proof shelving for its current files. The MCC also augmented funding for the implementation of an Electronic Document Management System (EDMS). The total outstanding number of pending applications amounted to 2700. Pending applications included all applications that were not finalised at the behest of the applicants and those still under evaluation. The number of unregistered products from the backlog amounted to 1240. The MCC was in the process of contacting applicants who had not yet responded to recommendations made by the MCC for more than a year now. They were also contacting applicants that requested extensions to stipulated timelines for data. The current backlog for pending applications was 108 in 2003, 99 in 2004, 168 in 2005, 321 in 2006 and 647 in 2007.

The MCCs challenges included over-reliance on external evaluators, a substantial increase in the volume of safety related post registration updates, pro-generic medicine policies were not matched to personnel needs, reliance on the general budget allocation and poor quality of some submissions for evaluations. 

Discussion
The Chairperson asked how long the preclinical stage of testing took and how much it cost. He was aware that many South Africans used traditional medicine. He asked if complementary medicines and traditional medicines were also put through the preclinical stages. The MCC said that there were some products that were being evaluated externally. He stated that this seemed like an area where there could be quite a bit of corruption. He asked if the MCC was aware of any corruption and if they dealt with corruption issues. Was it a good thing that the MCC was part of the Department or would it be better if it was outside of the Department?

Ms Matsoso replied that a study had been done, which showed that the longer a product took to be registered in the system the more expensive it became, especially if there was no competition in the market. So, the regulation and registration of medicines definitely impacted on their costs. Therefore, it was important to have an efficient regulatory system.

Traditional and complementary medicine was always a problem as they were a part of an unregulated market and this defeated the purpose of ensuring the safety and efficacy of medicines. Herbal medicines coming into the country from other countries could not be defined as traditional medicine, as they were not traditional in the South African sense and had to be regulated.

Professor Peter Eagles, Chairperson, MCC, added that there was a lot of interest in traditional and complementary medicine from a research aspect; however, the medicines had not been given a “stamp of approval”. There was a Complementary Medicines Committee that was almost ready to present a list of regulations for complementary medicines to the Minister. There was a special committee for traditional medicines as it was a special group of medicines that needed a lot of attention. Right now, the MCC was focused on Complementary and Alternative Medicines (CAMs).

Prof Eagles said that all members in the MCC had to declare their interests each year. From time to time, the MCC had to use external experts who had conflicts of interests. But this was only if the MCC needed their opinion on one product. These experts were asked to sign a confidentiality agreement so that they are unable to use the information for their own financial benefit. Corruption in the regulatory system was possible. However, on average, each medicine was put through five different committees for evaluation. It also had to go through 24 more people on the MCC. All Council members were quite independent; they did not work for the government or industry. Most of the members came from universities and hospitals.

Mr Waters thanked the MCC for addressing their backlog. However, it would have been better if Members had been informed of the entire backlog in the future. The Committee needed backlog figures for 2008 and 2009. The Minister said that he hoped the backlog would be eradicated within a year. He understood that the MCC had experienced many challenges, but he wanted to know when the MCC thought the backlog would be eradicated. The presentation did not mention if the MCCs law enforcement division was dealing with any cases in particular. He asked if any progress had been made with the investigation into the sale of Ubejane traditional medicine as it was still being sold in Kwazulu-Natal.

Ms Matsoso addressed the question on the law enforcement division of the MCC. She thought a combination of police and inspectors were needed to monitor regulated and unregulated medicines.

Prof Eagles replied that the MCC had made a statement saying that Ubejane had not been credited by the MCC. If it was still being sold, it would become a legal issue. The MCC had never started legal proceedings with anyone; the matter was usually reported to the Department and the Director-General would then decide what to do. There were a number of cases that were being appealed at the moment, as many MCC decisions were challenged. The MCC did not mind that its judgments were being questioned because it was good for people to see that the MCC was so strict.

Ms Hela answered that in 2008, the MCC had received 762 applications for medicines to be registered. So far, 62 drugs had been registered. In 2009, the MCC had received 1533 applications. So far, 41 had been registered.

She was not sure when the backlog would be eradicated. This was a difficult question to answer. Many applications had been sent back with queries from the MCC that the applicant had to respond to. She did not know when they would respond to the queries. The MCC would update the Committee after the Council met in December.

The Chairperson said that the drug, Cytotec was being used for abortions. It was a dangerous drug that was killing people, and was being sold on the streets. He asked the MCC for more clarity on the matter.

Ms Matsoso replied that Cytotec was a scheduled drug and access to the medication was therefore limited. This was an area that needed careful attention.

Prof Eagles added that the distribution of Cytotec as a means to an abortion had been a problem for a long time. The MCC had even spoken to the company producing Cytotec on the subject of abortions and how Cytotec softened the cervix. The MCC had asked the company at the time if it would include this information in the insert that was contained in the Cytotec packaging to tell people that it could be used for abortions. The company refused to do it because of all the controversy surrounding abortion. The company in question had said that if the government wanted to use it, it could use it “off-label”, which meant that it could be used for something other than what was included in the packaging. However, then the government would be responsible for any mishaps. There was a set of criteria that could be used for “off-label” use. One criterion said that it could be used if the drug received approval at an international level. But, according to law enforcement, if people were selling the drug off prescription, then it was illegal. The MCC wanted to encourage people that wanted to use Section 21 drugs to be guided by their doctors. At the end of the day, the MCC had to ensure that medicines were safe and effective.

Ms M Mafolo (ANC) stated that there were important medications that were being sent from other countries that were being held up or blocked in South Africa. Some of these medicines were very important.

Ms Matsoso explained that the South African Health Products Regulatory Authority (SAHPRA) was being developed to ensure that there would be a critical mass of technical experts that would provide sound regulatory support for evaluations and inspections. 

Mr Waters addressed the Ubejane matter again. There were people who were discouraging HIV positive people from taking their Antiretroviral (ARV) medication, and telling them that Ubejane could cure AIDS. Rigorous legal action had to be taken against these individuals. He appealed to the Department to look into this as it was a matter of urgency.

The Chairperson added that Members had a responsibility to represent and protect the people that voted them into Parliament. He wondered if the Committee should take up the matter themselves.

Ms Matsoso replied that there were certain sections of the Medicines and Related Substances Control (MRSA) Act that could be used to address the problem. The Act said that the MCC could make certain information available to the public. This could be used to inform people of the potential risks of using Ubejane. The Department would send inspectors out into the areas where Ubejane was being sold.

Mr Waters stated that his predecessor, Ms D Kohler-Barnard (DA), who served in the Health Committee a few years ago, had laid charges against an individual in terms of the MRSA Act. However, the police said there was no record that a case had been opened against this person.

The Chairperson said that the Committee and the Department, as well as a representative of the MCC, would have to get together to discuss the matter. This was a matter that had to be discussed.

The Chairperson thanked the MCC for their presentation. The meeting was adjourned.