The African Business Journal: PIASA PIASA ================================================================================ admin on 12 February, 2010 09:21:00 The continuing viability and growth of the pharmaceutical industry in South Africa is vital if South Africa is to maintain its access to world-class innovative medicines and have access to a growing generic medicines market. So says Vicki Ehrich, chief operating officer of the Pharmaceutical Industry Association of South Africa (PIASA), which, as the longest established pharmaceutical association in South Africa, represents 19 pharmaceutical companies. The mission of the association is to sustain a favourable environment for the continuous development of the industry while striving to give South Africans greater access to innovative and generic medicines with a common goal—to improve the health status of the population and to assist the government in delivering better healthcare to more people. The pharmaceutical industry is operating in an ever-changing and increasingly hostile environment. Not only does the industry, worldwide, face increasing challenges in terms of pressure on pricing and pressure on intellectual property, but there is now increasing pressure to address the needs of developing countries, the research needs for unmet medical conditions and to assist in addressing the burden of disease in low income countries. This is forcing a change in the model on which the industry operates and is resulting in changes and consolidation across the industry. Within this worldwide context, the South African pharmaceutical industry is facing constant change to which PIASA is responding on behalf of its members. Since 2004 price regulation has become a reality with a move to a Single Exit Price system, which disallows any price variation based on client or volume, with the exception of supply to the government sector. Recent government announcements with regard to the imminent introduction of a national health system have created wide-scale debate on the matter. Access to healthcare and medicines is a key government priority and although there is currently universal access to healthcare, the quality of care and the equitable distribution present challenges to be addressed in the design of the system. “PIASA represents both multinational companies and local companies,” says Ehrich. “There has to be a balance in the encouragement of innovation and the promotion of generics,” she continued. “While research-based companies introduce new products to the market, this creates a pipeline for generic manufacturers which are then able to launch their own versions once the patent expires. Without this R&D presence of the multinationals we would not have access to the new innovations and a strong generic pipeline.” “PIASA has celebrated several successes over the last year,” newly elected PIASA president, Dr. Jonathan Louw highlighted at a recent PIASA member conference. In line with the Broad-Based Black Economic Empowerment (B-BBEE) Act, the PIASA membership has made transformation a key priority. “We encourage our members to embrace transformation as far and as swiftly as possible and we’re assisting them to move towards obtaining a rating so we can calculate an industry benchmark by consolidation of their scores,” says Ehrich. In a recent survey of the membership, 12 of 17 respondents indicated that they intended to be rated on their B-BBEE scorecard at the end of the 2009 financial year—a huge move forward on the one or two companies that were rated previously. Due to a constructive partnership between PIASA and other industry associations, the Code of Marketing Practice has been developed. The Code is in line with a word-wide trend to maintain ethical standards and transparency in the dealings of the industry with health professionals. PIASA was very active in offering input to the recent Ministerial review of the regulatory services of the Medicines Control Council (MCC), while delays in the registration of medicines and the approval of clinical trials are key blocks for manufacturers in South Africa. This process led to the approval of a new regulatory authority, which is designed to overcome many of the drawbacks seen in the existing system. The industry looks forward to an implementation of the new system in the forthcoming years. The lack of harmonisation in regulation creates many headaches for the local industry. Surrounding territories all have varying requirements in terms of registration and packaging requirements. PIASA has effectively and proactively engaged with external health authorities in the Southern African region, e.g. Namibia, regarding technical issues affecting members as well as updating pharmacovigilance guidelines. PIASA has recently re-launched their website, which is intended to be an information resource for such as the media and interested consumers as well as for members. “The newly refurbished website has been a culmination of our objective to escalate our communication activities and to raise our profile. This new portal to PIASA is intended to be a resource site of accurate and relevant industry related information for members, journalists and the public alike.” www.piasa.co.za